NCT05289271

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

A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 11 Months – 13 Months
• Healthy volunteers: Accepted

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™.

Conditions

• Vaccines, Combined
• Hexavalent Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Vaxelis™	Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.

Timeline

• Start date: 2022-03-25
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2022-03-21
• Last updated: 2024-07-29
• Results posted: 2023-09-06

Locations

13 sites across 3 countries: Germany, Italy, Spain

Regulatory

• FDA-regulated drug study