Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Measles-Rubella (MR) Vaccine, Live, Attenuated (Freeze-dried) of BE Ltd.: BEâ??s live attenuated measles-rubella vaccine 0.5 mL per dose to be administered subcutaneously on day 0.
Subj
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male or female infants between 9-12 months of age at the time of first vaccination; 2.Infants free of obvious health problems as established by medical history and physical examination before entering the study. 3.Parent or LAR willing to provide written informed consent. 4.Willing to strictly follow the study protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis; 2.Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components. 3.Acute or chronic illness or major congenital defects; 4.Exposure to measles and rubella 5.Use of blood products within 3 months before the vaccination; 6.Use of any vaccine type within 30 days before the vaccination of the study; 7.Any confirmed or suspected condition wherein the child is immunocompromised or receiving immunosuppressive medication; 8.Use of any kind of investigational medication within 3 months before the study vaccination; 9.Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause); 10.A history of neurologic disorders or seizures; 11.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg). 12.Any criteria, which in the opinion of the Investigator, suggests that the child would not be compliant with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects seroconverted. 2.Geometric mean concentrations. 3.Proportion of subjects who were not seroconverted at baseline, achieving â?¥4-fold increase in antibody titres 4.Proportion of subjects who were seroconverted at baseline, achieving â?¥2-fold increase in antibody titres. 5.Non-inferiority in terms of difference in proportion of subjects seroconverted.Timepoint: 1.At day 42 2.At day 42 3.At day 42 4.At day 42 5.At day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of: 1.solicited local and systemic adverse events (AEs) 2.solicited local and systemic AEs. 3.unsolicited AEs. 4.Rate of SAEs and medically attended AEs. 5.Number and percentage of clinically significant abnormal vital signs (Pulse, Axillary body temperature and Respiratory rate) for any clinically significant changes.Timepoint: 1.during first 1 hour of post-vaccine administration. 2.during 7-day (Day 0-6) post vaccination period. 3.up to day 42 after the first vaccination. 4.until day 42 after the first vaccination. 5.At each visit. | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Biological E.Limited
Outcome results
None listed