One shot, two protections? study tests combined polio and rotavirus vaccines for infants
NCT ID NCT06331156
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether giving the polio vaccine (IPV) at the same time as a rotavirus vaccine (Rotarix PCV-free) is safe and works well in healthy Chinese infants aged 6-10 weeks. About 400 infants received the vaccines either together or a few weeks apart. The main goal was to see if the polio vaccine triggered a strong immune response when given with the rotavirus vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inactivated poliovirus vaccine (IPV) and live attenuated human rotavirus (HRV) vaccine
- What this could lead to
- If successful, this could support giving both vaccines at the same visit, simplifying infant immunization schedules.
- What could go wrong
- This is a completed phase 3 trial, but results are not yet published. The study only included healthy Chinese infants, so findings may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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400 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 10 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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). * History of poliomyelitis. * Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19). Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study interventions administration\*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations. \*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. * Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone \>=0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled, intra-articular and topical steroids are allowed. * Previous vaccination against RV. * Previous vaccination against poliomyelitis. Prior/Concurrent clinical study experience \- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention. Other exclusions \- Child in care.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GSK Investigational Site
Wenshan, 663300, China
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GSK Investigational Site
Yuechi-Guang'an, 638300, China
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GSK Investigational Site
Mianyang, 610041, China
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GSK Investigational Site
Neijiang, 641200, China
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GSK Investigational Site
Wenshan, 663100, China
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