Trial name or title | "Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study (fIPV)" |
Methods | Open‐label phase IV, randomized controlled trial |
Participants |
Number: 1144 Description: Infants 6 weeks of age (range: 42 ‐ 48 days) |
Interventions | 1. RV1 at 6 and 10 weeks of age 1.1 RV1 + full dose of IPV at 14 and 22 weeks of age 1.2 RV1 + full dose of IPV at 14 weeks of age and a fractional dose IPV at 22 weeks of age 1.3 RV1 + full dose of IPV at 6 weeks of age and a fractional dose IPV at 22 weeks of age 1.4 RV1 + fractional doses of IPV at 6, 14, and 22 weeks of age 2. RV5 at 6, 10, and 14 weeks of age 2.1 RV5 + full dose of IPV at 14 and 22 weeks of age 2.2 RV5 + full dose of IPV at 14 weeks of age and a fractional dose IPV at 22 weeks of age 2.3 RV5 + full dose of IPV at 6 weeks of age and a fractional dose IPV at 22 weeks of age 2.4 RV5 + fractional doses of IPV at 6, 14, and 22 weeks of age |
Outcomes | 1. Seroconversion 4. Rotavirus IgA geometric mean titres 5. Rotavirus IgA seroconversion and geometric mean titres by secretor status, Lewis and salivary ABO blood group phenotype |
Starting date | September 2016 Completion: December 2017 |
Contact information | Centers for Disease Control and Prevention |
Notes |
Location: Bangladesh Registration number: NCT02847026 Source of funding: Centers for Disease Control and Prevention |