{"id":421,"date":"2024-02-14T19:21:33","date_gmt":"2024-02-14T19:21:33","guid":{"rendered":"https:\/\/www.merckvaccines.com\/capvaxive\/?page_id=421"},"modified":"2026-03-26T07:20:29","modified_gmt":"2026-03-26T07:20:29","slug":"safety-profile","status":"publish","type":"page","link":"https:\/\/www.merckvaccines.com\/capvaxive\/safety-profile\/","title":{"rendered":"Safety Profile of CAPVAXIVE\u00ae (Pneumococcal 21-valent Conjugate Vaccine)"},"content":{"rendered":"\n\n
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Safety and tolerability profile<\/h1><\/div>\n\n\n\n
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Adverse reactions in individuals 18 through 49 years of age<\/strong>
The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).

Adverse reactions in individuals 50 years of age and older<\/strong>
The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).<\/p>\n<\/div>\n\n\n\n

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The safety profile of CAPVAXIVE was generally comparable to PCV20 in Study 1<\/mark><\/strong><\/h2><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>\n\n\n\n
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Across Studies 1-3, the majority of local and systemic solicited adverse reactions were mild to moderate (based on intensity or size).

Across Studies 1-4, the proportion of individuals reporting 1 or more SAEs within 1-month postvaccination was 0.3% in individuals vaccinated with CAPVAXIVE (n=14) and 0.3% in individuals vaccinated with an active comparator (n=7). The proportion of individuals reporting 1 or more SAEs within 6 months postvaccination was 1.4% in individuals vaccinated with CAPVAXIVE (n=56) and 2.0% in individuals vaccinated with an active comparator (n=40). There were no notable patterns or imbalances between vaccine groups for SAEs. Two individuals who received CAPVAXIVE had SAEs considered related to vaccination. One individual experienced an acute allergic reaction of bronchospasm (Grade 3, required medical intervention), which occurred within 30 minutes postvaccination; one individual experienced injection-site cellulitis (Grade 4, required hospitalization) \u2028on Day 6 postvaccination.

In Study 6, no SAEs were considered to be related to CAPVAXIVE.<\/p>\n\n\n\n

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How was CAPVAXIVE studied?<\/mark><\/h2>
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Learn about the robust Phase 3 clinical trial program and the immune responses observed.<\/p>\n\n\n\n

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View clinical studies<\/a><\/div>\n<\/div>\n\n\n\n
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