Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Vaxigrip suspension for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Influenza virus inactivated split (h1n1, h3n2-like, b/brisbane/60/2008-like, strains) may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Vaxigrip is a vaccine. This vaccine administered to you or your child from 6 months of age helps to protect you or your child against influenza (flu). When a person is given the vaccine Vaxigrip, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Sections 2 and 3). None of the ingredients in the vaccine can cause flu. The use of Vaxigrip should be based on official recommendations. Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated. Vaxigrip is intended to protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection. In addition, if you or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness as the incubation period for flu is a few days. The vaccine will not protect you or your child against the common cold, even though some of the symptoms are similar to flu.
2.
What you need to know before you or your child use Vaxigrip
To make sure that Vaxigrip is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain. Do not use Vaxigrip
- If you or your child are allergic to:
- The active substances, or
- Any of the other ingredients of this vaccine (listed in Section 6), or
- Any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde or octoxinol-9. Warnings and precautions Talk to your doctor or pharmacist before using Vaxigrip. You should tell your doctor before vaccination if you or your child have: •
A poor immune response (immunodeficiency or taking medicines affecting the immune system),
•
Bleeding problem or bruising easily.
If you or your child have an acute illness with fever, the vaccination should be postponed until the fever is resolved. Your doctor will decide if you or your child should receive the vaccine. Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with a previous injection. As with all vaccines, Vaxigrip may not fully protect all persons who are vaccinated. Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will be protected. Children Vaxigrip is not recommended for use in children below 6 months of age. Other medicines and Vaxigrip Tell your doctor or pharmacist if you or your child are receiving, have recently received or might receive any other vaccines or any other medicines.
- Vaxigrip can be given at the same time as other vaccines by using separate injection sites.
- The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, ask your doctor or pharmacist for advice before using this medicine. Vaxigrip can be used in all stages of pregnancy. Vaxigrip may be used during breast-feeding. Your doctor/pharmacist will be able to decide if you should receive Vaxigrip. Driving and using machines Vaxigrip has no or negligible influence on the ability to drive or use machines.
Vaxigrip contains potassium and sodium This medicine contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e. essentially 'potassium-free' and 'sodium-free'.
3.
How to use Vaxigrip
Dosage Adults receive one 0.5 mL dose. Use in children and adolescents Children from 6 months to 17 years of age receive one 0.5 mL dose. If your child is less than 9 years of age and has not been previously vaccinated against flu, a second dose of 0.5 mL should be given after at least 4 weeks. If you are pregnant, one 0.5 mL dose given to you during pregnancy may protect your baby from birth to less than 6 months of age. Ask your doctor or pharmacist for more information.
How to take it
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin. If you or your child receive more Vaxigrip than you should In some cases, more than the recommended dose has been inadvertently administered. In these cases, when side effects were reported, they were in line with what is described following the administration of the recommended dose (see Section 4). If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. If you experience an allergic reaction, contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away. Allergic reactions They can occur immediately after vaccine administration and may be life-threatening. Symptoms may include:
- Rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, low blood pressure, rapid heart rate and weak pulse, cold, clammy skin, dizziness, weakness or fainting (anaphylactic reaction, angioedema, shock). Other symptoms may include:
- areas of itchy, red, swollen, and cracked skin (dermatitis atopic), flushing, hot flush, blood in the white of the eye (ocular hyperaemia), redness and irritation of the eye (conjunctivitis), throat irritation, sore throat, irritation inside the nose, runny nose, sneezing, stuffy nose, sinus or throat, numbness or pins and needles sensation in the mouth (paraesthesia oral), rash in the mouth (oral mucosal eruption), asthma. These allergic reactions were reported as uncommon (may affect up to 1 in 100 people) to rare (may affect up to 1 in 1 000 people).
