At a glance
ClinicalIndex Comparison Record- ✓Healthy Chinese infant aged 48 to 63 days at enrollment
- ✓Written informed consent from legally acceptable representative
- ✕History of rotavirus disease, congenital GI disorders, chronic diarrhea, failure to thrive, or abdominal surgery
- ✕History of intussusception
- ✕History of poliomyelitis
- ✕Clinical evidence of active gastrointestinal illness (except well-controlled GERD)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants
In Brief
A Phase 3 clinical trial evaluating RotaTeq (V260) and IPV for Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9. Completed, enrolled 400 participants across 1 site.
Detailed Summary
This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.
Study Details
Timeline
Interventions
Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
0.5 mL dose IPV (Sabin strain based), administered via IM injection