Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

NCT ID: NCT00969436

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-09
• Study Completion Date: 2011-02-21

Brief Summary

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.

Conditions

Varicella; Rubella; Mumps; Measles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Priorix-Tetra Group

Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.

Group Type: EXPERIMENTAL

GSK Biological's investigational MMRV vaccine 208136

Intervention Type: BIOLOGICAL

Subcutaneous injection

Priorix/ Priorix-Tetra Group

Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.

Group Type: EXPERIMENTAL

GSK Biological's investigational MMRV vaccine 208136

Intervention Type: BIOLOGICAL

Subcutaneous injection

Priorix™

Intervention Type: BIOLOGICAL

Subcutaneous injection

Control Group

Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.

Group Type: ACTIVE_COMPARATOR

Priorix™

Intervention Type: BIOLOGICAL

Subcutaneous injection

Varilrix™

Intervention Type: BIOLOGICAL

Subcutaneous injection

Interventions

GSK Biological's investigational MMRV vaccine 208136

Subcutaneous injection

Intervention Type: BIOLOGICAL

Priorix™

Subcutaneous injection

Intervention Type: BIOLOGICAL

Varilrix™

Subcutaneous injection

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 should be enrolled in the study.
• Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination.
• Written informed consent obtained from the the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine .
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product.
• Previous vaccination against measles, mumps, rubella and varicella.
• History of measles, mumps, rubella and/or varicella diseases.
• Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Axillary temperature > 37.5°C (99.5°F) / Rectal temperature > 38°C (100.4°F).
• Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
• Presence of a susceptible high-risk person in the same household during the study period.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 10 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

Bangalore, , India

GSK Investigational Site

Chennai, , India

GSK Investigational Site

Goa, , India

GSK Investigational Site

Kolkata, , India

GSK Investigational Site

Pune, , India

GSK Investigational Site

Pune, , India

Countries

India

References

Lalwani S, Chatterjee S, Balasubramanian S, Bavdekar A, Mehta S, Datta S, Povey M, Henry O. Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial. BMJ Open. 2015 Sep 11;5(9):e007202. doi: 10.1136/bmjopen-2014-007202.

Reference Type: DERIVED

PMID: 26362659 (View on PubMed)

Study Documents

Document Type: Study Protocol

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: Dataset Specification

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

Document Type: Annotated Case Report Form

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

View Document

Document Type: Clinical Study Report

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

Related Links

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Other Identifiers

109995

Identifier Type: -

Identifier Source: org_study_id