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The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

Testing the ROTAVAC 5D vaccine to protect Chilean infants from rotavirus.

Recruiting
6-8 years
All
Phase 3

This study is testing a new rotavirus vaccine, called ROTAVAC 5D. Rotavirus is a virus that can cause diarrhea, especially in babies. The study will involve 5,800 healthy babies in Chile, who are 6-8 weeks old. Half will receive the vaccine, and the other half will receive a placebo (a fake vaccine) to compare results. The study is "double-blind," meaning neither the doctors nor the parents will know who is getting the real vaccine.

Some babies will have blood samples taken to check if their bodies create antibodies (proteins that fight germs) after getting the vaccine. Stool (poop) samples will also be collected if the baby gets a tummy illness.

  • The study lasts for about a year, with several visits to check the baby's health.
  • There might be some risks, like reactions to the vaccine or blood sampling discomfort.
  • Parents must not plan to move away within the next year to stay in the study.

Parents need to give permission for their baby to join. Babies who have had certain illnesses or treatments can't join. This research helps find out if the vaccine is safe and works well.

Study details
    Rotavirus Infection of Children

NCT06200844

Bharat Biotech International Limited

24 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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