A Phase 3 interventional study of sIPV+bOPV and wIPV+bOPV in Poliomyelitis, sponsored by Beijing Minhai Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 60 Days to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 3, Interventional, and Prevention
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.
Exclusion Criteria:
study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants
Biological: sIPV+bOPV
control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants
Biological: wIPV+bOPV
2+1 sequential" immunization program (sIPV-sIPV-bOPV)
2+1 sequential" immunization program (wIPV-wIPV-bOPV)
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
GMT of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
GMI of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
The seropositive rates of poliovirus type I, type II and type III neutralizing antibody
Time frame: Day 30 post full vaccination
The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64
Time frame: Day 30 post full vaccination
Incidence of adverse reactions/events
Time frame: 30 days after each dose of vaccination
Incidence of serious adverse events (SAE)
Time frame: From the first immunization to 6 months after the last immunization
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Beijing Minhai Biotechnology Co., Ltd