The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
8,000
Subjects receive two doses of the vaccine on the day of randomisation (day 0) and day 30.
Subjects receive two doses of the placebo on the day of randomisation (day 0) and day 30.
Icddr,B
Dhaka, Bangladesh
The protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine
The efficacy will be assessed by comparing the incidence rate of laboratory-confirmed S. flexneri-associated or S. sonnei-associated diarrhea between the vaccinated group and the placebo group. Statistical Analysis: Protective efficacy(%)=(control group incidence (person-year incidence)- vaccine group incidence (person -year incidence))/control group incidence (person-year incidence)x100%
Time frame: From day 30 post full immunization to the subsequent 24-month period.
The protective efficacy against diarrhea cases with positive bacterial culture for Shigella species
Evaluation of the protective efficacy of the vaccine against diarrhea cases with positive bacterial culture for Shigella species.
Time frame: From he first dose of immunization to 24-month period post full immunization.
Positive PCR testing for Shigella species
Evaluation of diarrhea cases with positive PCR testing for Shigella species
Time frame: From day 30 post full immunization to the subsequent 24-month period.
IgG antibody seroconversion (fourfold increase) rate on day 30 post full immunization for subgroup 1.
Subjects in immunogenicity subgroup 1, vaccine serotype-specific Shigella flexneri and Shigella sonnei IgG antibody seroconversion (fourfold increase) rate on day 30 post full immunization.
Time frame: The 30th day after two doses of the vaccine.
IgG antibody concentration on day 30 post full immunization for subgroup 1.
For subjects in immunogenicity subgroup 1, vaccine serotype-specific Shigella flexneri and Shigella sonnei antibody concentration on day 30 post full immunization.
Time frame: The 30th day after two doses of the vaccine.
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IgG antibody seroconversion (fourfold increase) rate on day 30 post full immunization for subgroup 2.
For subjects in immunogenicity subgroup 2, vaccine serotype-specific Shigella flexneri and Shigella sonnei IgG antibody seroconversion (fourfold increase) rate on day 30 post the first dose, day 30 post full immunization, half a year after the first immunization, and one year after the first immunization.
Time frame: From 30 day to 1 year after the first immunization.
IgG antibody concentration on day 30 post full immunization for subgroup 2.
For subjects in immunogenicity subgroup 2, vaccine serotype-specific Shigella flexneri and Shigella sonnei antibody concentration on day 30 post the first dose, day 30 post full immunization, half a year after the first immunization, and one year after the first immunization.
Time frame: From 30 day to 1 year after the first immunization.
AEs within 0-30 minutes after vaccination
The occurrence of any adverse events within 30 minutes after each dose of vaccine (number of instances, number of cases, incidence rate, and the relationship to the vaccine administration)
Time frame: Within 30 minutes after each dose of vaccine
Solicited AEs within 0-7 days after vaccination
The occurrence of solicited adverse events from Day 0 to Day 7 after each vaccine dose (number of instances, number of cases, incidence rate, and the relationship to the vaccine administration)
Time frame: Within 0-7 days after each vaccine dose.
Unsolicited AEs within 0-30 days after vaccination
The occurrence of unsolicited adverse events from Day 0 to Day 30 after each vaccine dose (number of instances, number of cases, incidence rate, and the relationship to the vaccine administration).
Time frame: Within 0-30 days after each vaccination
SAE within 0-6 months after primary immunization
The occurrence of Serious Adverse Events (SAEs) from after the first dose to 6 months after complete immunization (number of instances, number of cases, incidence rate, and the relationship to the vaccine administration)
Time frame: Within 0-6 months after primary immunization.