CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 478 enrolled
Drug / intervention
GSK Biologicals'Kinrix® +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00871117
NCT00871117Phase 3Completed
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Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®

GlaxoSmithKline·interventional·Posted Mar 30, 2009·Updated Aug 22, 2018

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals'Kinrix®, Merck and Company's MMRII, and 1 other intervention for Tetanus and 2 related conditions. Completed, enrolled 478 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Acellular Pertussis, Diphtheria
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2009
Enrollment StartMar 31, 2009
Primary CompletionJan 15, 2010
Study CompletionJun 15, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.3 years ago

Interventions

GSK Biologicals'Kinrix®biological

One dose as intramuscular injection at visit 1

Merck and Company's MMRIIbiological

One dose as subcutaneous injection at visit 1

Merck and Company's Varivaxbiological

One dose as subcutaneous injection at visit 1 or at visit 2