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OpenTrials
Completed

NCT Number: NCT00969436

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

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.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Measles Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Zoster Virus Infection Virus Diseases

Age range

9 month–10 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK Biological's investigational MMRV vaccine 208136

Biological

Subcutaneous injection

Priorix™

Biological

Subcutaneous injection

Varilrix™

Biological

Subcutaneous injection

Primary outcomes

  1. 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 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.

Secondary outcomes

  1. 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 seroconversion 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.

  2. 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).

  3. 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.

  4. 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 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.

  5. 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 was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

  6. 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

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2009
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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