Clinical trial NCT00969436: Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Rubella
Mumps
Measles
Keywords: Mumps
Immunogenicity
Vaccines
Safety
Rubella
Combined Vaccine
Varicella Vaccine
Children
Measles
Humans
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 450
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Number of Subjects Reporting Any Unsolicited Adverse Event
timeFrame: Within 43-day (Days 0-42) after the first and second vaccination dose
measure: 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)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Goa
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.