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

NCT ID: NCT00892775

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-03
• Study Completion Date: 2010-12-13

Brief 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.

Conditions

Measles; Varicella; Mumps; Rubella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Priorix-Tetra new WS Group

Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.

Group Type: EXPERIMENTAL

GSK Biologicals' 208136, new formulation

Intervention Type: BIOLOGICAL

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Priorix-Tetra current WS Group

Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Interventions

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

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Intervention Type: BIOLOGICAL

GSK Biologicals' 208136, new formulation

Vaccine will be administered subcutaneously in the left upper arm (deltoid region)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Rectal temperature ≥38°C or axillary temperature >=37.5°C at the time of vaccination.
• Residence in the same household as a high risk person e.g.:
• New-born infants (0-4 weeks of age)
• Pregnant women who have a negative history of chickenpox
• Persons with known immunodeficiency

• Minimum Eligible Age: 11 Months
• Maximum Eligible Age: 21 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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

Countries

Singapore; Taiwan

References

Huang LM, Lee BW, Chan PC, Povey M, Henry O. Immunogenicity and safety of combined measles-mumps-rubella-varicella vaccine using new measles and rubella working seeds in healthy children in Taiwan and Singapore: a phase II, randomized, double-blind trial. Hum Vaccin Immunother. 2013 Jun;9(6):1308-15. doi: 10.4161/hv.24035. Epub 2013 Feb 20.

Reference Type: BACKGROUND

PMID: 23425607 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2011-005881-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108760

Identifier Type: -

Identifier Source: org_study_id