A clinical trial to evaluate the safety and immunogenicity of HBI Measles and Rubella vaccine (Live) in two age groups of healthy male subjects.

Phase 1

Completed

• Registration Number: CTRI/2019/04/018635
• Lead Sponsor: Human Biologicals Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

1. Healthy male subjects of 12 to 49 years of age.

2. Judged to be in good health on the basis of reported medical history, physical examination and clinical judgement of the investigator.

3. Plans to remain in the study area for the entire length of the trial.

4. Subject and the LAR are literate and have understood and provided written Informed Consent.

Exclusion Criteria

1. Participation in any other clinical trial in the four weeks preceding the trial vaccination.

2. Planned participation in any other clinical trial during the present trial period.

3. Subject who has a known history of allergy to any component of the vaccine.

4. Known or suspected primary or acquired disease of the immune system.

5. Allergy immunotherapy or receiving immunosuppressive therapy.

6. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease.

7. Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. asthma, wheezing, shortness of breath).

8. Any fever with temperature >= 38.0°C (100.4oF) in last 3 days prior to the study vaccination.

9. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.

10. Any known history or suspicion of thrombocytopenia or a bleeding disorder.

11. History or suspicion of HIV, HCV or Hepatitis B.

12. History of alcoholic abuse.

13. Any history of receipt of blood products or immunoglobulins in last 3 months.

14. Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days.

15. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety 1. Solicited/unsolicited local adverse events after a single dose vaccination and during the 42 days (+7 days) follow-up period for each group. <br/ ><br> <br/ ><br>2. Solicited/unsolicited systemic adverse events after a single dose vaccination and during the 42 days (+7 days) follow-up period for each group. 3. Number of serious adverse events during the study period [42 days (+7 days)] for each group.Timepoint: Till 42-49 days after a single dose of vaccination.

Secondary Outcome Measures

Name	Time	Method
Percentage of seroconversion and seroprotection and Geometric mean titres of antibodies in each group after 42 to 49 days of vaccination with HBI Measles and Rubella Vaccine (Live).Timepoint: 42-49 days after a single dose of vaccination.