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.
Cont
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male or female children, aged between 4-5 years at the time of first dose administration; 2.Parent or legally acceptable representative capable to understand and willing to provide written informed consent including permission for audio-visual recording of the consent process; 3.Willing to strictly follow the study protocol requirements; 4.Understands the impossibility of participating in another clinical trial during the time of participation in the study; 5.Parent(s) or legally acceptable representativeâ??s Intellectual level which allows to filling in the diaries for registering of symptoms at home; 6.Lab examination at screening period within the acceptable limits as judged by the investigator, determined by the laboratory reports; 7.Subjects without contraindications or precautionary circumstances.
Exclusion criteria
Exclusion criteria: 1.Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis; 2.Family or personal history of any hypersensitivity reactions to Measles, MR or MMR vaccinations; 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.Positive HIV, HBV and HCV tests at screening examination; 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.Number and percentage of solicited local and systemic adverse reactions 2.Number and percentage of solicited local and systemic adverse events (AEs) 3.Number and percentage of solicited and unsolicited adverse events (AEs) 4.Rate of SAEs and medically attended AEs 5.Number and percentage of any clinically significant abnormal laboratory parameters 6.Number and percentage of clinically significant abnormal vital signsTimepoint: 1.During first 6 hours of vaccine administration 2.During 7-day (Day 0-6) post vaccination period, captured through subject diary 3.During the total period up to day 30 4.Until day 30 after the first vaccination 5.As judged by the Investigator at the study site 6.At each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Biological E.Limited
Outcome results
None listed