Pneumococcal Vaccine for Pneumonia Prevention

Recruiting at 133 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Immunosuppressants, Anticoagulants, Corticosteroids, others

Disqualifiers: Immunodeficiency, Seizures, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 13 months

2320 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

I am between 42 and 89 days old today.

I am considered healthy based on my recent medical exams.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PCV21

Trial Overview

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.

How Is the Trial Designed?

Group I: Group 1: PCV21 Experimental Treatment 9 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: 20vPCV Active Control 9 Interventions

Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Published Research Related to This Trial

The Heptavalent pneumococcal conjugate vaccine (PCV-7) is currently the only approved vaccine for preventing invasive pneumococcal disease in children under two years old, demonstrating good safety when given alone or with other vaccines.

PCV-7 has been shown to be safe and effective in infants with HIV and those with sickle cell disease, highlighting its broad applicability in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of 7-valent pneumococcal conjugate vaccine. Ghaffar, F.[2007]

The 13-valent pneumococcal conjugate vaccine (PCV13) showed an overall vaccine effectiveness (VE) of 33.2% against pneumococcal community-acquired pneumonia (pCAP) in adults aged 65 and older, indicating some level of protection despite modest vaccine uptake.

In a subgroup of patients managed in the community, the VE was significantly higher at 88.1% against any pneumococcal strain, suggesting that PCV13 could be particularly effective in community settings, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the 13-valent pneumococcal conjugate vaccine against adult pneumonia in Italy: a case-control study in a 2-year prospective cohort. Prato, R., Fortunato, F., Cappelli, MG., et al.[2019]

In a study involving 194 hospitalized children with influenza and 342 matched controls, the pneumococcal conjugate vaccine (PCV) significantly reduced hospitalizations by 48% during the 2009-2010 pandemic wave for fully vaccinated children under 5 years old.

However, during the 2010-2011 influenza season, the study found no significant benefit of PCV vaccination in preventing hospitalizations, indicating that the effectiveness of the vaccine may vary by season.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of conjugate pneumococcal vaccination in preventing influenza hospitalization in children: a case-control study. Domínguez, A., Castilla, J., Godoy, P., et al.[2013]

A systematic review of 42 studies found that the 7-valent pneumococcal conjugate vaccine (PCV7) is generally safe, with mild and self-limited local reactions and fever, but no increased risk of severe side effects.

While some studies indicated a potential link between pneumococcal vaccines and an increased risk of hospitalization for reactive airway disease, the overall safety profile of PCV7 remains favorable, warranting further investigation into this specific concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of pneumococcal conjugate vaccines: systematic review of pre- and post-licensure data. Destefano, F., Pfeifer, D., Nohynek, H.[2021]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well tolerated, with no significant safety concerns reported in a phase 3 study involving adults across three age groups (18-49, 50-59, and ≥60 years).

PCV20 demonstrated comparable immunogenicity to the 13-valent PCV (PCV13) and the 23-valent polysaccharide vaccine (PPSV23), effectively inducing immune responses to all 20 vaccine serotypes, which suggests it could provide broader protection against pneumococcal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years. Essink, B., Sabharwal, C., Cannon, K., et al.[2022]

A study analyzing data from Finnish population registers found no significant increase in adverse events after the introduction of the ten-valent Pneumococcal Conjugate Vaccine (PCV10) in children, except for a higher incidence of urticarial rash, which was attributed to changes in healthcare coding rather than the vaccine itself.

The findings suggest that public health concerns regarding adverse events linked to PCV10 are unfounded, highlighting the effectiveness of using real-world data for validating safety signals in vaccination programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. Artama, M., Rinta-Kokko, H., Nohynek, H., et al.[2018]

The protein-conjugate pneumococcal vaccine (PCV) offers strong protection against pneumococcal disease in children, but its effectiveness may be reduced by the emergence of new replacement strains.

Current evidence suggests that PCV is at least as effective as the pneumococcal polysaccharide vaccine (PPV) in adults, but those most in need of vaccination often have a weaker response, raising concerns about the cost-effectiveness of widespread PCV use in adult populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role for protein-conjugate pneumococcal vaccine in adults: what is the supporting evidence? Musher, DM., Sampath, R., Rodriguez-Barradas, MC.[2022]

A study of 1,365,893 children in Australia found that pneumococcal conjugate vaccines (PCVs) significantly reduced hospital admissions for pneumonia, particularly among Aboriginal children, who experienced a 49% reduction in admissions after full vaccination.

