CompletedPhase 3

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

United States, Canada, Hong Kong1,351 participantsStarted 2019-07-19

Plain-language summary

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

Who can participate

Age range

6 Weeks – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: * Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure. * Healthy subjects as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. Exclusion Criteria: Medical conditions * Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS). * Very prematurely born infants (born ≤28 weeks of gestation). * History of IS. * Family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Hypersensitivity to latex. * Major congenital defects or serious chronic illness, as assessed by the investigator. * Previous confirmed occurrence of Rotavirus Gastroenteritis (RV GE). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * History of Severe combined immunodeficien…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination

Timeframe: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)

Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination

Timeframe: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)

Number of Subjects With Any Unsolicited AEs

Timeframe: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)

Number of Subjects With Any Serious Adverse Events (SAEs)

Timeframe: Throughout the study period (from Day 1 up to Month 7 or Month 8)

Trial details

NCT IDNCT03954743

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-30

Results submitted2021-05-24

View on ClinicalTrials.gov More Infections, Rotavirus trials