Pneumococcal Vaccine for Pneumonia Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, PCV21, designed to prevent pneumonia in infants. The main goal is to assess the safety of this vaccine compared to an already-approved one. Healthy infants, born full-term or slightly premature but stable, and between 42 to 89 days old, may qualify for this study. Participants will receive four vaccine doses over approximately a year, alongside their regular vaccinations. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking vaccine for infants.
Will I have to stop taking my current medications?
The trial does not specify if participants must stop taking their current medications. However, if you are on immunosuppressive therapy, long-term systemic corticosteroids, or have received certain vaccines recently, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the PCV21 vaccine is generally well-tolerated. Studies indicate that its reactions resemble those of older vaccines like PCV13. Common side effects include pain and swelling at the injection site, occurring in more than 70% of cases. These effects are typical and usually mild.
The 20vPCV vaccine, used for comparison, has already received approval and has proven safe for infants. It often causes mild reactions like pain and swelling at the injection site.
In summary, both vaccines have safety records suggesting they are well-tolerated, with most side effects being mild and temporary.12345Why do researchers think this study treatment might be promising?
Researchers are excited about PCV21 because it offers a potentially broader coverage against pneumococcal strains compared to existing vaccines like PCV13 and 20vPCV. Unlike these standard options, PCV21 includes additional serotypes, which could enhance its ability to prevent pneumonia caused by a wider array of bacterial strains. This expanded protection is particularly promising in combating antibiotic-resistant strains, potentially reducing the incidence of pneumonia and its associated complications.
What evidence suggests that this trial's treatments could be effective for pneumonia prevention?
Research has shown that the PCV21 vaccine, which participants in this trial may receive, might protect against more types of bacteria causing pneumonia compared to older vaccines. This could result in fewer cases of pneumonia. Studies also suggest that PCV21 is a cost-effective method for preventing more instances of the disease. Overall, early evidence supports its potential to effectively protect against pneumonia. Another group in this trial will receive the 20vPCV vaccine, serving as an active comparator.16789
Are You a Good Fit for This Trial?
This trial is for healthy infants aged approximately 2 months (42 to 89 days) at the time of inclusion. They must be deemed healthy by a medical evaluation, which includes their medical history and physical examination.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 4-dose regimen of either PCV21 or 20vPCV vaccine at approximately 2, 4, 6, and 12 to 15 months of age
Follow-up
Participants are monitored for safety and effectiveness after the last vaccine injection
What Are the Treatments Tested in This Trial?
Interventions
- PCV21
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University