Loading clinical trials...

COMPLETEDPHASE3

A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

NCT06752174•Beijing Minhai Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.

Detailed Description

A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
•2. Infant's legal guardians agree to sign the informed consent forms voluntarily;
•3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
•4. Armpit temperature ≤ 37.0 ℃

Exclusion Criteria

•1. Preterm birth (delivery before the 37th week of pregnancy).
•2. Previous vaccination against polio.
•3. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
•4. History of polio.
•5. History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
•6. History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
•7. Individuals with immunodeficiency or receiving immunosuppression therapy.
•8. Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
•9. Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
•10. Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
+5 more criteria

Locations (1)

Shandong Provincial Center for Diseases Control and Prevention

Jinan, Shandong, China

Key Dates

Start Date

March 8, 2023

Primary Completion Date

April 12, 2024

Completion Date

April 12, 2024

Last Updated

December 30, 2024

Enrollment

300

ACTUAL participants

Conditions

Poliomyelitis

Interventions

sIPV+bOPV

BIOLOGICAL

wIPV+bOPV

BIOLOGICAL

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

NCT05644184

Poliomyelitis

View study

RECRUITINGPHASE2/PHASE3

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

NCT06947499

DiphtheriaTetanus+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

Inclusion Criteria

Exclusion Criteria

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

Booster Dose of sIPV Co-administered With MMR and HepA-I.

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants