A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9-11 Months of Age.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 11 months
Healthy Volunteers: t
View:

• Healthy male and female child as established by medical history and clinical examination at enrollment.

• Age: 9-11 months (inclusive) at the time of enrollment

• 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.

• 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.

Locations
Other Locations
Kenya
Victoria Biomedical Research Institute(VIBRI)
RECRUITING
Kisumu
Contact Information
Primary
Dandan Chen, Master
ddchen.sh@sinopharm.com
86-021-62800991
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2025-06-20
Participants
Target number of participants: 1200
Treatments
Experimental: SIBP MMR vaccine group
Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43.
Active_comparator: GSK MMR vaccine group
Received a single dose of GSK MMR vaccine alone at D1.
Experimental: Joint vaccination group
Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1.
Sponsors
Leads: Shanghai Institute Of Biological Products
Collaborators: Victoria Biomedical Research Institute

This content was sourced from clinicaltrials.gov