Clinical trial NCT04224519: Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Official title: Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Lead sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Yunnan Center for Disease Control and Prevention
First posted: 2020-01-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.

A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.

Eligibility criteria: Inclusion Criteria:

* 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℃

Exclusion Criteria:

* 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

Primary outcomes:
measure: Seroconversion rate of neutralizing antibody
timeFrame: 1 month after primary immunization
measure: Local and systemic adverse reactions
timeFrame: Within 1 month after primary immunization
Secondary outcomes:
measure: GMT of neutralizing antibody
timeFrame: 1 month after primary immunization
Other outcomes:
Locations:
city: Kunming
country: China
facility: Disease prevention and control center of Yunnan province
state: Yunnan
Study officials:
affiliation: Disease prevention and control center of Yunnan province
name: Xiaoqiang Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.