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

NCT05289271 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-07-29

Study results available
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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

BIOLOGICAL

Vaxelis™

Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2022-08-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289271 on ClinicalTrials.gov