Additional side effects in adults and elderly Very common (may affect more than 1 in 10 people):
- Headache, muscular pain, generally feeling unwell (malaise) (1), pain at the injection site (1) Common in elderly
Common (may affect up to 1 in 10 people):
- Fever (2), shivering, reactions at the injection site: redness (erythema), hardness (induration), swelling (2) Uncommon in elderly
Uncommon (may affect up to 1 in 100 people):
- Swelling of the glands in the neck, armpit or groin (lymphadenopathy) (3), unusual weakness (3), tiredness, sleepiness (4), dizziness (4), increased sweating (hyperhidrosis) (3), joint pain (3), diarrhoea, feeling sick (nausea), reactions at the injection site: bruising, itching, warmth, discomfort (3)
Rare in elderly
(4)
Rare in adults
Rare (may affect up to 1 in 1 000 people):
- Numbness or pins and needles sensation (paraesthesia), vomiting, decreased appetite, flu-like illness
- Decrease sensitivity (hypoesthesia), abdominal pain, allergy at the injection site: only seen in adults.
- Peeled off skin (exfoliation) at the injection site: only seen in elderly. Additional side effects in children from 3 to 17 years of age Very common (may affect more than 1 in 10 people):
- Headache, muscular pain, generally feeling unwell, shivering, reactions at the injection site: pain, redness, swelling, hardness (5) (5)
Common in children from 9 to 17 years old
Common (may affect up to 1 in 10 people):
- Fever, bruising at the injection site Uncommon (may affect up to 1 in 100 people):
- Tiredness, dizziness, diarrhoea, reactions at the injection site: itching, warmth.
- Swelling of the glands in the neck, armpit or groin, abdominal pain, vomiting, restlessness, moaning, joint pain, crying: only seen in children from 3 to 8 years of age.
- Reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (thrombocytopenia): only seen in one child of 3 years of age.
- Unusual weakness, discomfort at the injection site: only seen in children from 9 to 17 years of age. Additional side effects in children from 6 to 35 months of age Very common (may affect more than 1 in 10 people):
- Irritability (6), vomiting (7), muscular pain (8), generally feeling unwell (8), fever, decrease of appetite (6), reactions at the injection site: tenderness, redness
- Unusual crying, drowsiness: only seen in children less than 24 months of age
- Headache: only seen in children from 24 months of age (6) Rare in children from 24 to 35 months old (7) Uncommon in children from 24 to 35 months old (8) Rare in children from 6 to 23 months old
Common (may affect up to 1 in 10 people):
- Diarrhoea, reactions at the injection site: hardness, bruising, swelling
- Shivering: only seen in children from 24 months of age Rare (may affect up to 1 in 1 000 people):
- Flu-like illness, reactions at the injection site: itching, rash In children from 6 months to 8 years of age who receive 2 doses, side effects are similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
Most side effects usually occurred within the 3 days following vaccination and disappeared within 1 to 3 days without treatment. The intensity of most these side effects was mild to moderate. The frequency of the following side effects is not known (cannot be estimated from the available data) in the whole population except in the population for which the side effect is listed above:
- Swelling of the glands in the neck, armpit or groin
- Numbness or pins and needles sensation (paraesthesia), pain situated on the nerve route (neuralgia) (9), fits (convulsions), neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis (9), Guillain-Barré Syndrome (9))
- Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems
- Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia). (9) Not reported in children from 6 to 35 months old
Reporting of side effects If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5.
How to store it
Vaxigrip
Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2C – 8C). Do not freeze. Keep the syringe in the outer carton in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Vaxigrip contains The active substances are: Influenza virus (inactivated, split) of the following strains*: •
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) ………………………………………………………….. 15 micrograms HA**
•
A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A) ……………………………………………………… 15 micrograms HA**
•
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)……………………………………………………………. 15 micrograms HA** Per 0.5 mL dose
- propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO (World Health Organisation) recommendations (Northern hemisphere) and EU decision for the 2025/2026 season.
