Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course
1 other identifier
interventional
450
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedStudy Start
First participant enrolled
November 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2011
CompletedResults Posted
Study results publicly available
September 25, 2017
CompletedJune 8, 2018
May 1, 2017
1.3 years
August 20, 2009
May 4, 2017
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies
Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
At 42 - 56 days after the second vaccination dose at week 30
Secondary Outcomes (8)
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies
Approximately 42 to 56 days after the first vaccine dose at week 6
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses
At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
Number of Subjects Reporting Any, Grade 3 and Related Fever
During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
- +3 more secondary outcomes
Study Arms (3)
Priorix-Tetra Group
EXPERIMENTALSubjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
Priorix/ Priorix-Tetra Group
EXPERIMENTALSubjects 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.
Control Group
ACTIVE COMPARATORSubjects 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.
Interventions
Subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (6)
GSK Investigational Site
Bangalore, 560034, India
GSK Investigational Site
Chennai, India
GSK Investigational Site
Goa, 403202, India
GSK Investigational Site
Kolkata, 700073, India
GSK Investigational Site
Pune, 411 011, India
GSK Investigational Site
Pune, India
Related Publications (1)
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.
PMID: 26362659DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
September 1, 2009
Study Start
November 9, 2009
Primary Completion
February 21, 2011
Study Completion
February 21, 2011
Last Updated
June 8, 2018
Results First Posted
September 25, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.