WithdrawnNot Applicable

Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

Stopped: As vaccine coverage rates have drastically improved in Venezuela, the study lost its objective to show positive impact of the vaccine to stimulate higher usage

0Started 2014-12

Plain-language summary

This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and \< 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.

Who can participate

Age range

12 Weeks – 5 Years

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: For SGE subjects: * A male or female child aged 12 weeks to \< 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday. * Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period. * Onset of SGE ≤ 14 days prior to admission/ ED stay. * Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject. For Cases: • Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation. For Controls: * Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period. * Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation. * Subjects born within ± 2 weeks from the date of birth of the case. Exclusion Criteria: For SGE subjects: * Child in care. * Hospitalisation is unrelated to GE. * Onset of SGE \> 48 hours after admission to (or ED stay at) the hospital. * Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities. * Subject with immunodeficiency. * Subjects who live out of the federative entity where hospital(s) are located. For Controls: • Subject has previously participated as case in this stu…

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

Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).

Timeframe: During hospitalisation and after discharge (approximately 12 months from study initiation).

Trial details

NCT IDNCT01978223

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Infections, Rotavirus trials