Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00969436
First received: August 20, 2009
Last updated: September 9, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Varicella
Rubella
Mumps
Measles
Biological: GSK Biological's investigational MMRV vaccine 208136
Biological: Priorix™
Biological: Varilrix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroconversion rates for measles, mumps, rubella and varicella [ Time Frame: Approximately 42 to 56 days after the second vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion rates for measles, mumps and rubella [ Time Frame: Approximately 42 to 56 days after the first vaccine dose ] [ Designated as safety issue: No ]
  • Measles, mumps, rubella and varicella antibody titres [ Time Frame: 42 to 56 days after the first and second dose. ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: Within 4 days (Day 0 - 3) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: Within 43 days (Day 0 - 42) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited signs and symptoms [ Time Frame: Within 43 days (Day 0 - 42) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 up to 42 to 56 days after the second dose ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Subjects will receive GSK Biologicals' MMRV 208136 vaccine at 9 and 15 months
Biological: GSK Biological's investigational MMRV vaccine 208136
Subcutaneous injection
Experimental: Group 2
Subjects will receive Priorix™ at 9 months and GSK Biologicals' MMRV 208136 vaccine at 15 months
Biological: GSK Biological's investigational MMRV vaccine 208136
Subcutaneous injection
Biological: Priorix™
Subcutaneous injection
Active Comparator: Group 3
Subjects in this group will receive Priorix™ at 9 months and Priorix™ + Varilrix™ at 15 months
Biological: Priorix™
Subcutaneous injection
Biological: Varilrix™
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   9 Months to 10 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969436

Locations
India
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Chennai, India
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
Kolkata, India, 700073
GSK Investigational Site
Pune, India, 411 011
GSK Investigational Site
Pune, India
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109995
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00969436     History of Changes
Other Study ID Numbers: 109995 
Study First Received: August 20, 2009
Last Updated: September 9, 2016
Health Authority: India: Drugs Controller General of India
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Mumps
Immunogenicity
Vaccines
Safety
Rubella
Combined Vaccine
Varicella Vaccine
Children
Measles
Humans

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Mumps
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016