NCT06331156
Completed
Phase 3
A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants
ConditionsGastroenteritis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Gastroenteritis
- Sponsor
- GlaxoSmithKline
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Time Frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.
Secondary Outcomes
- Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab(At Month 3.5 (1 month post-Dose 3 of IPV))
- Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64(At Month 3.5 (1 month post-Dose 3 of IPV))
- Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Number of Participants Reporting Any Solicited Systemic Events(Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group))
- Number of Participants Reporting Any Unsolicited Adverse Events (AEs)(Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group))
- Number of Participants Reporting Any Serious Adverse Events (SAEs)(From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5))
Study Sites (1)
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