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General Information
Capaxive is a Pneumococcal 21-valent Conjugate Vaccine.
Capaxive is specifically indicated for:
- active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
- active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Dosing/Administration
Capaxive is supplied as a solution for intramuscular injection. Administer a single 0.5 mL dose.
Mechanism of Action
Protection against invasive pneumococcal disease is conferred mainly by opsonophagocytic (OPA) killing of S. pneumoniae. Capaxive induces OPA against 22 S. pneumoniae serotypes. The de-O-acetylated polysaccharide from serotype 15B has a molecular structure similar to the polysaccharide from serotype 15C and induces OPA to serotype 15C. The deOAc15B also induces cross-reactive OPA against serotype 15B. An OPA titer that is predictive of protection against invasive pneumococcal disease or pneumococcal pneumonia has not been established.
Side Effects
Side effects associated with the use of Capaxive may include, but are not limited to, the following:
Individuals 18 through 49 years of age:
- injection-site pain
- fatigue
- headache
- myalgia
- injection-site erythema
- injection-site swelling
Individuals 50 years of age and older:
- injection-site pain
- fatigue
- headache
Clinical Trial Results
The FDA's accelerated approval of Capaxive was based on data that included Phase 3 clinical studies designed to evaluate its safety and immunogenicity in a variety of adult populations. These included studies of:
Vaccine-naïve adults: STRIDE-3 is a double-blind, Phase 3 study which evaluated Capaxive compared to PCV20 in individuals 18 years of age and older who had not previously received a pneumococcal conjugate vaccine. Participants 50 years of age and older were enrolled in cohort 1 (n=2,362), and participants 18 through 49 years of age were enrolled in cohort 2 (n=300). Participants were randomized to receive a single dose of either Capaxive or PCV20. Results from the study include:
- In adults 50 years of age and older (cohort 1), Capaxive was non-inferior to PCV20 for the 10 serotype polysaccharides shared with both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as assessed by serotype-specific OPA geometric mean titers (GMTs) at 1 month post-vaccination;
- Capaxive was superior to PCV20 for 10 of 11 serotype polysaccharides included in Capaxive but not in PCV20 (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMTs 1 month post-vaccination and the proportions of patients with a greater than or equal to four-fold increase in OPA from pre-vaccination to 1 month post-vaccination;
- Immune responses were observed for serotype 15C in participants receiving Capaxive but did not meet criteria for statistical significance.
- In individuals 18 through 49 years of age (cohort 2), Capaxive elicited non-inferior immune responses (immunobridged) compared to individuals 50 through 64 years of age, as assessed by serotype-specific OPA GMTs 1 month post-vaccination;
- Across both cohorts, Capaxive had a safety profile comparable to PCV20.
Co-administration of CAPVAXIVE with quadrivalent influenza vaccine (QIV) : STRIDE-5 is a randomized, double-blind, Phase 3 study which evaluated Capaxive when administered concomitantly or sequentially (30 days later) with QIV in adults 50 years of age and older (n=1,080). Results from the study include:
- For the primary immunogenicity endpoints, Capaxive administered concomitantly with QIV was non-inferior to Capaxive administered sequentially with QIV for 20 of 21 serotypes in Capaxive (as assessed by OPA GMTs at 1 month post-vaccination), as well as for three of four influenza strains in QIV (as assessed by hemagglutination inhibition (HAI) GMTs at 1 month post-vaccination);
- The rates and severity of solicited systemic adverse reactions and solicited local adverse reactions at the Capaxive injection site were similar when Capaxive was administered with or without inactivated QIV.
Vaccine-experienced adults : STRIDE-6 is a randomized descriptive Phase 3 study which evaluated Capaxive in individuals 50 years of age and older who had previously received a pneumococcal vaccine at least one year before enrollment. Participants were enrolled into one of three cohorts based on their previous pneumococcal vaccination history (cohort 1: PPSV23 [pneumococcal 23-valent polysaccharide vaccine], cohort 2: PCV13 [pneumococcal 13-valent conjugate vaccine], or cohort 3: PPSV23 followed by or preceded by PCV13, PPSV23 preceded by PCV15 [pneumococcal 15-valent conjugate vaccine], or PCV15 alone).
Participants in cohort 1 were randomized to receive Capaxive (n=231) or PCV15 (n=119), participants in cohort 2 were randomized to receive Capaxive (n=176) or PPSV23 (n=85), and participants in cohort 3 were allocated to receive Capaxive E (n=106). In each of the 3 cohorts, serotype-specific OPA GMTs and the proportion of individuals with ≥4-fold rise in OPA responses from baseline to 1-month post-vaccination were assessed. Results from the study include:
- In cohort 1, Capaxive elicited OPA responses that were comparable to PCV15 for the 6 common serotypes, and higher for the 15 unique serotypes and serotype 15B;
- In cohort 2, Capaxive elicited OPA responses comparable to PPSV23 for the 12 common serotypes and serotype 15B, and higher for the 9 unique serotypes;
- OPA responses to Capaxive were similar across the 3 cohorts of participants who previously received one or more pneumococcal vaccines;
- Capaxive had a safety profile comparable to both PCV15 and PPSV23.
Approval Date: 2024-06-01
Company Name: Merck