The other ingredients are: a buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, water for injections. Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see Section 2). What Vaxigrip looks like and contents of the pack The vaccine, after shaking gently, is a colourless opalescent liquid. Vaxigrip is a suspension for injection presented in a pre-filled syringe of 0.5 mL, with attached needle, with separate needle or safety needle, or without needle, in box of 1 or 10. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 The Manufacturer is: Sanofi Winthrop Industrie – 1541, avenue Marcel Mérieux – 69280 Marcy l'Etoile – France Sanofi Winthrop Industrie – Voie De l'Institut – Parc Industriel d'Incarville B.P 101 – 27100 Val de Reuil – France Sanofi-Aventis Zrt. – Building Dc5 – Campona Utca 1 – Budapest XXII,1225 – Hungary This leaflet was last revised in 11/2025 <Other sources of information Latest approved information on this product is available <by scanning the QR code included in the outer carton with a smartphone or> on the following URL: https://vaxigrip-nh.info.sanofi> —————————————————————————————————————————–The following information is intended for healthcare professionals only: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. The vaccine should be allowed to reach room temperature before use. Shake before use. Inspect visually prior to administration. The vaccine should not be used if foreign particles are present in the suspension. It should not be mixed with other medicinal products in the same syringe. This vaccine is not to be injected directly into a blood vessel. See also Section 3. How to use Vaxigrip <Preparation for Administration Instructions for use of safety needle with Luer Lock pre-filled syringe:
Picture A: Safety Needle (inside case)
Picture B: Safety Needle Components (prepared for use)
Step 1: To attach the needle to the syringe, remove the hub cap to expose the hub of the needle, and gently twist the needle into the Luer Lock adapter of the syringe until slight resistance is felt.
Step 2: Pull the safety needle's case straight off. The needle is covered by the safety shield and protector.
Step 3: A: Move the safety shield away from the needle and toward the syringe barrel to the angle shown. B: Pull the protector straight off.
Step 4: After injection is complete, lock (activate) the safety shield using one of the three (3) one-handed techniques illustrated: surface, thumb or finger activation. Note: Activation is verified by an audible and/or tactile "click."
Step 5: Visually inspect the safety shield activation. The safety shield should be fully locked (activated) as shown in Figure C.
Figure D shows the safety shield is NOT fully locked (not activated).
Caution: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield.> Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Frequently asked questions about Vaxigrip suspension for injection in pre-filled syringe
How do I take Vaxigrip suspension for injection in pre-filled syringe?
Vaxigrip suspension for injection in pre-filled syringe comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Vaxigrip suspension for injection in pre-filled syringe?
The active substance in Vaxigrip suspension for injection in pre-filled syringe is influenza virus inactivated split (h1n1, h3n2-like, b/brisbane/60/2008-like, strains).
Are there equivalent medicines to Vaxigrip suspension for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Efluelda TIV-HD, suspension for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Vaxigrip suspension for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Vaxigrip suspension for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: influenza virus inactivated split (h1n1, h3n2-like, b/brisbane/60/2008-like, strains)
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Vaxigrip is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the influenza B virus type contained in the vaccine for:
- active immunisation of adults, including pregnant women, and children from 6 months of age and older,
- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections 4.4, 4.6 and 5.1).
The use of Vaxigrip should be based on official recommendations on vaccination against influenza.
4.2. Posology and method of administration
Posology
Adults: one dose of 0.5 mL.
Paediatric population
- Children from 6 months to 17 years of age: one dose of 0.5 mL.
For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.
- Infants less than 6 months of age: the safety and efficacy of Vaxigrip administration (active immunisation) have not been established. No data are available.
Regarding passive protection: one 0.5 mL dose given to pregnant women may protect infants from birth to less than 6 months of age (see Sections 4.4, 4.6 and 5.1).
Method of administration
The preferred route of administration for this vaccine is intramuscular although it can also be given subcutaneously.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults.
Precautions to be taken before handling or administering the medicinal product
For instructions on preparation of the medicinal product before administration, see Section 6.6.
4.3. Contraindications
Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Concurrent illness Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.
Precautions for use Vaxigrip should under no circumstances be administered intravascularly.
Thrombocytopenia and coagulation disorders As with other vaccines administered intramuscularly, the vaccine should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Syncope Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.
Protection Vaxigrip is intended to provide protection against those strains of influenza virus from which the vaccine is prepared.
As with any vaccine, vaccination with Vaxigrip may not protect all vaccinees.
Regarding passive protection, not all infants less than 6 months of age born to women vaccinated during pregnancy will be protected (see Section 5.1).
Immunodeficiency Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Potassium and sodium content Vaxigrip contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e. essentially 'potassium-free' and 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Vaxigrip could be given at the same time as other vaccines if needed.
