A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

NCT03620162 ↗

Phase 3 Completed 900 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindPrevention

Summary

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Timeline

Start: 2018-10-18
Primary completion: 2020-12-14
Completion: 2020-12-14

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “(V114-027/PNEU-DIRECTION [NCT03620162]). The study demonstrated generally comparable immune responses” merck.com ↗

Publications

Results Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prevnar 13	Vaccine	0.5 ml	Intramuscular
Subject	V114	Vaccine	0.5 ml	Intramuscular
Background	HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN	Vaccine	—	Intramuscular
Background	HEPLISAV-B	Vaccine	—	Intramuscular
Background	M-M-R II	Vaccine	—	Subcutaneous
Background	Pentacel	Vaccine	—	Intramuscular
Background	RotaTeq	Vaccine	—	Oral
Background	Varivax	Vaccine	—	Subcutaneous