A post licensure clinical trial to assess the safety and tolerability of BE’s Measles-Rubella vaccine in 9 to 12 months old healthy infants in a single dose.

Phase 4

Completed

Conditions: Health Condition 1: Z23- Encounter for immunization

Registration Number: CTRI/2019/04/018683

Lead Sponsor: Biological ELimited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

1. Healthy infants of either gender 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

1. Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis;

2. History of Measles, MR or MMR vaccination(s)

3. Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.

4. Acute or chronic illness or major congenital defects;

5. Exposure to measles and rubella =30 days before study start;

6. Use of blood products within 3 months before the vaccination;

7. Use of any unregistered vaccine type within 30 days before the study vaccination ;

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 criteria, which in the opinion of the Investigator, suggests that the child would not be compliant with the requirements of the study protocol.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber and percentage of: <br/ ><br>1.solicited local and systemic adverse events (AEs). <br/ ><br>2. solicited local and systemic AEs <br/ ><br>3. unsolicited AEs <br/ ><br>4. Rate of SAEs and medically attended AEs <br/ ><br>5. Number and percentage of subjects with clinically significant abnormal vital signs (Pulse, Axillary body temperature and Respiratory rate)Timepoint: 1. During first 30 minutes of post-vaccine administration. <br/ ><br>2. during subsequent 14-day (Day 0-13) post vaccination period, captured through subject diary. <br/ ><br>3. up to day 42 after the vaccination. <br/ ><br>4. until day 42 after the vaccination. <br/ ><br>5. at each visit.

Secondary Outcome Measures