PCV21 Vaccine for Pneumonia

Recruiting at 168 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Seizure, Bleeding disorder, 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: 15 months

1630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new vaccine, PCV21, is safe and effective in helping infants' immune systems fight pneumonia. Researchers compare it to an existing vaccine, Prevnar 20, by administering both vaccines alongside regular shots. They seek healthy infants around two months old, born full-term or slightly early, who haven't received certain vaccines or experienced serious illnesses. Participants will attend six visits over 19 months to monitor progress. The study aims to ensure the new vaccine works well with regular vaccines to protect against pneumonia. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.

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 has shown that the PCV21 vaccine is generally well-tolerated. Safety data from earlier studies found the PCV21 vaccine to be as safe as the PCV13 vaccine, another pneumococcal vaccine. Most participants did not experience major side effects.

No serious reactions were linked to the vaccine, and no major health issues were reported. Most side effects, if they occurred, were mild, such as a sore arm at the injection site or a slight fever. This suggests that the PCV21 vaccine is safe, particularly when administered with routine vaccines for infants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the PCV21 vaccine because it aims to enhance protection against pneumonia with a broader range of coverage compared to existing vaccines. Unlike the standard 20-valent pneumococcal conjugate vaccine (20vPCV), PCV21 includes an additional serotype, potentially offering more comprehensive immunity against pneumococcal infections. This expanded coverage could be particularly beneficial in regions with diverse pneumococcal strains, making PCV21 a promising new option in the fight against pneumonia.

What evidence suggests that the PCV21 vaccine could be an effective treatment for pneumonia?

Research has shown that the PCV21 vaccine, which participants in this trial may receive, is promising in preventing diseases caused by certain bacteria not covered by other vaccines. In earlier studies, PCV21 significantly reduced cases of pneumococcal disease, such as pneumonia, in adults. The vaccine also reduced deaths related to these diseases compared to current vaccines. While most data comes from adult studies, these results suggest that PCV21 could offer strong protection against pneumococcal infections. Another group in this trial will receive the 20vPCV vaccine, serving as an active comparator. ^{6 7 8 9 10}

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.

I am considered healthy based on my recent medical exams.

I was born full-term or preterm but stable and met the weight criteria.

Exclusion Criteria

I have received immune globulins, blood, or blood products since birth.

I have a weak immune system or have been on long-term steroids or cancer treatment.

Any contraindication to the routine pediatric vaccines being administered in the study

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, co-administered with routine pediatric vaccines.

15 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the last vaccine dose, including assessment of antibody concentrations and adverse events.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PCV21 vaccine

Trial Overview The study tests if the PCV21 vaccine is safe and effective in producing antibodies compared to the Prevnar 20 vaccine when given alongside routine pediatric vaccines over a period of up to about 19 months with six scheduled visits.

How Is the Trial Designed?

Group I: Group 1: PCV21 Experimental Treatment 6 Interventions

Participants will be administered via intramuscular injection (IM) a 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax.

Group II: Group 2: 20vPCV Active Control 6 Interventions

Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax.

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

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]

The in-development 21-valent pneumococcal vaccine (PCV21) is projected to be more cost-effective and clinically beneficial than the currently recommended 15- or 20-valent vaccines for older adults, particularly for Black older adults who are at higher risk for pneumococcal disease.

In a Markov decision model analysis involving 65-year-old cohorts, PCV21 showed favorable cost-effectiveness ratios of $88,478 per quality-adjusted life-year (QALY) for Black individuals and $127,436/QALY for non-Black individuals, suggesting that PCV21 could justify a future recommendation for broader use in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of an in-development adult-formulated pneumococcal vaccine in older US adults. Wateska, AR., Nowalk, MP., Lin, CJ., et al.[2023]

The introduction of pneumococcal conjugate vaccines (PCV) in Ecuador led to a significant reduction in pneumonia hospitalizations among children under 5 years, with a 33% decrease observed in this age group.

PCV also contributed to a reduction in pneumonia mortality, with a 14% decrease in children under 1 year and a 22% decrease in adults aged 50-64 years, highlighting its potential impact on both pediatric and adult populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pneumococcal conjugate vaccine on pneumonia hospitalization and mortality in children and elderly in Ecuador: Time series analyses. Jimbo Sotomayor, R., Toscano, CM., Sánchez Choez, X., et al.[2021]

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]

The 13-valent pneumococcal conjugate vaccine (PCV13) was found to generate higher levels of anti-capsular immunoglobulin G (IgG) in the lungs compared to a control vaccine, indicating a strong local immune response for most serotypes.

