Jianing Li, United States of America

Merck & Co., Inc. Research

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Online Abstracts Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults

SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU)

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B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults

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SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU) (ID 619)

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Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults
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Abstract

Background

Streptococcus pneumoniae and influenza virus are significant causes of disease worldwide. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated safety and immunogenicity of concomitant and non-concomitant administration of V114 and quadrivalent influenza vaccine (QIV) in adults aged ≥50 years.

Methods

Overall, 1200 participants were randomized 1:1 to receive either V114 administered concomitantly with QIV (concomitant group) or V114 administered 1 month after QIV (non-concomitant group); randomization was stratified by age and history of prior pneumococcal polysaccharide vaccine. Pneumococcal serotype-specific opsonophagocytic activity (OPA) and influenza strain-specific hemagglutination inhibition (HAI) antibodies were measured prior and 30 days postvaccination. Demonstration of non-inferior immunogenicity between the concomitant and non-concomitant group required the lower bound of the 95% confidence interval of the ratio of OPA and HAI geometric mean titers (GMTs) to be ≥0.5.

Results

Proportions of participants reporting any AE, injection-site AEs, and systemic AEs were generally comparable between vaccination groups. Non-inferiority was demonstrated for all 15 pneumococcal serotypes and all 4 influenza strains between vaccination groups.

Conclusions

V114 administered concomitantly with QIV was generally well tolerated and immunologically non-inferior to non-concomitant administration, supporting co-administration of both vaccines.

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