The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains(Sabin IPV)

NCT ID: NCT01510366

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-09-30

Brief Summary

Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).

Detailed Description

The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.

Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.

This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Cohort 1

Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections.

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strains)

Intervention Type: BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.

Cohort 2:

Inactivated Poliomyelitis Vaccine (Salk strains) 3 x 0.5ml intramuscular injections.

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Salk strains)

Intervention Type: BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.

Interventions

Inactivated Poliomyelitis Vaccine (Sabin strains)

Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.

Intervention Type: BIOLOGICAL

Inactivated Poliomyelitis Vaccine (Salk strains)

Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.

Intervention Type: BIOLOGICAL

Other Intervention Names

Sabin IPV; Salk IPV or cIPV

Eligibility Criteria

Inclusion Criteria

• Males and females, age from 60 days to 90 days;
• Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
• Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
• Axillary temperature ≤37℃.

Exclusion Criteria

• Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
• Low platelet or bleeding disorder do not allow vaccination into the muscle;
• Have damaged or lower immunological function;
• Received blood, plasma or immunoglobulin treatment since birth;
• Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
• Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

• Have serious anaphylaxis or high fever, convulsion during first dose;
• Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
• Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
• Vaccinated with any other vaccine（except DTP）;
• Stop observation determined by investigator owing to occurring serious adverse event.

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

National Institute for the Control of Pharmaceutical and Biological Products, China

OTHER

Sponsor Role: collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoyang Liao, PH.D

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Biology, Chinese Academy of Medical Sciences

Yanping Li, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Changgui Li, PHD

Role: PRINCIPAL_INVESTIGATOR

National Institute for the Control of Pharmaceutical and Biological Products, China

Locations

Pingle Center for Disease Prevention and Control

Guilin, Guangxi, China

Bingyang Center for Disease Prevention and Control

Nanning, Guangxi, China

Countries

China

References

Ma L, Ying Z, Cai W, Wang J, Zhou J, Yang H, Gao J, Zhao Z, Liu J, Ouyang S, Song S, Shen F, Zhao R, Xu L, Dai X, Wu Y, Li W, Li C, Liao G. Immune persistence of an inactivated poliovirus vaccine derived from the Sabin strain: a 10-year follow-up of a phase 3 study. EClinicalMedicine. 2023 Sep 14;64:102151. doi: 10.1016/j.eclinm.2023.102151. eCollection 2023 Oct.

Reference Type: DERIVED

PMID: 37745024 (View on PubMed)

Other Identifiers

2011L01484

Identifier Type: OTHER

Identifier Source: secondary_id

IMBCAMS-03

Identifier Type: -

Identifier Source: org_study_id