Trials / Completed
CompletedNCT03902054
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention · Network
- Sex
- All
- Age
- 60 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Three-dose regimen of high dosage investigational sIPV | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
| BIOLOGICAL | Three-dose regimen of medium dosage investigational sIPV | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
| BIOLOGICAL | Three-dose regimen of low dosage investigational sIPV | The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd.. |
| BIOLOGICAL | Three-dose regimen of commercialized sIPV | The control vaccine was manufactured by Chinese Academy of Medical Sciences. |
| BIOLOGICAL | Three-dose regimen of commercialized IPV | The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). |
Timeline
- Start date
- 2017-12-28
- Primary completion
- 2018-05-26
- Completion
- 2018-12-28
- First posted
- 2019-04-03
- Last updated
- 2019-04-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03902054. Inclusion in this directory is not an endorsement.