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Sabin Strain Inactivated Poliovirus Vaccine

Phase 3

Poliomyelitis | Vaccine | Infectious Disease |Sinovac Biotech, Ltd|Trials Updated: Dec 18, 2025

Sabin Strain Inactivated Poliovirus Vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment1,442

FDA Designations

No designations recorded

Sabin Strain Inactivated Poliovirus Vaccine clinical trials

Sabin Strain Inactivated Poliovirus Vaccine · 1 trial · 2 indications

Phase 3 1
NCT05850364A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV VaccinePoliomyelitis
COMPLETED1,442 Analytics
PHASE3COMPLETED
A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
PoliomyelitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines
28 days

Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines

To evaluate the safety in terms of ARs (Vaccine-related AEs)
7 days

Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination

Secondary Endpoints

To evaluate non-inferiority of immune response to diphtheria and tetanus antigens, when routine vaccines are administered concomitantly with sIPV
28 days
To evaluate non-inferiority of immune response to acellular pertussis antigens, when routine vaccines are administered concomitantly with sIPV
28 days
To evaluate the immunogenicity against hepatitis B and Hib, when routine vaccines are administered concomitantly with sIPV
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
group C1EXPERIMENTALCo-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360)
group C2EXPERIMENTALCo-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old
group S1EXPERIMENTALAdministration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old
group S2EXPERIMENTALAdministration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old

Interventions

NameTypeDescription
Sabin Strain Inactivated Poliovirus VaccineBIOLOGICALTotally 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.
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Eligibility Criteria

Age Range42 Days to 47 Days
SexALL
Healthy VolunteersYes
Study Sites3

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...

Countries:BangladeshPakistan
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Frequently asked questions about Sabin Strain Inactivated Poliovirus Vaccine

What is Sabin Strain Inactivated Poliovirus Vaccine?

Sabin Strain Inactivated Poliovirus Vaccine, or sIPV, is an investigational vaccine developed by Sinovac Biotech, Ltd for the prevention of poliomyelitis. It is a vaccine candidate designed to protect against polio, a disease caused by poliovirus infection. It is being studied in clinical trials rather than being an approved product.

What is Sabin Strain Inactivated Poliovirus Vaccine used for?

Sabin Strain Inactivated Poliovirus Vaccine is being developed for the prevention of poliomyelitis, also known as polio. Its intended use is immunization against poliovirus infection. The vaccine is studied in healthy volunteers, including infants from 42 days of age, in countries such as Bangladesh and Pakistan.

Who is developing Sabin Strain Inactivated Poliovirus Vaccine?

Sabin Strain Inactivated Poliovirus Vaccine is being developed by Sinovac Biotech, Ltd, which trades under the ticker SVA. Sinovac is the sponsor of the clinical program for this polio vaccine candidate.

What phase is Sabin Strain Inactivated Poliovirus Vaccine in?

Sabin Strain Inactivated Poliovirus Vaccine has completed a Phase 3 clinical trial. It is an investigational vaccine and is not described as approved. The Phase 3 study, NCT05850364, was a multi-center, open-labelled, randomized, controlled, extended Phase 3 trial that has been completed.

What clinical trials is Sabin Strain Inactivated Poliovirus Vaccine in?

Sabin Strain Inactivated Poliovirus Vaccine has been studied in one clinical trial, NCT05850364, titled a multi-center, open-labelled, randomized, controlled, extended Phase 3 clinical trial of sIPV vaccine. The trial enrolled 1,442 participants, was conducted in Bangladesh and Pakistan, and has been completed.

Is Sabin Strain Inactivated Poliovirus Vaccine the same as sIPV?

Yes, Sabin Strain Inactivated Poliovirus Vaccine is also known as sIPV. The abbreviation sIPV appears in the title of its Phase 3 clinical trial, NCT05850364, which evaluated the sIPV vaccine. Readers searching for sIPV are referring to the same Sinovac polio vaccine candidate.