Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

NCT04224519 | Completed Phase 4 DMC

• 1 other identifier: 20171217
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• Seroconversion rate of neutralizing antibody

  Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.

  1 month after primary immunization

• Local and systemic adverse reactions

  Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.

  Within 1 month after primary immunization

Secondary Outcomes (1)

• GMT of neutralizing antibody

  1 month after primary immunization

Study Arms (3)

Batch 1 of sIPV

EXPERIMENTAL

The first commercial batch of sIPV

Biological: sIPV batch 1

Batch 2 of sIPV

EXPERIMENTAL

The second commercial batch of sIPV

Biological: sIPV batch 2

Batch 3 of sIPV

EXPERIMENTAL

The third commercial batch of sIPV

Biological: sIPV batch 3

Interventions

sIPV batch 1 BIOLOGICAL

Type I 30 DU, Type II 32 DU, Type III 45 DU

Batch 1 of sIPV

sIPV batch 2 BIOLOGICAL

Type I 30 DU, Type II 32 DU, Type III 45 DU

Batch 2 of sIPV

sIPV batch 3 BIOLOGICAL

Type I 30 DU, Type II 32 DU, Type III 45 DU

Batch 3 of sIPV

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants of 2 months of age
• The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
• Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
• Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
• Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
• Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
• Axillary temperature ≤37℃

You may not qualify if:

• Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
• Patients with fever or acute disease.
• Have thrombocytopenia or hemorrhagic diseases
• Patients undergoing immunosuppressive therapy or immunodeficiency
• Have uncontrolled epilepsy or other progressive neurological disorders
• Other situations that the investigator consider as non-eligible

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Yunnan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Disease prevention and control center of Yunnan province

Kunming, Yunnan, 650022, China

Location

Related Publications (3)

• Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Quantitative Analysis of the Instant and Persistent Inhibition Effects of Maternal Poliovirus Antibodies on the Immune Response in a Phase IV Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine. Vaccines (Basel). 2024 Feb 19;12(2):217. doi: 10.3390/vaccines12020217.

  PMID: 38400200 DERIVED

• Yin Q, Zheng Y, Ying Z, Li J, Jiang Y, Bao W, Dou Y, Pu Y, Lei J, Yang H, Jiang R, Deng Y, Zhao Z, Pu J, Yang J, Li Y, Xu M, Cai W, Che Y, Shi L. Immunogenicity and lot-to-lot consistency of booster shot with Sabin inactivated poliomyelitis vaccine in Chinese children aged 18-24 Months: A phase Ⅳ clinical trial. Vaccine. 2024 Mar 19;42(8):1973-1979. doi: 10.1016/j.vaccine.2024.02.042. Epub 2024 Feb 21.

  PMID: 38388236 DERIVED

• Jiang R, Liu X, Sun X, Wang J, Huang Z, Li C, Li Z, Zhou J, Pu Y, Ying Z, Yin Q, Zhao Z, Zhang L, Lei J, Bao W, Jiang Y, Dou Y, Li J, Yang H, Cai W, Deng Y, Che Y, Shi L, Sun M. Immunogenicity and safety of the inactivated poliomyelitis vaccine made from Sabin strains in a phase IV clinical trial for the vaccination of a large population. Vaccine. 2021 Mar 1;39(9):1463-1471. doi: 10.1016/j.vaccine.2021.01.027. Epub 2021 Jan 22.

  PMID: 33487470 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Xiaoqiang Liu

  Disease prevention and control center of Yunnan province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: April 15, 2018
• Primary Completion: February 25, 2019
• Study Completion: October 12, 2019
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)