However, PCV13 showed poor immunogenicity for serotype 3, suggesting that it may not provide adequate protection against this specific strain of pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirteen-Valent Pneumococcal Conjugate Vaccine-Induced Immunoglobulin G (IgG) Responses in Serum Associated With Serotype-Specific IgG in the Lung. Mitsi, E., McLenaghan, D., Wolf, AS., et al.[2023]

The 20-valent pneumococcal vaccine (PCV20) has been shown to elicit a strong immune response in older adults (65 years and older) one month after vaccination, based on two randomized controlled trials.

PCV20 is well-tolerated, with adverse events comparable to previous pneumococcal vaccines, suggesting it is a safe option for older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20-Valent Pneumococcal Conjugate Vaccine in Older People. Sewell, HE., Conway, S., Douglas, C.[2023]

In a study of 44 pediatric oncology patients, the heptavalent pneumococcal conjugate vaccine (PCV-7) resulted in protective antibody levels against all seven targeted serotypes, with increases in antibody concentrations ranging from 3.8-fold to 85.8-fold.

No cases of invasive pneumococcal disease were reported among the patients during the study, indicating that PCV-7 is effective in eliciting a strong immune response in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humoral response to conjugate pneumococcal vaccine in paediatric oncology patients. Cheng, FW., Ip, M., Chu, YY., et al.[2019]

In a study of 5,984 children aged 2 to 6 months, the heptavalent conjugated pneumococcal vaccine (PCV7) reduced respiratory tract infections by 10.5% and pneumonia by 6.3%, demonstrating its effectiveness in preventing these conditions.

PCV7 showed even greater effectiveness against pneumonia in children with medical risk factors, achieving a 38.4% reduction, and was found to be safe when given alongside other routine vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness against respiratory tract infections for pneumococcal conjugate vaccine co-administered with routine vaccine combinations. Adam, D., Fehnle, K.[2015]

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]

Citations

1. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7336a3.htm

Use of 21-Valent Pneumococcal Conjugate Vaccine .. ... Adding PCV21 as an option in the current PCV recommendation is expected to prevent additional disease caused by pneumococcal serotypes unique to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11582112/

Cost-Effectiveness Analysis of the Use of V116, a 21- ... The use of PCV21 by PCV-naïve adults aged ≥65 would markedly reduce the burden of adult pneumococcal disease, making substantial contributions ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25002828

Cost-effectiveness analysis of 21-valent pneumococcal ... The two-way sensitivity analysis revealed that the price per dose of PCV21 should be reduced by at least 7 % for the unhoused, 12 % for IC and ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00627-0/fulltext

What About Vaccine-Experienced Younger Adults? Cost ... Among 50-64 year-olds, compared with PPSV23, the ICER of PCV21 was $62,400/QALY in PCV13-experienced and $85,400 in PCV15-experienced. PCV21 was ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/13696998.2025.2496070

Economic evaluation of PCV21 in vaccine-naïve adults ... The findings revealed that the PCV21 strategy resulted in fewer cases of pneumococcal disease (PD) and related fatalities when compared to the recommended ...

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

Pneumococcal Vaccine Safety PCV21 helps protect against eight new types of pneumococcal bacteria that commonly cause severe illness in adults and are not included in other ...

7. vaccinesafety.edu vaccinesafety.edu/pneumococcal/

Pneumococcal The safety of PPSV23 vaccine in pregnancy has not been studied. However, no adverse outcomes have been reported among newborns whose mothers were inadvertently ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11392227/

Use of 21-Valent Pneumococcal Conjugate Vaccine Among ... PCV21 Safety​​ Safety data from four PCV21 phase III clinical trials (11,13–15) were pooled for the following participants: pneumococcal vaccine– ...

9. capvaxive.com capvaxive.com/

CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine ... CAPVAXIVE is a vaccine for individuals 18 years of age and older to help protect against invasive pneumococcal disease and pneumonia caused by certain types of ...

10. journals.lww.com journals.lww.com/pidj/fulltext/2025/10000/safety_and_immunogenicity_of_a_pneumococcal.19.aspx

Safety and Immunogenicity of a Pneumococcal Conjugate... Overall, the 3 PCV21 formulations were well tolerated and showed acceptable safety profiles, comparable to that of PCV13, in both cohorts (Table 1). No safety ...