Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009, China
NCT Number: NCT03902054
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
Looking for future studies?
Notify Me60 day–90 day
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, 210009, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Time frame: 28~42 days
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Time frame: 28~42 days
GMT of each group 28~42 days after three-dose regimen.
Time frame: 28~42 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 7 days
Solicited AEs occurred within 7 days after each injection will be collected.
Time frame: 30 days
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
SAEs occurred within 30 days after each injection will be collected.
Jiangsu Province Centers for Disease Control and Prevention
Network
A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06162104
Central Nervous System Diseases, Central Nervous System Infections
Istanbul, Bahcelievler, Turkey (Türkiye)
View Trial DetailsNCT02341950
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Ann Arbor, Michigan, United States
View Trial DetailsNCT06926270
Central Nervous System Diseases, Central Nervous System Infections
Izmir, BORNOVA, Turkey (Türkiye)
View Trial DetailsNCT03653390
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Seattle, Washington, United States
View Trial Details