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MMRV Vaccines for Measles, Mumps, Rubella, and Chickenpox

(MMRVNS 20-002 Trial)

Not yet recruiting at 59 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.

The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).

The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Are You a Good Fit for This Trial?

This trial is for healthy children aged 4 to 6 years who have already received one dose of a measles, mumps, rubella, and/or chickenpox (varicella) vaccine. Children must be generally healthy to participate.

Inclusion Criteria

Healthy participants as established by medical history and clinical examination at screening
I received my first MMR vaccine when I was 1 year old.
I have received 3 or 4 doses of a DTP vaccine as recommended locally.
See 5 more

Exclusion Criteria

Major congenital defects as assessed by the investigator
Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study
I have a condition that weakens my immune system.
See 20 more

What Are the Treatments Tested in This Trial?

Interventions

  • DTaP-IPV vaccine
  • MMRVNS vaccine
  • MMRV vaccine

Trial Overview

The study compares the immune response and safety of three batches of an investigational MMRVNS vaccine with the licensed MMRV vaccine. Both are given as a second dose, sometimes together with a DTaP-IPV (Kinrix) shot.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: MMRVNS_Lot 3 groupExperimental Treatment2 Interventions
Group II: MMRVNS_Lot 2 groupExperimental Treatment2 Interventions
Group III: MMRVNS_Lot 1 groupExperimental Treatment2 Interventions
Group IV: MMRV groupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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