Last updated: 11/07/2018 02:48:30
Comparison of GSK measles-mumps-rubella-varicella (MMRV) vaccine versus PriorixTM
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies
Timeframe: At 42 – 56 days after the second vaccination dose at week 30
Secondary outcomes:
Number of seroconverted subjects for measles, mumps, rubella and varicella antibodies
Timeframe: Approximately 42 to 56 days after the first vaccine dose at week 6
Antibody concentrations against measles, mumps, rubella and varicella viruses
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 rash
Timeframe: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
Number of subjects reporting any unsolicited adverse event
Timeframe: Within 43-day (Days 0-42) after the first and second vaccination dose
Number of subjects with serious adverse events (SAEs)
Timeframe: From the first study dose up to study end (Month 0 to Month 7.5 approximately)
Interventions:
Biological/vaccine: GSK Biological’s investigational MMRV vaccine 208136
Biological/vaccine: Priorix™
Biological/vaccine: Varilrix™
Enrollment:
450
Observational study model:
Not applicable
Primary completion date:
2011-21-02
Time perspective:
Not applicable
Clinical publications:
Sanjay L et al. (2015) Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine: a phase III, open-label, randomized trial in healthy Indian children. BMJ Open. 5(9): e007202.
Medical condition
Varicella, Rubella, Mumps, Measles
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
November 2009 to February 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
9 - 10 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-21-02
Actual study completion date
2011-21-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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