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

Testing the ROTAVAC 5D vaccine for infants in Chile.

Recruiting
6-8 years
All
Phase 3

This study tests a new **oral rotavirus vaccine** called ROTAVAC 5D in babies from Chile who are 6-8 weeks old. **Rotavirus** is a virus that causes severe diarrhea in children. The study is **double-blind**, meaning neither the doctors nor the families know if the baby gets the real vaccine or a **placebo** (a fake treatment). The study will have 5,800 babies, with half getting the vaccine and half getting the placebo. Some babies will have blood tests to see how well their body fights the virus.

  • The study lasts about 12 months, and regular check-ups are needed.
  • Participation is voluntary, and families must give consent.
  • Babies must not have had a rotavirus vaccine before.

It's important to know that babies with certain health issues, like known allergies to the vaccine, serious illnesses, or previous treatments with certain medicines, cannot join. If your baby has diarrhea on the day of enrollment, they might need to wait. The study checks for safety and how well the vaccine works. Participation helps doctors learn more about preventing rotavirus. 🦠💉

Study details
    Rotavirus Infection of Children

NCT06200844

Bharat Biotech International Limited

24 January 2024

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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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