Polio Clinical Trial
Official title:
A Phase Ib Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated
Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in
infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one
dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were
administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule.
Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination
to assess the immunogenicity in infants. Adverse events occurring within 30 days after each
dose were collected to assess the safety.
The antigen contents of type I, type II and type III polioviruses in the high-dose Sabin IPV
were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00772369 -
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
|
Phase 4 | |
| Completed |
NCT00401531 -
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
|
Phase 3 | |
| Completed |
NCT00254917 -
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
|
Phase 4 | |
| Completed |
NCT00772928 -
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
|
Phase 3 | |
| Completed |
NCT04576910 -
Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China
|
Phase 4 | |
| Not yet recruiting |
NCT06114810 -
Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV
|
Phase 4 | |
| Completed |
NCT01475539 -
Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine
|
Phase 4 | |
| Completed |
NCT01244464 -
A Study of the Safety of IMOVAX Polio™ in China
|
Phase 4 | |
| Completed |
NCT00255047 -
Safety and Immune Response of Different Pediatric Combination Vaccines.
|
Phase 3 | |
| Recruiting |
NCT05850364 -
A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
|
Phase 3 | |
| Completed |
NCT00662870 -
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
|
Phase 3 | |
| Completed |
NCT03147560 -
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
|
Phase 4 | |
| Completed |
NCT05083039 -
Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19
|
||
| Active, not recruiting |
NCT00932269 -
Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease
|
Phase 0 | |
| Completed |
NCT03922061 -
Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant
|
Phase 1 | |
| Enrolling by invitation |
NCT03818477 -
Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card
|
||
| Completed |
NCT00348387 -
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
|
Phase 3 | |
| Not yet recruiting |
NCT06460545 -
Phase IV Study of Concomitant Administration of the sIPV and HepA
|
Phase 4 | |
| Active, not recruiting |
NCT01908114 -
To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan
|
Phase 4 | |
| Completed |
NCT01389687 -
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
|
Phase 3 |