A clinical trial to assess the safety and protective efficacy of Biological Es Measles-Rubella Vaccine in 9-12 months old Infants in India.

Phase 2/3

Completed

• Conditions: Encounter for immunization,; For active immunization for the prevention of disease caused by Measles and Rubella viruses

• Registration Number: CTRI/2016/07/007109
• Lead Sponsor: Biological ELimited

Brief Summary

Thisis a randomized comparative, multicentre phase-II/III study to assess safetyand Immunogenicity of Biological E.’s Measles-Rubella Vaccine. The safety andimmunogenicity of this vaccine will be compared with licensed SIIL’s MR-Vacâ„¢vaccine. 

Therewill be two treatment groups viz., subjects receiving Biological E.’s MRvaccine (Group-1) and subjects receiving SIIL’s licensed MR-Vac® vaccine(Group-2). The target population for this study would be healthy male andfemale infants between 9-12 months of age at the time of first vaccination.all enrolled subjectswould be followed up for a period of 42 days after a single primary dose of MRvaccine administration.



Only optimal quantity of venous blood sample approximately3.5 mL for Immunologicalassay tests will be drawn twice during the study period, once atscreening (visit-1) and again 42 days (Visit-3) after the singledose.Vital signs will be recorded at all specified visits.

In syncwith the WHO mandate and Indian commitment for introduction of MR or MMRvaccine into the national routine immunization programme,Biological E.initiated MR vaccine development.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-29
• Study Completion: 2017-07-03
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 1.Healthy male or female infants 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.Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
• 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.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
• 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.Proportion of subjects seroconverted.	1.At day 42 | 2.At day 42 | 3.At day 42 | 4.At day 42 | 5.At day 42
2.Geometric mean concentrations.	1.At day 42 | 2.At day 42 | 3.At day 42 | 4.At day 42 | 5.At day 42
4.Proportion of subjects who were seroconverted at baseline, achieving ≥2-fold increase in antibody titres.	1.At day 42 | 2.At day 42 | 3.At day 42 | 4.At day 42 | 5.At day 42
5.Non-inferiority in terms of difference in proportion of subjects seroconverted.	1.At day 42 | 2.At day 42 | 3.At day 42 | 4.At day 42 | 5.At day 42
3.Proportion of subjects who were not seroconverted at baseline, achieving ≥4-fold increase in antibody titres	1.At day 42 | 2.At day 42 | 3.At day 42 | 4.At day 42 | 5.At day 42

Secondary Outcome Measures

Name	Time	Method
Number and percentage of:	1.solicited local and systemic adverse events (AEs)

Trial Locations

Locations (6)

Cheluvamba Hospital; 🇮🇳 Mysore, KARNATAKA, India

Institute of Child Health; 🇮🇳 Kolkata, WEST BENGAL, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

KPC Medical college; 🇮🇳 Kolkata, WEST BENGAL, India

Postgraduate Institute of Medical Education & Research (PGIME&R); 🇮🇳 Chandigarh, CHANDIGARH, India

Sant Dnyaneshwar Medical Education & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Cheluvamba Hospital

🇮🇳Mysore, KARNATAKA, India

Dr B Krishna Murthy

Principal investigator

09448057007

bkm876@gmail.com