4.1. Therapeutic indications

CAPVAXIVE is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

CAPVAXIVE is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in children and adolescents 2 to less than 18 years of age who previously completed a primary paediatric pneumococcal vaccination regimen.

See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.

The use of CAPVAXIVE should be in accordance with official recommendations.

4.2. Posology and method of administration

Posology

Individuals 18 years of age and older

1 dose (0.5 mL).

Children and adolescents 2 to less than 18 years of age who previously completed a primary paediatric pneumococcal vaccination regimen

1 dose (0.5 mL).

Based on the clinical experience with other pneumococcal conjugate vaccines, if the use of 23-valent pneumococcal polysaccharide vaccine (PPSV23) is considered appropriate, CAPVAXIVE should be administered first.

The need for revaccination with a subsequent dose of CAPVAXIVE has not been established.

Paediatric population

The safety and efficacy of CAPVAXIVE in children younger than 2 years of age have not been established. No data are available.

Method of administration

CAPVAXIVE should be administered by intramuscular injection only. This vaccine should be administered preferably in the deltoid muscle of the upper arm, with care to avoid injection into or near nerves and blood vessels.

For instructions on the handling of the vaccine before administration, see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substances including diphtheria toxoid, or to any of the excipients listed in section 6.1.

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.

Anaphylaxis

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a response to the needle injection. Stress‑related reactions are temporary and resolve on their own. It is important that precautions are in place to avoid injury from fainting.

Immunocompromised individuals

Safety and immunogenicity data on CAPVAXIVE are not available for individuals in immunocompromised groups. Vaccination should be considered on an individual basis.

Based on experience with pneumococcal vaccines, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.

Protection

As with any vaccine, vaccination with CAPVAXIVE may not protect all vaccine recipients. This vaccine will only protect against Streptococcus pneumoniae serotypes included in the vaccine and to the cross-reactive serotype 15B (see sections 2 and 5.1).

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially 'sodium‑free'.

Polysorbate 20

This medicinal product contains 0.5 mg of polysorbate 20 in each dose. Polysorbates may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

Different injectable vaccines should always be administered at different injection sites.

Individuals 18 years of age and older

CAPVAXIVE can be administered concomitantly with quadrivalent influenza vaccine (split virion, inactivated). There are no data on the concomitant administration of CAPVAXIVE with vaccines other than influenza vaccines.

Children and adolescents 2 to less than 18 years of age

There are no data on the concomitant administration of CAPVAXIVE with other vaccines.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no data on the use of CAPVAXIVE in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3).

Administration of CAPVAXIVE in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and the foetus.

Breast-feeding

It is unknown whether CAPVAXIVE is excreted in human milk.

Fertility

No human data on the effect of CAPVAXIVE on fertility are available. Animal studies in female rats do not indicate harmful effects (see section 5.3).

4.7. Effects on ability to drive and use machines

CAPVAXIVE has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.

4.8. Undesirable effects

Summary of the safety profile

Individuals 18 years of age and older

The most frequently reported adverse reactions following vaccination with CAPVAXIVE in individuals 18 years of age and older were solicited. Overall, the most frequently reported adverse reactions were injection-site pain (52.9%), fatigue (25.3%), headache (17.7%), and myalgia (10.4%).

The majority of local and systemic adverse reactions for individuals who received CAPVAXIVE were mild or moderate (based on intensity or size) and of short duration (≤ 3 days); severe reactions (defined as an event that prevents normal daily activity or size ˃ 10 cm) occurred in ≤ 1.0% of adults (see Table 1).

Paediatric population (2 to less than 18 years of age)

Overall, there were no clinically meaningful differences in the safety profile observed in children and adolescents 2 to less than 18 years of age when compared to individuals 18 years of age and older.

The most frequently reported adverse reactions following vaccination with CAPVAXIVE in children and adolescents 2 to less than 18 years of age were solicited. The most frequently reported (>10%) adverse reactions were injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%). The majority of local and systemic adverse reactions for individuals who received CAPVAXIVE were mild or moderate (based on intensity or size) and of short duration (≤ 3 days). One serious adverse event (SAE) syncope (0.2%) was assessed to be related to CAPVAXIVE.

Tabulated list of adverse reactions

Unless otherwise stated the frequency categories are based on the safety of CAPVAXIVE assessed in 6 clinical studies, conducted across the Americas, Europe, Asia Pacific and Africa which included 4 914 individuals 18 years of age and older; with or without stable underlying medical conditions. Frequency data for individuals 2 to less than 18 years of age are based on one clinical study conducted in 874 children and adolescents at increased risk for pneumococcal disease who had previously completed a primary paediatric pneumococcal vaccination regimen.

Adverse reactions reported for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows:

- 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)

- Very rare (< 1/10 000)

- Not known (cannot be estimated from the available data).

Table 1: Tabulated list of adverse reactions

System Organ Class

Adverse Reactions

Frequency

Adults

Children and adolescents 2 to less than 18 Y

Blood and lymphatic system disorders

Lymphadenopathy

Uncommon

-

Immune system disorders

Hypersensitivity reaction, including bronchospasm

Rare

-

Psychiatric disorders

Irritability

-

Very common†

Nervous system disorders

Headache

Very common†

Very common†

Dizziness

Uncommon

-

Somnolence

-

Common†

Syncope

-

Uncommon

Gastrointestinal disorders

Nausea

Uncommon

-

Diarrhoea

Uncommon

-

Vomiting

Uncommon

-

Skin and subcutaneous tissue disorders

Urticaria

-

Common†

Musculoskeletal and connective tissue disorders

Myalgia

Common*†

Common†

Arthralgia

Uncommon

Common†

General disorders and administration site conditions

Injection-site pain

Very common†

Very common†

Fatigue

Very common†

Very common†

Injection-site erythema

Common*†

Very common†

Injection-site swelling

Common*†

Very common†

Pyrexia

Common†

Common†

Injection-site pruritus

Uncommon

-

Chills

Uncommon

-

Injection-site bruising

Uncommon

-

Malaise

-

Very common†

* very common in individuals 18 to 49 years of age.

† Indicates solicited adverse events. Different adverse events were solicited for adults (≥18 years of age) and paediatric participants (2 to <18 years of age). For adults, headache, myalgia, injection-site pain, fatigue, injection-site erythema, injection-site swelling and pyrexia were solicited from Day 1 through Day 5 following vaccination. For paediatric participants, all adverse events solicited in adults were also solicited, as well as irritability, somnolence, urticaria, arthralgia and malaise from Day 1 through Day 5 following vaccination.

Other special populations

Safety in individuals 65 years of age and older

A lower frequency of local injection-site reactions was observed in participants 75 years of age and older compared to participants 65 to 74 years of age. There were no clinically meaningful differences for other adverse events in participants 65 to 74 years of age and 75 years of age and older who received CAPVAXIVE.

Safety in adults living with HIV

The safety profile of CAPVAXIVE in adults living with HIV was generally comparable to the safety profile of pneumococcal 15-valent conjugate vaccine (PCV15) followed by PPSV23 (see section 5.1).

Safety in adults with increased risk for pneumococcal disease

An additional study, Protocol 008, was conducted to evaluate CAPVAXIVE in pneumococcal vaccine‑naïve adults 18 to 64 years of age with one or more prespecified chronic medical conditions known to increase the risk of pneumococcal disease (see section 5.1). The safety profile of CAPVAXIVE was generally comparable to PCV15 followed by PPSV23 and generally similar to the profile observed in the pivotal studies.

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 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

Overdose with CAPVAXIVE is unlikely due to its presentation as a pre-filled syringe.