Pneumococcal Vaccine for Pneumonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, PCV21, to determine if it can safely help infants build immunity against pneumonia compared to an already approved vaccine. The researchers will administer the vaccine alongside regular baby shots to assess its effectiveness in creating antibodies, the body's defense against germs. Full-term and preterm infants who are healthy and born at a medically stable weight may qualify for this trial. Participants will attend visits over approximately 20 months to receive the vaccine and monitor their health. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking vaccine for infants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term 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. Earlier studies found mostly mild and temporary side effects, such as soreness at the injection site and mild fever, with serious side effects being rare.
The PCV21 vaccine is being compared to the 15-valent pneumococcal vaccine (Vaxneuvance), which the FDA has approved for use in babies, indicating well-documented safety. Since PCV21 is in a Phase 3 trial, earlier studies have already tested its safety, revealing no major safety concerns so far.
Overall, the available data suggest that both vaccines are expected to be safe for use in babies.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the PCV21 vaccine because it targets a broader range of pneumococcal strains compared to existing pneumococcal vaccines like PCV13 and PPSV23. This means it has the potential to offer better protection against pneumonia caused by diverse strains of the bacteria. Additionally, PCV21 is administered alongside other vaccines such as Hexyon, MMRVaxPro, and Varivax, which could streamline the immunization process for infants. Most importantly, the PCV21 vaccine is designed to be effective even in preterm infants, offering a tailored dosing schedule to enhance protection in this vulnerable group.
What evidence suggests that this trial's vaccines could be effective for pneumonia?
Research has shown that the PCV21 vaccine, which participants in this trial may receive, can help prevent more diseases caused by certain types of pneumococcal bacteria not covered by other vaccines. Studies have found that PCV21 significantly reduces serious infections like pneumonia. This vaccine has successfully lowered the number of cases and deaths from these diseases, especially in adults. Although most research focuses on older people, the aim remains the same for infants: to strengthen their immune systems to better fight these infections by producing antibodies, which are proteins that combat germs. Therefore, PCV21 appears promising in boosting protection against pneumonia and related infections. Meanwhile, another group in this trial will receive the 15vPCV vaccine, which is also under study for its effectiveness in preventing pneumococcal diseases in infants.678910
Are You a Good Fit for This Trial?
This trial is for healthy infants aged approximately 2 months (42 to 112 days) at the time of inclusion. The study seeks participants who are in good health as confirmed 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 the study vaccines (PCV21 or 15vPCV) at approximately 2, 4, and 11 to 15 months of age, or at 2, 3, 4, and 11 to 15 months of age for preterm infants, co-administered with routine pediatric vaccines.
Follow-up
Participants are monitored for safety and effectiveness after the last vaccine injection, including monitoring for serious adverse events and antibody responses.
Long-term monitoring
Participants are monitored for adverse events of special interest and other safety outcomes throughout the study duration.
What Are the Treatments Tested in This Trial?
Interventions
- PCV21 vaccine
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