A phase-I study to evaluate the safety and tolerability of Measles Rubella(MR) vaccine in 4-5 years old healthy children in a single dose schedule.

Phase 1

Completed

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2015/11/006375
• Lead Sponsor: Biological E Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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

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 <=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.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Number and percentage of solicited local and systemic adverse reactions <br/ ><br>2.Number and percentage of solicited local and systemic adverse events (AEs) <br/ ><br>3.Number and percentage of solicited and unsolicited adverse events (AEs) <br/ ><br>4.Rate of SAEs and medically attended AEs <br/ ><br>5.Number and percentage of any clinically significant abnormal laboratory parameters <br/ ><br>6.Number and percentage of clinically significant abnormal vital signsTimepoint: 1.During first 6 hours of vaccine administration <br/ ><br>2.During 7-day (Day 0-6) post vaccination period, captured through subject diary <br/ ><br>3.During the total period up to day 30 <br/ ><br>4.Until day 30 after the first vaccination <br/ ><br>5.As judged by the Investigator at the study site <br/ ><br>6.At each visit

Secondary Outcome Measures

Name	Time	Method
oneTimepoint: None