NCT04224519

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	sIPV batch 1	Type I 30 DU, Type II 32 DU, Type III 45 DU
BIOLOGICAL	sIPV batch 2	Type I 30 DU, Type II 32 DU, Type III 45 DU
BIOLOGICAL	sIPV batch 3	Type I 30 DU, Type II 32 DU, Type III 45 DU

Timeline

• Start date: 2018-04-15
• Primary completion: 2019-02-25
• Completion: 2019-10-12
• First posted: 2020-01-13
• Last updated: 2023-10-11

Locations

1 site across 1 country: China