The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants (NCT06200844) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Chile5,800 participantsStarted 2023-07-07
Plain-language summary
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
Who can participate
Age range
6 Weeks – 8 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
. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
. Subjects aged 6 to 8 weeks at recruitment
. No plans to move in the next 12 months
Exclusion criteria
. Administration of rotavirus vaccine in the past
. Presence of any illness requiring hospital referral (temporary exclusion)
. Known case of immunodeficiency disease, known HIV positive
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
To evaluate the efficacy of ROTAVAC5D
Timeframe: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
. Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease
. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
. Diarrhea on the day of enrollment (temporary exclusion)
. A known sensitivity or allergy to any components of the study vaccines.