A clinical study to assess the safety, tolerability & immunogenicity of Measles Rubella(MR) vaccine in 4 to 5 years old healthy children.

Phase 1

Completed

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

• Registration Number: CTRI/2022/03/040874
• Lead Sponsor: Biological E Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-11-18
• Last Update Posted: 22 July 2024

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 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 <100.4ºF, pulse – 80 to 140 beats per minute, respiratory rate – 22 to 34 breaths per minute, prior to enrolment].

7. Subjects without contraindications or precautionary circumstances.

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.

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 clinically significant abnormal vital signsTimepoint: 1.during first 60 minutes of vaccine administration. <br/ ><br>2.during 14-days post vaccination period <br/ ><br>3.during the total study period up to day 42. <br/ ><br>4.during the total study period up to day 42. <br/ ><br>5. At each visit

Secondary Outcome Measures

Name	Time	Method
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.