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

Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126997

Enrollment

1439

Registered

2005-08-05

Start date

2005-05-31

Completion date

2005-11-30

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella, Varicella

Keywords

Prophylaxis measles, mumps, rubella and chickenpox

Brief summary

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

Interventions

BIOLOGICALMeasles, Mumps, Rubella and Chickenpox (live vaccine)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

11 Months to 21 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Antibody levels after vaccination.	—

Secondary

Measure	Time frame
Safety of the study vaccines.	—

Countries

Finland, Germany, Greece, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026