Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)

Phase 4 Completed 168 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at \~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.

Timeline

Start: 2022-03-25
Primary completion: 2022-08-30
Completion: 2022-08-30

Publications

Results Guerra A, Costantino C, Martinon-Torres F, Westerholt S, Lambeth C, Chen Z, Lumley J, Marcek T, Johnson D, Wilck M. A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016). Hum Vaccin Immunother. 2024 Dec 31;20(1):2310900. doi: 10.1080/21645515.2024.2310900. Epub 2024 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pentacel	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.