Comparison Study of Immunogenicity and Safety of SIBP’s Measles, Mumps and Rubella (MMR) Vaccine versus WHO prequalified GSK Measles, Mumps and Rubella (MMR) Vaccine
- Conditions
- Measles, Mumps and Rubella MMR Vaccine
- Registration Number
- PACTR202405741158761
- Lead Sponsor
- Shanghai Institute of Biological Products Co. Ltd SIBP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1200
1. Healthy male and female child as established by medical history and clinical examination at enrollment.
2. Age: 9-11 months (inclusive) at the time of enrollment
3. Parent’s/legally acceptable representative’s (LAR) ability to read and willingness to provide written informed consent as per the
ethical and regulatory requirements of the site.
4. Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.
1. Presence of fever (defined as axillary temperature = 37.5°C) (temporary exclusion until recovery)
2. Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
3. Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
4. Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study
5. Presence of severe malnutrition (weight-for-height z-score < -3SD median)
6. Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis
7. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant’s health or is likely to result in nonconformance to the protocol.
8. Known or suspected impairment of immunological function based on medical history and physical examination.
9. Prior receipt or intent to receive measles, mumps, rubella, or yellowfever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center.
10. Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination. 11. Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period
12. Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as =2 mg/kg of body weight or =20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity<br>To demonstrate non-inferiority of SIBP MMR vaccine compared to GSK MMR vaccine when administered individually based on immunogenicity as measured at baseline and 42 days after vaccination.
- Secondary Outcome Measures
Name Time Method