Data showing that Vaxigrip can be administered concomitantly with other vaccines are available for the following vaccines: a pneumococcal polysaccharide vaccine, a tetanus, diphtheria, pertussis, polio vaccine (Tdap-IPV, Repevax), and a zoster vaccine. If Vaxigrip is given at the same time as other vaccines, separate injection sites and separate syringes should be used.
The immunological response may be reduced if the patient is undergoing immunosuppressant treatment.
4.6. Fertility, pregnancy and lactation
Pregnancy
Pregnant women are at high risk of influenza complications, including premature labour and delivery, hospitalization, and death: pregnant women should receive an influenza vaccine.
Vaxigrip can be used in all stages of pregnancy.
Larger datasets on safety of inactivated influenza vaccines are available for the second and third trimesters than for with the first trimester. Data from worldwide use of inactivated influenza vaccines, including Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated), do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
This is consistent with results observed in one clinical study where Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) were administered in pregnant women during the second or third trimester (116 exposed pregnancies and 119 live births for Vaxigrip, 230 exposed pregnancies and 231 live births for Quadrivalent Influenza Vaccine (split virion, inactivated)).
Data from four clinical studies with Vaxigrip administered in pregnant women during the second or third trimester (more than 5,000 exposed pregnancies and more than 5,000 live births followed up to approximately 6 months post-partum) did not indicate any adverse foetal, newborn, infant and maternal outcomes attributable to the vaccine.
In clinical studies conducted in South Africa and Nepal, there were no significant differences between the Vaxigrip and placebo groups with regards to foetal, newborn, infant and maternal outcomes (including miscarriage, stillbirth, premature birth, low birth weight).
In a study conducted in Mali, there were no significant differences between the Vaxigrip and control vaccine (quadrivalent meningococcal conjugate vaccine) groups with regards to prematurity rate, stillbirth rate and low birth weight/small for gestational age rate.
For additional information, see Sections 4.8 and 5.1.
Results of one reproductive study in rabbits conducted with Quadrivalent Influenza Vaccine (split virion, inactivated) (60 µg of total amount HA/dose) can be extrapolated to Vaxigrip (45 µg of total amount HA /dose): this study did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development or early post-natal development.
Breast-feeding
Vaxigrip may be used during breast-feeding.
Fertility
No fertility data are available in Humans. One animal study with Quadrivalent Influenza Vaccine (split virion, inactivated) did not indicate harmful effects on female fertility.
4.7. Effects on ability to drive and use machines
Vaxigrip has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The safety profile of Vaxigrip is based on data from 46 clinical studies in which approximately 17 900 participants from 6 months of age received Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated), and data from post-marketing surveillance.
Most of adverse reactions usually occurred within the first 3 days after vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of most these reactions was mild to moderate.
The most frequently reported adverse reaction after vaccination, in all populations including the whole group of children from 6 to 35 months of age, was injection site pain.
Tabulated list of adverse reactions
Adverse events are ranked under headings of frequency using the following convention:
Very common (≥1/10);
Common (≥1/100 to <1/10);
Uncommon (≥1/1 000 to <1/100);
Rare (≥1/10 000 to <1/1 000);
Not known (cannot be estimated from available data).
Adult and elderly
The safety profile is based on data:
- from clinical studies in more than 8 000 adults (5 064 for Vaxigrip, 3 040 for Quadrivalent Influenza Vaccine (split virion, inactivated)) and more than 5 800 elderly over 60 years of age (4 468 for Vaxigrip, 1 392 for Quadrivalent Influenza Vaccine (split virion, inactivated)),
- from worldwide post-marketing surveillance in the overall population.
In adults, the most frequently reported adverse reactions after vaccination were injection site pain (52.8%), headache (27.8%), myalgia (23.0%), malaise (19.2%).
In the elderly, the most frequently reported adverse reactions after vaccination were injection site pain (25.8%), headache (15.6%), myalgia (13.9%).
