NCT04481191

Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 48 Days – 63 Days
• Healthy volunteers: Accepted

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.

Conditions

• Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9

Interventions

Type	Name	Description
BIOLOGICAL	RotaTeq (V260)	Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
BIOLOGICAL	IPV	0.5 mL dose IPV (Sabin strain based), administered via IM injection

Timeline

• Start date: 2020-08-25
• Primary completion: 2021-05-08
• Completion: 2021-05-08
• First posted: 2020-07-22
• Last updated: 2024-07-26
• Results posted: 2023-02-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study