Pneumococcal Vaccine for Pneumonia Prevention
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
Must not be taking: Immunosuppressants, Anticoagulants, Corticosteroids, others
Disqualifiers: Immunodeficiency, Seizures, Bleeding disorders, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).
The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits:
Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.
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.
What data supports the effectiveness of the treatment PCV21 for pneumonia prevention?
Research shows that similar pneumococcal vaccines, like PCV13, have been effective in preventing pneumonia in adults and reducing hospitalizations in children. This suggests that PCV21 might also be effective in preventing pneumonia.
12345Is the pneumococcal vaccine generally safe for humans?
Pneumococcal vaccines, including PCV7 and other variants, are generally safe for humans. They may cause mild reactions like local soreness or fever, but serious side effects are rare. Some studies noted a possible link to reactive airway disease, which needs more research.
678910How is the PCV21 treatment different from other pneumonia prevention treatments?
PCV21 is unique because it likely builds on the PCV20 vaccine, which covers 20 different strains of the bacteria that cause pneumonia, offering broader protection than previous vaccines like PCV13. This expanded coverage can help protect against more types of pneumococcal infections, potentially reducing the risk of pneumonia more effectively.
48111213Eligibility Criteria
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
I am between 42 and 89 days old today.
I am considered healthy based on my recent medical exams.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
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
13 months
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the last vaccine injection
6 months
Participant Groups
The study compares the safety of a new pneumococcal vaccine called PCV21 with an already licensed one, Prevnar 20. Infants will receive vaccines at around 2, 4, 6, and between 12 to15 months old alongside routine pediatric vaccines.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: PCV21Experimental Treatment9 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA
Group II: Group 2: 20vPCVActive Control9 Interventions
Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tribe Clinical Research at Parkside Pediatrics - Site Number : 8400069Simpsonville, SC
Pas Research - Pittsburgh- Site Number : 8400050Pittsburgh, PA
Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013Birmingham, AL
Lakeview Clinical Research, LLC- Site Number : 8400054Guntersville, AL
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
References
Effectiveness of the 13-valent pneumococcal conjugate vaccine against adult pneumonia in Italy: a case-control study in a 2-year prospective cohort. [2019]Current strategies to prevent adult pneumococcal disease have been recently reviewed in Italy. We did a postlicensure study to estimate the direct vaccine effectiveness (VE) of the 13-valent pneumococcal conjugate vaccine (PCV13) against adult pneumococcal community-acquired pneumonia (pCAP).
Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. [2013]The pneumococcal conjugate vaccine (PCV) might prevent hospitalizations in children because of the role of Streptococcus pneumoniae in the complications of influenza infection. We investigated the benefit of PCV vaccination in preventing influenza hospitalization in children
Effectiveness of pneumococcal conjugate vaccine against hospital admissions for pneumonia in Australian children: a retrospective, population-based, record-linked cohort study. [2021]Reductions in pneumonia hospitalisations following introduction of pneumococcal conjugate vaccines (PCVs) have been reported from high-incidence and low-incidence settings but long-term data comparing vaccinated with unvaccinated children are sparse.
Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. [2022]A new 20-valent pneumococcal conjugate vaccine (PCV20) provides protection against 20 pneumococcal serotypes. The vaccine has the potential to decrease the impact of pneumococcal diseases in society and to increase health among vulnerable persons.
Pneumococcal conjugated vaccines: impact of PCV-7 and new achievements in the postvaccine era. [2008]Pneumococcal disease is a major health problem worldwide. Large, rapid declines in overall invasive pneumococcal disease and mucosal disease in children, reductions in vaccine-type disease in unvaccinated children and adults (indirect effects) and significant drops in antibiotic-resistant infections were observed after the introduction of a safe, available and immunogenic seven-valent pneumococcal vaccine. The determination of vaccine efficacy is a complex process, which includes efficacy, immunogenicity, safety, cross-reactivity, indirect effects and substantial geographic variation in serotype coverage. In this report, we perform an overview of the literature on current, investigational and potential candidate pneumococcal conjugated vaccines (PCVs). Every country should have its own strong and sustained surveillance system implemented to monitor the effects of vaccination on the frequency of vaccine and nonvaccine serotypes for invasive or mucosal disease, nasopharyngeal carriage and the indirect effects before and after introduction of PCV. New PCVs (PHiD-CV and PCV-13) may provide even greater coverage worldwide, especially in developing countries. Vaccine experts' efforts are currently focused on developing alternative vaccine strategies against pneumococcal infections, especially the development of vaccines based on pneumococcal proteins.
Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006). [2022]In this paper we present an overview of the literature on efficacy and safety trials of the various pneumococcal conjugate vaccines on the market (PCV7) and in development (PCV9, PCV11 and allegedly PCV10 and PCV13), as well as of observations from post-licensure studies. Seven- (PCV7) and nine-valent PCV (PCV9) are reported to be sufficiently immunogenic after administration of a 3+1 schedule in infants in various RCTs. PncOMPC (PCV7 with a protein of N. meningitidis as a carrier) is less immunogenic, though this may have no repercussions for the protective efficacy against clinical disease. PCV7 is 82-97% efficacious against vaccine serotype (VT) IPD, 90% efficacious against (clinically diagnosed) pneumococcal pneumonia, and, like the 11-valent PCV, 57% efficacious against VT acute otitis media. Naturally, it would be of paramount public health interest if the same levels of efficacy and effectiveness could be achieved with fewer doses. Trials studying 2+1 vaccination schedules for PCV7 and PCV9 generally show that the percentage of infants achieving the protective cut-off set by the World Health Organization (WHO) 1 month after the last priming dose, is comparable to that found at the same time point in studies administering 3+1 schedules. PCVs are generally very well tolerated and safe, also when co-administered with other childhood vaccines. As more and more countries are using these vaccines routinely, post marketing surveillance studies will further establish the safety profile of PCVs.
Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years. [2022]Pneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated.
The safety of 7-valent pneumococcal conjugate vaccine. [2007]Streptococcus pneumoniae is one of the most important bacterial pathogens of young children. Currently, there are several conjugate vaccines against S. pneumoniae in various stages of laboratory development, clinical evaluation or currently licensed. Heptavalent pneumococcal conjugate vaccine (Wyeth Lederle; PCV-7) is the only currently approved pneumococcal conjugate vaccine indicated against invasive pneumococcal disease for children younger than two years of age. Safety studies have shown that the PCV-7 is acceptably safe when administered alone, simultaneously with other childhood vaccines or in combination with Haemophilus influenzae type b conjugate vaccines. In addition, PCV-7 vaccine was generally safe and immunogenic among infants infected with HIV and those with sickle cell disease. Surveillance studies to monitor the serotype distribution in invasive pneumococcal disease is important to determine that PCV-7 continues to be the optimal vaccination for prevention of pneumococcal invasive disease.
Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. [2021]A 7-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV7) was licensed in the United States of America in 2000, but no comprehensive postmarketing review of safety has been carried out. We conducted a systematic review of the safety of PCV7 and other pneumococcal conjugate vaccines. A total of 42 studies were included in the review. Reactogenicity data from some randomized trials suggest that PCV7 may result in more local reactions and fever than certain comparison vaccines. However, the reactions were mild and self-limited, and PCV7 did not carry an increased risk of severe injection-site reactions or high fever. Some, although not all, of the randomized trials in children found that mild local and systemic reactions associated with PCV7 may increase with the number of doses, at least over the three-dose primary series. In addition, PCV7 and other pneumococcal conjugate vaccines were found to have tolerable reactogenicity in Native American and African populations and in medically high-risk groups for which pneumococcal vaccination is recommended. Two of the largest studies of PCVs, one involving PCV7 and the other, PCV9, found a statistically significant increased risk of hospitalization for reactive airway disease, including asthma. Another large trial of PCV9, however, did not find an increased risk of asthma. In conclusion, this review of the evidence did not identify any major safety problems with PCV7 or any other pneumococcal conjugate vaccine, with the possible exception of reactive airway disease, which may bear further scrutiny as additional data become available.
Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. [2018]In clinical trials of Pneumococcal Conjugate Vaccines (PCV), some adverse events have been reported more frequently in the PCV vaccinated. Ten-valent PCV (PCV10) was introduced into the Finnish National Vaccination Programme (NVP) in September 2010.
The potential role for protein-conjugate pneumococcal vaccine in adults: what is the supporting evidence? [2022]Vaccination with protein-conjugate pneumococcal vaccine (PCV) provides children with extraordinary protection against pneumococcal disease, although the protective effect may be blunted by the emergence of replacement strains. Studies in adults have compared PCV with pneumococcal polysaccharide vaccine (PPV) using surrogate markers of protection, namely, serum anticapsular IgG antibody and opsonic activity. Results suggest that PCV is at least as effective as PPV for the strains covered, but a definitive and consistent advantage has not been demonstrated. Unfortunately, persons who are most in need of vaccine do not respond as well as otherwise healthy adults to either vaccine. Newer formulations of PCV will protect against the most prevalent of the current replacement strains, but replacement strains will create a moving target for PCVs. Unless an ongoing trial comparing 13-valent PCV with placebo (not to PPV) demonstrates a clearly better effect than that seen in the past with PPV, cost-effectiveness considerations are likely to prevent widespread use of PCV in adults.
A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults ≥65 years of age with different prior pneumococcal vaccination. [2022]A 20-valent pneumococcal conjugate vaccine, PCV20, was developed to expand protection against vaccine-preventable pneumococcal disease. PCV20 contains the components of the 13-valent pneumococcal conjugate vaccine, PCV13, and includes capsular polysaccharide conjugates for 7 additional serotypes. Thus, PCV20 may cover those additional serotypes in individuals previously vaccinated with PCV13 or provide benefits of immunization with a conjugate vaccine to individuals previously immunized with a pneumococcal polysaccharide vaccine. This study described the safety and immunogenicity of PCV20 in adults ≥65 years of age with prior pneumococcal vaccination.
20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. [2023]20‑valent pneumococcal conjugate vaccine (PCV20; Prevnar 20®; Apexxnar®) is a pneumococcal conjugate vaccine (PCV) developed by Pfizer for active immunization for the prevention of pneumococcal infections. PCV20 has a similar structure and formulation to Pfizer's 13-valent PCV (PCV13; Prevnar 13®; Prevenar 13®), with the addition of polysaccharides to target seven further Streptococcus pneumoniae serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F). PCV20 has been approved for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae in adults since June 2021 in the USA and since February 2022 in the EU. Following further evaluation of its safety, immunogenicity, and effectiveness in pediatric populations, in April 2023 PCV20 received its first pediatric approval, in the USA, for active immunization for the prevention of invasive pneumococcal disease (IPD) caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks to 17 years of age and for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks to 5 years of age. This article summarizes the milestones in the development of PCV20 leading to this first pediatric approval for active immunization for the prevention of IPD and otitis media caused by S. pneumoniae.