Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Measles-Rubella Vaccine (Freeze-dried) Live, attenuated I.P. of BE Ltd.: BE’s live attenuated Measles-Rubella vaccine, 0.5 mL per dose to be administered subcutaneously on day 0.
Contro
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 and agrees not to allow the child / ward participate in another clinical trial at any time during the total study period; 5. Parent(s) or legally acceptable representative’s Intellectual level which allows to filling in the diaries for registering of symptoms at home; 6. Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital sign defined as body temperature 7. Subjects without contraindications or precautionary circumstances.
Exclusion criteria
Exclusion criteria: 1. History of 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 =30 days before study start; 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. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment; 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 clinically significant abnormal vital signsTimepoint: 1.during first 60 minutes of vaccine administration. 2.during 14-days post vaccination period 3.during the total study period up to day 42. 4.during the total study period up to day 42. 5. At each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentrations (GMC) of anti-Measles and anti-Rubella antibody titresTimepoint: At day 42.;Geometric Mean Fold Rise (GMFR) in anti-Measles and anti-Rubella antibody titresTimepoint: At day 42;Proportion of subjects achieving =2-fold and =4-fold increase in anti-Measles and anti-Rubella antibody titres from baselineTimepoint: At day 42;Proportion of subjects who were not seroconverted at baseline, achieving =4-fold increase in antibody titresTimepoint: At day 42;Proportion of subjects who were seroconverted at baseline, achieving =2-fold increase in antibody titresTimepoint: At day 42;Proportion of subjects with anti-Measles and anti-Rubella antibody titres above their respective seroconversion levelsTimepoint: At day 42. | — |
Countries
India
Contacts
Public ContactSubba Reddy GV
Biological E.Limited
Outcome results
None listed