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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969436
First Posted: September 1, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: None (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:
  • Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies [ Time Frame: At 42 - 56 days after the second vaccination dose at week 30 ]
    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 serocoversion 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.


Secondary Outcome Measures:
  • Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies [ Time Frame: Approximately 42 to 56 days after the first vaccine dose at week 6 ]
    Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

  • Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses [ Time Frame: At 42 - 56 days after the first (at week 6) and second (at week 30) vaccination dose ]
    Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs)

  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose (dose 1 and dose 2) ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2) ]
    Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 (G3) meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related (Rel) = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects Reporting Any, Grade 3 and Related Fever [ Time Frame: During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2) ]
    Any fever was defined as fever ≥ 38.0°C and grade 3 fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

  • Number of Subjects Reporting Any, Grade 3 and Related Rash [ Time Frame: During the 43-day (Days 0-42) post-vaccination period following each dose (dose 1 and dose 2) ]
    Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination

  • Number of Subjects Reporting Any Unsolicited Adverse Event [ Time Frame: Within 43-day (Days 0-42) after the first and second vaccination dose ]
    An unsolicited Adverse Event (AE) covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From the first study dose up to study end (Month 0 to Month 7.5 approximately) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 450
Actual Study Start Date: November 9, 2009
Study Completion Date: February 21, 2011
Primary Completion Date: February 21, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: GSK Biological's investigational MMRV vaccine 208136
Subcutaneous injection
Experimental: 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.
Biological: GSK Biological's investigational MMRV vaccine 208136
Subcutaneous injection
Biological: Priorix™
Subcutaneous injection
Active Comparator: 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.
Biological: Priorix™
Subcutaneous injection
Biological: Varilrix™
Subcutaneous injection

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   9 Months to 10 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 20, 2009
First Posted: September 1, 2009
Results First Submitted: May 4, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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