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Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Testing a new vaccine's safety for infants around 2 months old.

Recruiting
42-89 years
All
Phase 3

This study is testing a new vaccine called PCV21 for infants aged about 2 months. Pneumococcal conjugate vaccines protect against infections caused by the Streptococcus pneumoniae bacteria. The study compares PCV21 with an existing 20-valent vaccine, meaning the vaccine targets 20 types of bacteria. It is a Phase 3 trial, which means the vaccine has already been tested in earlier stages for safety.

Participants will be involved for about 19 months. The vaccine is given at 2, 4, 6, and 12-15 months. There will be a total of 6 study visits. Participation requires being healthy, born at full term or slightly early, and stable. Infants with certain medical conditions or past vaccinations may not be eligible.

  • Study lasts about 19 months with 6 visits.
  • Vaccine given at specific ages: 2, 4, 6, and 12-15 months.
  • Participants need to be healthy and born full-term or slightly early.

Always discuss with a healthcare provider to understand if joining a study is the right choice for your child.

Study details
    Pneumococcal Immunization

NCT06824194

Sanofi

30 August 2025

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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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