Approval Probability
TA Base Rate
Adjusted LOA
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Sabin Strain Inactivated Poliovirus Vaccine · 1 trial · 2 indications
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines
Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination
| Arm | Type | Description |
|---|---|---|
| group C1 | EXPERIMENTAL | Co-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360) |
| group C2 | EXPERIMENTAL | Co-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old |
| group S1 | EXPERIMENTAL | Administration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old |
| group S2 | EXPERIMENTAL | Administration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old |
| Name | Type | Description |
|---|---|---|
| Sabin Strain Inactivated Poliovirus Vaccine | BIOLOGICAL | Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks old, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks old, and receive routine infant vaccines at 8,12,16 weeks old. Participant s in group S2 will receive routine infant vaccines at 6,10,14 weeks old, and receive sIPV at 8,12, 16 weeks old. |
Inclusion Criteria: 1\) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination records after birth; 4) Negative results in SARS-CoV-2 rapid antigen testing, within 24 hours...
Sabin Strain Inactivated Poliovirus Vaccine is used for the prevention of poliomyelitis, a viral disease that can cause paralysis. It is an inactivated polio vaccine being developed for use in children as young as 42 days old, based on a Phase 3 clinical trial.
Sabin Strain Inactivated Poliovirus Vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker SVA. The company is conducting clinical trials for this vaccine to prevent poliomyelitis.
Sabin Strain Inactivated Poliovirus Vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use. The Phase 3 trial has been completed, and the vaccine is being studied for the prevention of poliomyelitis.
Sabin Strain Inactivated Poliovirus Vaccine has one completed Phase 3 clinical trial registered as NCT05850364. This was a multi-center, open-label, randomized, controlled trial involving 1,442 participants in Bangladesh and Pakistan, studying the vaccine for poliomyelitis in healthy volunteers.
Yes, Sabin Strain Inactivated Poliovirus Vaccine is also referred to as the sIPV vaccine. The clinical trial NCT05850364, which studied this vaccine, is titled 'A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine'.