Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

Completed

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Key information

Conditions

Mumps Chickenpox DNA Virus Infections Herpesviridae Infections Infections Measles Mononegavirales Infections Morbillivirus Infections Mouth Diseases Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Varicella Zoster Virus Infection Virus Diseases

Age range

11 month–21 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bad Saulgau, Baden-Wurttemberg, Germany

About this study

Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion criteria

History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Treatment and study plan

Measles, Mumps, Rubella and Chickenpox (live vaccine)

Biological

Other names: Measles, Mumps, Rubella and Chickenpox (live vaccine)

Primary outcomes

Antibody levels after vaccination.

Secondary outcomes

Safety of the study vaccines.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life

Important dates

Study start: 2005
Study completion: 2005
First posted: Aug 5, 2005
Registry last updated: Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed