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COMPLETEDPHASE3

Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

NCT00406211•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
•Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
•Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria

•Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

Locations (41)

GSK Investigational Site

Klagenfurt, Austria

GSK Investigational Site

Neufeld/Leitha, Austria

GSK Investigational Site

Salzburg, Austria

GSK Investigational Site

Villach, Austria

GSK Investigational Site

Bindlach, Bavaria, Germany

GSK Investigational Site

Marktredwitz, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Tegernsee, Bavaria, Germany

GSK Investigational Site

Tutzing, Bavaria, Germany

GSK Investigational Site

Hamburg, Hamburg, Germany

Key Dates

Start Date

July 1, 2004

Primary Completion Date

December 1, 2004

Completion Date

December 1, 2004

Last Updated

September 15, 2016

Enrollment

398

ACTUAL participants

Conditions

RubellaVaricellaMumpsMeasles

Interventions

MMRV

BIOLOGICAL

MMR (Priorix®)

BIOLOGICAL

Varicella (Varilrix®)

BIOLOGICAL

Second Dose of Varicella Vaccine in Healthy Children

NCT07475000

Varicella (Chickenpox)Varicella Immunisation

View study

RECRUITINGPHASE2

Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

NCT05422508

Varicella

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Inclusion Criteria

Exclusion Criteria

Second Dose of Varicella Vaccine in Healthy Children

Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections

Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

Correlation of Protection Against Varicella in an Exploratory Study