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. 2019 Mar 26;2019(3):CD008521. doi: 10.1002/14651858.CD008521.pub4
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