Table 1: Adverse reactions reported in adults and elderly
System Organ Class (SOC)/Adverse Reactions
Frequency
Blood and Lymphatic System Disorders
Lymphadenopathy (1)
Uncommon
Transient thrombocytopenia
Not known*
Immune System Disorders
Allergic reactions such as hypersensitivity (2), dermatitis atopic (2), urticaria (2, 3), oropharyngeal pain, asthma (1), rhinitis allergic (2), rhinorrhoea (1), conjunctivitis allergic (2), pruritus (4), hot flush (5)
Uncommon
Allergic reactions such as angioedema (2, 3), swelling face, erythema, rash, flushing (5), oral mucosal eruption (5), paraesthesia oral (5), throat irritation, dyspnoea (2, 3), sneezing, nasal obstruction (2), upper respiratory tract congestion (2), ocular hyperaemia (2), dermatitis allergic (2), pruritus generalised (2)
Rare
Allergic reactions such as rash erythematous, anaphylactic reaction, shock
Not known*
Metabolism and Nutrition Disorders
Decreased appetite
Rare
Nervous System Disorders
Headache
Very common
Dizziness (4), somnolence (4)
Uncommon
Hypoesthesia (2), paresthesia
Rare
Neuralgia, convulsions, encephalomyelitis, neuritis, Guillain Barré Syndrome
Not known*
Vascular disorders
Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases
Not known*
Gastrointestinal Disorders
Diarrhoea, nausea
Uncommon
Abdominal pain (2), vomiting
Rare
Skin and Subcutaneous System Disorders
Hyperhidrosis (1)
Uncommon
Musculoskeletal and Connective Tissue Disorders
Myalgia
Very common
Arthralgia (1)
Uncommon
General Disorders and Administration Site Conditions
Injection site pain, malaise (6)
Very common
Fever (7), shivering, injection site erythema, injection site induration, injection site swelling
Common
Asthenia (1), fatigue, injection site ecchymosis, injection site pruritus, injection site warmth, injection site discomfort
Uncommon
Flu-like symptoms, injection site exfoliation (5), injection site hypersensitivity (2)
Rare
(1) Rare in elderly
(2) Reported during clinical trials in adults
(3) Not known in elderly(4) Rare in adults (5) Reported during clinical trials in elderly(6) Common in elderly
(7) Uncommon in elderly
(*) Adverse reactions reported post-marketing after use of Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated)
Paediatric population
The safety profile is based on data:- from clinical studies in 1 247 children from 3 to 8 years of age (363 for Vaxigrip, 884 for Quadrivalent Influenza Vaccine (split virion, inactivated)) and in 725 children/adolescents from 9 to 17 years of age (296 for Vaxigrip, 429 for Quadrivalent Influenza Vaccine (split virion, inactivated)),
- from one clinical study in 1 981 children from 6 to 35 months of age (367 for Vaxigrip, 1 614 for Quadrivalent Influenza Vaccine (split virion, inactivated)),- from worldwide post-marketing surveillance in the overall population.
Depending on immunization history, children from 6 months to 8 years of age received one or two doses of Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated). Children/adolescents from 9 to 17 years of age received one dose.
In children from 6 months to 8 years of age, the safety profile was similar after the first and the second injections with a trend of lower incidence of adverse reactions after the second injection compared to the first one in children from 6 to 35 months.
In children/adolescents from 9 to 17 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (65.3%), myalgia (29.1%), headache (28.6%), malaise (20.3%), shivering (13.0%), injection site erythema (11.7%) and injection site swelling (11.4%).
In children from 3 to 8 years of age, the most frequently reported adverse reactions after any vaccination were injection site pain (59.1%), malaise (30.7%), injection site erythema (30.3%), myalgia (28.5%), headache (25.7%), injection site swelling (22.1%), injection site induration (17.6%), and shivering (11.2%).
In children from 6 to 35 months of age, the most frequently reported adverse reactions after any vaccination were injection site pain/tenderness (29.4%), fever (20.4%) and injection site erythema (17.2%).
• In subpopulation of children from 6 to 23 months of age, the most frequently reported adverse reactions after any vaccination were irritability (34.9%), crying abnormal (31.9%), appetite lost (28.9%), drowsiness (19.2%) and vomiting (17.0%).
• In subpopulation of children from 24 to 35 months of age, the most frequently reported adverse reactions after any vaccination was malaise (26.8%). myalgia (14.5%), headache (11.9%).
