Poliomyelitis Clinical Trial
Official title:
Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
This is an open-label phase IV randomized clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally. Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliovirus vaccine (IPV) will be the only polio vaccine used for routine immunization. This clinical trial will provide poliovirus type-specific immunogenicity data on an IPV or fractional-dose IPV (fIPV)-only schedule for routine immunization, which will be important for post OPV cessation era. For fIPV, it will provide immunogenicity data on fIPV administered either intradermally (ID) or intramuscularly (IM) and allow a direct comparison of the two methods. Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04989231 -
An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses
|
||
| Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
| Recruiting |
NCT03890497 -
Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh
|
Phase 4 | |
| Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
| Completed |
NCT04693286 -
Clinical Trial of Novel OPV2 Vaccine
|
Phase 2 | |
| Completed |
NCT02847026 -
Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study
|
Phase 4 | |
| Completed |
NCT02189811 -
Polio End-game Strategies - Poliovirus Type 2 Challenge Study
|
Phase 4 | |
| Completed |
NCT01444781 -
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
|
Phase 3 | |
| Completed |
NCT01214889 -
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
|
Phase 3 | |
| Completed |
NCT00137696 -
Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine
|
N/A | |
| Completed |
NCT00879827 -
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
|
Phase 3 | |
| Completed |
NCT01457495 -
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
|
Phase 2 | |
| Completed |
NCT02853929 -
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
|
Phase 4 | |
| Completed |
NCT03614702 -
Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV
|
Phase 3 | |
| Completed |
NCT04614597 -
A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China
|
||
| Completed |
NCT03239496 -
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
|
Phase 3 | |
| Completed |
NCT04544787 -
A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates
|
Phase 2 | |
| Completed |
NCT02985320 -
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
|
Phase 1/Phase 2 | |
| Completed |
NCT02291263 -
Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine
|
Phase 3 | |
| Completed |
NCT02274285 -
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
|
Phase 3 |