Pneumococcal Vaccine for Infants

Not currently recruiting at 73 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Severe vaccine reaction, Congenital malformation, others

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

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

Compensation: Varies

Number of Visits: 6

Duration: 12-15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pneumococcal vaccine, PG4, to determine its safety and effectiveness for infants compared to existing vaccines. Pneumococcal disease, caused by the Streptococcus pneumoniae germ, can lead to serious infections, so this vaccine could offer protection. The trial also examines how the vaccine performs when mixed in different solutions. Healthy infants born at full term (after 36 weeks) and now 2 months old are suitable candidates. Participants will receive vaccine doses over approximately one and a half years, with blood samples taken to measure immune response. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to discuss this with the study doctor to understand any specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the PG4 pneumococcal vaccine is undergoing safety testing in babies. Previous studies have found that similar vaccines, like the 20-valent pneumococcal conjugate vaccine (20vPnC), are generally safe for infants. These vaccines typically cause mild reactions, such as a sore arm or slight fever, which are common with many vaccines.

The PG4 vaccine is currently in Phase 2 testing, where researchers closely monitor any side effects and how well babies tolerate the vaccine. Since similar vaccines have been approved for use, this suggests that PG4 might also be safe, but it remains under study.

In summary, while early research suggests PG4 may be safe, the ongoing trial is crucial to confirm its safety and effectiveness in babies. Researchers will closely monitor participants throughout the study to ensure their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the 20-valent pneumococcal conjugate vaccine (20vPnC) and the multivalent pneumococcal vaccine (PG4) because they offer broader protection against pneumococcal infections in infants. Unlike the standard 15-valent pneumococcal conjugate vaccines (PCV15), the 20vPnC includes additional strains of the pneumococcus bacterium, potentially guarding against more types of infections. This extended coverage means that these vaccines might significantly reduce the incidence of pneumococcal diseases, such as pneumonia and meningitis, in young children. The multivalent PG4 vaccine also aims to improve immunity by targeting multiple strains, making it a promising candidate in enhancing overall vaccine efficacy.

What evidence suggests that this trial's treatments could be effective against pneumococcal disease?

Studies have shown that pneumococcal vaccines effectively protect against infections caused by the Streptococcus pneumoniae germ. This trial tests the new PG4 vaccine in separate treatment arms to determine if it can generate a strong immune response in infants, similar to existing vaccines like the 20-valent pneumococcal conjugate vaccine (20vPnC), which is also part of this trial. Research indicates that these vaccines significantly protect against diseases like pneumonia. The PG4 vaccine aims to help the body produce antibodies, proteins that fight off germs, to protect against these infections. Although specific data on PG4 is limited, its method resembles well-studied vaccines, suggesting it could effectively prevent pneumococcal diseases in infants. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy male or female infants who are 2 months old, born at least 36 weeks into pregnancy. They must be considered healthy by the study doctor to participate.

Inclusion Criteria

Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study

My baby was born full-term and is now 2 months old.

Exclusion Criteria

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis)

Major known congenital malformation or serious chronic disorder

Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 doses of the study vaccine at 2, 4, 6, and 12 to 15 months of age

12-15 months

6 visits (in-person), 1-2 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 20-valent pneumococcal conjugate vaccine (20vPnC)
• PG4

Trial Overview The trial is testing a new pneumococcal vaccine called PG4 against an existing one, Prevnar 20 (20vPnC). Infants will receive four doses and have their immune response measured through blood samples to see how well the vaccine works.

How Is the Trial Designed?

Group I: Group 4 PG4 Experimental Treatment 1 Intervention

Multivalent Pneumococcal Vaccine

Group II: Group 3 PG4 Experimental Treatment 1 Intervention

Multivalent Pneumococcal Vaccine

Group III: Group 2 PG4 Experimental Treatment 1 Intervention

Multivalent Pneumococcal Vaccine

Group IV: Group 1 PG4 Experimental Treatment 1 Intervention

Multivalent Pneumococcal Vaccine

Group V: Group 4 15-valent pneumococcal conjugate vaccine (PCV15) Active Control 1 Intervention

15-valent pneumococcal conjugate vaccine (PCV15)

Group VI: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) Active Control 1 Intervention

20-valent pneumococcal conjugate vaccine (20vPnC)

Group VII: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) Active Control 1 Intervention

20-valent pneumococcal conjugate vaccine (20vPnC)

Group VIII: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) Active Control 1 Intervention

20-valent pneumococcal conjugate vaccine (20vPnC)

20-valent pneumococcal conjugate vaccine (20vPnC) is already approved in United States, European Union for the following indications:

Approved in United States as Prevnar 20 for:

• Invasive pneumococcal disease in infants and children

Approved in European Union as Prevnar 20 for:

• Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

The introduction of the Prevnar vaccine in the childhood immunization schedule in the USA led to a significant decrease in pneumococcal disease, demonstrating its efficacy in preventing both invasive and non-invasive infections.

