Study to Evaluate the Safety of Rotarix™ in Chinese Children (NCT01086436) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety of Rotarix™ in Chinese Children
China50 participantsStarted 2010-03-13
Plain-language summary
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
Who can participate
Age range
2 Years – 6 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:
* Subjects who the investigator believes that their parents/guardians (Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female subject of Chinese origin, between, and including, 2 and 6 years of age at the time of vaccination.
* Written informed consent obtained from the parent or legally acceptable representative of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs six months prior to the vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days of the Human Rotavirus vaccine or placebo with the exception of the routine childhood vaccines. Routine childhood vaccines must not be administered on the same day as the Human Rotavirus vaccine or placebo.
* Administration of immunoglobulins and/or any blood products since birth within three months preceding the study vaccine or planned administration during the study period.
* Major congenital defects or serious chronic illness.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history a…
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
1
Occurrence of each solicited symptom
Timeframe: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.