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Immunogenicity of a Booster Dose of Fractional Inactivated Poliovirus Vaccine (fIPV) Delivered Intradermally Concomitantly With Rotavirus Vaccines
This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.
Details
| Lead sponsor | Centers for Disease Control and Prevention |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 1144 |
| Start date | 2016-09 |
| Completion | 2017-05 |
Conditions
- Poliomyelitis
Interventions
- IPV at 14 and 22 weeks of age, Rotarix
- IPV at 14 and 22 weeks of age, RotaTeq
- IPV at 14 and fIPV at 22 weeks, Rotarix
- IPV at 14 and fIPV at 22 weeks, RotaTeq
- IPV at 6 and fIPV at 22 weeks, Rotarix
- IPV at 6 and fIPV at 22 weeks, RotaTeq
- fIPV at 6-14-22 weeks of age, Rotarix
- fIPV at 6-14-22 weeks of age, RotaTeq
Primary outcomes
- Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines. — Measured at 26 weeks of age.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (\<1:8 titers) who becomes seropositive (≥1:8) between designated time points. For selected objectives, baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days. - Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines (priming). — Measured at 23 weeks of age.
Priming is defined as the absence of type-specific immune response at 22 weeks with evidence of type-specific seroconversion at 23 weeks. That is, seronegative participants at 22 weeks (\<1:8 titers) who become seropositive at 23 weeks (≥1:8) or a four-fold rise in type-specific antibody titers at 23 weeks compared to 22 weeks. - Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines. — Measured at 22 weeks of age.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (\<1:8 titers) who becomes seropositive (≥1:8) between designated time points. Baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.
Countries
Bangladesh