A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

Summary

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

Timeline

Start

2018-12-14

Primary completion

2021-03-26

Completion

2021-03-26

Publications

• Results Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.

Drugs

Indications