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A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

NCT05084508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-02-28

Study results available
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Summary

The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.

Conditions

  • Chickenpox

Interventions

BIOLOGICAL

Investigational varicella vaccine low potency

1 dose of a low-potency investigational varicella vaccine administered subcutaneously.

BIOLOGICAL

Investigational varicella vaccine medium potency

1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.

BIOLOGICAL

Investigational varicella vaccine high potency

1 dose of a high-potency investigational varicella vaccine administered subcutaneously.

BIOLOGICAL

Licensed varicella vaccine Lot 1

1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.

BIOLOGICAL

Licensed varicella vaccine Lot 2

1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.

BIOLOGICAL

Measles, mumps, and rubella vaccine

1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.

BIOLOGICAL

Hepatitis A vaccine

1 dose of a hepatitis A vaccine administered intramuscularly.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2024-02-09
Completion
2024-06-13
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Poland
  • Puerto Rico
  • Taiwan
  • United Kingdom

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 NCT05084508 on ClinicalTrials.gov