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

Institute of Medical Biology, Chinese Academy of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Poliomyelitis

Treatments: Biological: sIPV batch 1; Biological: sIPV batch 3; Biological: sIPV batch 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04224519

20171217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 patients

Sex: All

Ages: 2 to 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 3 patient groups

Batch 1 of sIPV

Experimental group

Description:

The first commercial batch of sIPV

Treatment:

Biological: sIPV batch 1

Batch 2 of sIPV

Experimental group

Description:

The second commercial batch of sIPV

Treatment:

Biological: sIPV batch 2

Batch 3 of sIPV

Experimental group

Description:

The third commercial batch of sIPV

Treatment:

Biological: sIPV batch 3