While both vaccinated and unvaccinated non-Aboriginal children showed decreased pneumonia admissions, the most substantial benefits of PCV were observed in Aboriginal children, highlighting the importance of vaccination in high-incidence populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pneumococcal conjugate vaccine against hospital admissions for pneumonia in Australian children: a retrospective, population-based, record-linked cohort study. Fathima, P., Gidding, HF., McIntyre, PB., et al.[2021]

The 20-valent pneumococcal conjugate vaccine (PCV20) has been approved for use in adults since June 2021 and in pediatric populations since April 2023, targeting a broader range of Streptococcus pneumoniae serotypes compared to the previous 13-valent vaccine.

PCV20 is effective in preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 17 years, demonstrating its safety and immunogenicity in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval. Shirley, M.[2023]

The 20-valent pneumococcal conjugate vaccine (PCV20) was found to be safe and well-tolerated in adults aged 65 and older, with similar rates of local reactions and adverse events compared to the control groups (PCV13 and PPSV23).

PCV20 elicited strong immune responses against all 20 serotypes included in the vaccine, demonstrating its effectiveness in boosting immunity regardless of prior pneumococcal vaccination history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Cannon, K., Elder, C., Young, M., et al.[2022]

Pneumococcal conjugate vaccines (PCV7 and PCV9) are highly immunogenic and effective, with PCV7 showing 82-97% efficacy against invasive pneumococcal disease and 90% against pneumococcal pneumonia, based on various randomized controlled trials.

PCVs are generally safe and well-tolerated, even when given alongside other childhood vaccines, and studies suggest that fewer doses (2+1 schedule) can achieve similar protective immunity as the standard 3+1 schedule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006). Oosterhuis-Kafeja, F., Beutels, P., Van Damme, P.[2022]

The 20-valent pneumococcal conjugate vaccine (PCV20) significantly reduces the incidence and mortality of pneumococcal diseases in Danish adults compared to the 23-valent pneumococcal polysaccharide vaccine (PPV23), leading to substantial health benefits.

Vaccination with PCV20 is a cost-effective strategy, potentially saving up to 396 million EUR while gaining thousands of quality-adjusted life years (QALYs), making it a dominant choice for adults at moderate or high risk and those aged 65 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in Denmark compared with PPV23. Olsen, J., Schnack, H., Skovdal, M., et al.[2022]

The introduction of the seven-valent pneumococcal vaccine has led to significant declines in invasive pneumococcal disease and antibiotic-resistant infections in children, demonstrating its efficacy and safety.

Newer pneumococcal conjugate vaccines (PHiD-CV and PCV-13) are being developed to provide broader coverage, particularly in developing countries, while ongoing research is exploring alternative vaccine strategies based on pneumococcal proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumococcal conjugated vaccines: impact of PCV-7 and new achievements in the postvaccine era. Dinleyici, EC., Yargic, ZA.[2008]

Citations

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Adding PCV21 as an option in the current PCV recommendation is expected to prevent additional disease caused by pneumococcal serotypes unique to ...

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Cost-Effectiveness Analysis of the Use of V116, a 21- ...

Based on the inputs and assumptions used, the results indicated that the V116 strategy prevented 27,766 and 32,387 disease cases/deaths and ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X25002828

Cost-effectiveness analysis of 21-valent pneumococcal ...

When indirect effects from PCV15 and serotype replacement were included, PCV21 was cost-effective for IC and unhoused populations, while PCV20 ...

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merck.com/news/systematic-review-of-15-studies-focused-on-epidemiology-and-antimicrobial-resistance-of-pneumococcal-serotypes-covered-by-capvaxive-pneumococcal-21-valent-conjugate-vaccine-in-u-s-adults/

Systematic Review of 15 Studies Focused on ...

CAPVAXIVE is Merck's 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and ...

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On June 27, 2024, ACIP recommended the use of PCV21 as an option for adults aged ≥19 years who currently have a recommendation to receive a dose of PCV.

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pmc.ncbi.nlm.nih.gov

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Use of 21-Valent Pneumococcal Conjugate Vaccine Among ...

* PCV21 is approved for the prevention of invasive pneumococcal ... Safety data from four PCV21 phase III clinical trials (11,13–15) ...

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cdc.gov/vaccine-safety/vaccines/pneumococcal.html

Pneumococcal Vaccine Safety

PCV21 helps protect against eight new types of pneumococcal ... A closer look at the safety data. A 2004 study of VAERS data found ...

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Pneumococcal

Reactions among adults to PCV15, PCV20 and PCV21 are similar to PCV13. Common reactions to PCV15 include injection site pain (>70%), injection site swelling (> ...

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secure.medicalletter.org/TML-article-1713a

Capvaxive – A 21-Valent Pneumococcal Conjugate Vaccine

4 No adequate data are available on the use of PCV21 in pregnant women. No adverse developmental outcomes were observed in animal studies. ACIP ...