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Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

NCT00892775•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
•Free of obvious healthy problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose.
•Previous vaccination against measles, mumps, rubella and/or varicella.
•History of measles, mumps, rubella and/or varicella/zoster diseases.
•Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
+8 more criteria

Locations (6)

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taipei, Taiwan

Key Dates

Start Date

June 3, 2009

Primary Completion Date

September 17, 2010

Completion Date

December 13, 2010

Last Updated

November 15, 2019

Enrollment

501

ACTUAL participants

Conditions

MeaslesVaricellaMumpsRubella

Interventions

Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine)

BIOLOGICAL

GSK Biologicals' 208136, new formulation

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

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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: November 15, 2019Data 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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Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

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