A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-adminis… (NCT06331156) | Clinical Trial Compass
CompletedPhase 3
A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants
China400 participantsStarted 2024-03-22
Plain-language summary
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.
Who can participate
Age range6 Weeks – 10 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
* Healthy participants as established by medical history and clinical examination before entering into the study.
* A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
* Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion Criteria:
Medical conditions
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Hypersensitivity to latex.
* History of severe combined immunodeficiency.
* History of seizures or progressive neurological disease.
* Family history of congenital or hereditary immunodeficiency.
* Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).
* History of IS.
* Major congenital defects, or serious chronic illness as assessed by the investigator.
* Any contraindications to IPV.
* Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
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What they're measuring
1
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Timeframe: At Month 3.5 (1 month post-Dose 3 of IPV)