Who is sponsoring NCT04481191?

NCT04481191 is sponsored by Merck Sharp & Dohme LLC.

What condition does NCT04481191 study?

NCT04481191 studies Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9.

What drugs are being tested in NCT04481191?

Interventions: RotaTeq (V260), IPV.

What is the status of NCT04481191?

NCT04481191 is currently COMPLETED.

Last reviewed 2024-07-26 · How we verify

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

NCT04481191 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE3
Status	COMPLETED
Enrolment	400
Start date	Tue Aug 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat May 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

RotaTeq (V260)
IPV

Countries

China