None listed
Conditions
Interventions
Intervention1: GSK Biologicals investigational MMRV vaccine 208136: 2 doses at 9 and 15 months of age
Control Intervention1: Varilrix?: The vaccine will be administered concomitantly with Priorix at 1
15 months of age depending on group allocation.
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Inclusion 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
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 above 37.5°C (99.5°F) / Rectal temperature above 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rates for measles, mumps, rubella and varicella.Timepoint: Approximately 42 to 56 days after the second vaccine dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measles, mumps, rubella and varicella antibody titres.Timepoint: 42 to 56 days after the first and second dose.;Occurrence of serious adverse eventsTimepoint: From the first study dose up to study end (i.e. From Day 0 up to 42 to 56 days after the second dose);Occurrence of solicited general symptoms.Timepoint: Within 43 days (Day 0 ? 42) after vaccination.;Occurrence of solicited local symptoms.Timepoint: Within 4 days (Day 0 to 3) after vaccination.;Occurrence of unsolicited signs and symptoms.Timepoint: Within 43 days (Day 0 ? 42) after vaccination..;Seroconversion rates for measles, mumps and rubella.Timepoint: Approximately 42 to 56 days after the first vaccine dose. | — |
Countries
India
Contacts
Public ContactDr Shailesh Mehta
GlaxoSmithKline
Outcome results
None listed