Prevnar not only provides long-lasting immunity for infants and young children but also helps reduce antibiotic resistance by targeting several resistant serotypes, making it a crucial tool in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of pneumococcal disease in the United Kingdom--the start of a new era. Clarke, SC.[2020]

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 7-valent conjugate pneumococcal vaccine effectively prevents 75-90% of invasive pneumococcal disease cases in children, depending on the distribution of vaccine serotypes in different countries.

Recent studies in North America indicate that mass vaccination campaigns not only protect vaccinated children but also reduce the spread of antibiotic-resistant vaccine serotypes in the community, suggesting broader public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[7-valent conjugate Pneumococcal vaccine and nasopharyngeal cavity]. Piffer, S.[2015]

The 13-Valent pneumococcal conjugate vaccine (PCV13) is as effective as the 7-Valent vaccine (PCV7) in generating immune responses against the common serotypes of pneumococcal disease, while also providing additional protection against 6 extra serotypes.

Both vaccines have similar safety profiles, with PCV13 showing mild reactogenicity, indicating it is a safe option for infants receiving routine vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Yeh, SH., Gurtman, A., Hurley, DC., et al.[2015]

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 13-valent pneumococcal conjugate vaccine (13vPnC) was found to be immunogenic in healthy Japanese adults, showing adequate antibody responses for most serotypes, which supports its potential use in children and older adults.

While there was a trend towards more local reactions with the 13vPnC compared to the 23-valent polysaccharide vaccine (23vPn), these reactions were mostly mild or moderate, indicating that the vaccine is generally well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. Scott, D., Ruckle, J., Dar, M., et al.[2016]

In a study involving 694 children aged 12-15 months, the immune response to the MMR, Hib, and varicella vaccines was found to be equally effective whether given together with the fourth dose of the PCV7 vaccine or separately, with over 90% of subjects showing a strong immune response.

The results indicate that coadministering PCV7 with MMR, Hib, and varicella vaccines is safe and effective, supporting its inclusion in the routine immunization schedule for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of measles-mumps-rubella, varicella and Haemophilus influenzae type b vaccines administered concurrently with a fourth dose of heptavalent pneumococcal conjugate vaccine compared with the vaccines administered without heptavalent pneumococcal conjugate vaccine. Black, SB., Cimino, CO., Hansen, J., et al.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38191278/

Cost-effectiveness of 20-valent pneumococcal conjugate ... This study evaluated the health and economic impact of vaccinating US infants with a new expanded valency PCV20 formulation.

2. cdc.gov cdc.gov/acip/grade/PCV20-child.html

20-valent pneumococcal conjugate vaccine (PCV20) for ... A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV20 among pediatric age groups.

3. publications.aap.org publications.aap.org/pediatrics/article/154/5/e2023065218/199593/Safety-of-a-4-Dose-20-Valent-Pneumococcal

Safety of a 4-Dose 20-Valent Pneumococcal Conjugate ... PVC20 was well-tolerated in previous phase 3 trials in infants and toddlers and is expected to expand protection against pneumococcal disease.

4. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2025.2525619

Cost-effectiveness analyses of 20-valent pneumococcal ... Of the nine pediatric studies, eight concluded that the PCV20 strategy would cost less and gain more (i.e., would be cost-saving) compared with either PCV15 or ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25002282

A phase 3 study of 20-valent pneumococcal conjugate ... The data from this phase 3 study in Europe show that 1 or 2 toddler doses of PCV20 after 2 infant PCV13 doses elicited immune responses that are ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06524414

NCT06524414 | A Study to Learn About How a New ... To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also ...

7. pfizerclinicaltrials.com pfizerclinicaltrials.com/pneumococcal-vaccine-clinical-trials-children

Pneumococcal Vaccine Clinical Trials for Children This study is researching how well the study vaccine (called PG4) works in babies who have not started their routine pneumococcal vaccine series. All children ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38535409/

A Phase Three Study of the Safety and Immunogenicity ... Conclusion: A 4-dose series of PVC20 was well tolerated and elicited robust serotype-specific immune responses expected to help protect infants ...

9. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-how-a-new-pneumococcal-vaccine-works-in-infants

A Study to Learn About How a New Pneumococcal Vaccine ... The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in ...

10. studypages.com studypages.com/s/pfizer-pediatric-pneumococcal-conjugate-vaccine-study-749842/

Pfizer Pediatric Pneumococcal Conjugate Vaccine Study This study aims to check how safe and well-tolerated the PG4 vaccine is and how well it helps the immune system in healthy infants.