NCT00871117

Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.

Detailed description

Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix, Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month 1(Group 2). All subjects in both groups to provide blood samples prior to vaccination on day 0 and at month 1 (for Group 2, blood sampling is prior to vaccination with Varivax). Duration of the study will be approximately 6 months for each subject with a safety telephone contact 6 months after vaccinations.

Conditions

• Tetanus
• Acellular Pertussis
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals'Kinrix®	One dose as intramuscular injection at visit 1
BIOLOGICAL	Merck and Company's MMRII	One dose as subcutaneous injection at visit 1
BIOLOGICAL	Merck and Company's Varivax	One dose as subcutaneous injection at visit 1 or at visit 2

Timeline

• Start date: 2009-03-31
• Primary completion: 2010-01-15
• Completion: 2010-06-15
• First posted: 2009-03-30
• Last updated: 2018-08-22
• Results posted: 2011-02-10

Locations

11 sites across 1 country: United States