Table 2: Adverse reactions reported in children and adolescents from 6 months to 17 years of age
System Organ Class (SOC)/
Adverse Reactions
Frequency
Children 6-35 months of age
Children 3-8 years of age
Children and adolescents 9-17 years of age
6-23 months of age
24-35 months of age
Blood and Lymphatic System Disorders
- Lymphadenopathy
Not known*
Uncommon
Not known*
- Thrombocytopenia
Not known*
Uncommon
Not known*
Immune System Disorders
- Allergic reactions such as:
• Oropharyngeal pain
-
Uncommon
-
• Hypersensitivity
Uncommon
-
-
• Rash
-
Uncommon
Uncommon
• Urticaria
Not known*
Uncommon
Uncommon
• Pruritus
Not known*
Uncommon
Not known*
• Pruritus generalized, rash papular
Rare
-
-
• Rash erythematous, dyspnoea, anaphylactic reaction, angioedema, shock
Not known*
Not known*
Not known*
Metabolism and Nutrition Disorders
- Decreased appetite
Very common
Rare
-
-
Psychiatric Disorders
- Crying abnormal
Very common
-
-
-
- Irritability
Very common
Rare
-
-
- Restlessness
-
Uncommon
-
- Moaning
-
Uncommon
-
Nervous System Disorders
- Headache
-
Very common
Very common
Very common
- Drowsiness
Very common
-
-
-
- Dizziness
-
Uncommon
Uncommon
- Neuralgia, neuritis and Guillain Barré Syndrome
-
Not known*
Not known*
- Paraesthesia, convulsions, encephalomyelitis
Not known*
Not known*
Not known*
Vascular Disorders
- Vasculitis such as Henoch-Schonlein purpura, with transient renal involvement in certain cases
Not known*
Not known*
Not known*
Gastrointestinal Disorders
- Diarrhoea
Common
Uncommon
Uncommon
- Abdominal pain
-
Uncommon
-
- Vomiting
Very common
Uncommon
Uncommon
-
Musculoskeletal and Connective Tissue Disorders
- Myalgia
Rare
Very common
Very common
Very common
- Arthralgia
-
Uncommon
-
General Disorders and Administration Site Conditions
Injection site reactions
- Injection site pain/tenderness, injection site erythema
Very common
Very common
Very common
- Injection site swelling
Common
Very common
Very common
- Injection site induration
Common
Very common
Common
- Injection site ecchymosis
Common
Common
Common
- Injection site pruritus
Rare
Uncommon
Uncommon
- Injection site warmth
-
Uncommon
Uncommon
- Injection site discomfort
-
-
Uncommon
- Injection site rash
Rare
-
-
Systemic reactions
- Malaise
Rare
Very common
Very common
Very common
- Shivering
-
Common
Very common
Very common
- Fever
Very common
Common
Common
- Fatigue
-
Uncommon
Uncommon
- Asthenia
-
-
Uncommon
- Crying
-
Uncommon
-
- Influenza-like illness
Rare
-
(*) Adverse reactions reported post-marketing after use of Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated)
Other special populations
Although only a limited number of subjects with co-morbidities were enrolled, studies conducted in patients with co-morbidities such as renal transplant or asthmatic patients, showed no major differences in terms of safety profile of Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) in these populations.
Pregnant women
In clinical studies conducted in pregnant women in South Africa and Mali with Vaxigrip (see Sections 4.6 and 5.1), frequencies of local and systemic solicited reactions reported within 7 days following administration of the vaccine, were consistent with those reported for the adult population during clinical studies. In the study conducted in South Africa, local reactions were more frequent in the Vaxigrip group than in the placebo group in both HIV-negative and HIV-positive cohorts. There were no other significant differences in solicited reactions between Vaxigrip and placebo groups in both cohorts.
In one clinical study conducted in pregnant women in Finland with Vaxigrip and Quadrivalent Influenza Vaccine (split virion, inactivated) (see Sections 4.6 and 5.1), frequencies of reported local and systemic solicited reactions were consistent with those reported for the non-pregnant adult population during clinical studies conducted with Vaxigrip or Quadrivalent Influenza Vaccine (split virion, inactivated) even though higher for some adverse reactions (injection site pain, injection site erythema, malaise, shivering, headache, myalgia).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Cases of administration of more than the recommended dose (overdose) have been reported with Vaxigrip. When adverse reactions were reported, the information was consistent with the known safety profile of Vaxigrip described in Section 4.8.
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