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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,200
Type I 30 DU, Type II 32 DU, Type III 45 DU
Type I 30 DU, Type II 32 DU, Type III 45 DU
Type I 30 DU, Type II 32 DU, Type III 45 DU
Disease prevention and control center of Yunnan province
Kunming, Yunnan, China
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.
Time frame: 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.
Time frame: Within 1 month after primary immunization
GMT of neutralizing antibody
Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody. Intergroup differences analysis of antibody level was conducted.
Time frame: 1 month after primary immunization
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