Pneumococcal Vaccine for Children

Not currently recruiting at 51 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Severe allergic 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6-8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety, tolerability, and effectiveness of a pneumococcal vaccine in boosting immunity in toddlers. The study will compare different vaccination routines: one group will receive a single dose, while another will receive two doses. It is designed for toddlers aged 12 to 15 months who are generally healthy and have already received three doses of the 20-valent pneumococcal conjugate vaccine in infancy. Participants will visit the clinic several times over 6 to 8 months, provide blood samples, and report any side effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important vaccine development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study team or your doctor.

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

Research has shown that the 20-valent pneumococcal conjugate vaccine (20vPnC) is generally safe for young children. In earlier studies, this vaccine proved to be as safe as an older version, PCV13, which is already widely used. The new vaccine is well-tolerated, with no unusual or severe side effects reported. The most common reactions include mild soreness at the injection site or a slight fever, similar to reactions seen with many other vaccines. Overall, evidence suggests that the 20vPnC is safe for children and helps protect them against 20 types of bacteria that can cause serious infections. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the 20-valent pneumococcal conjugate vaccine (20vPnC) because it offers broader protection against pneumococcal disease compared to current vaccines. While existing vaccines like the 13-valent pneumococcal conjugate vaccine cover 13 strains, the 20vPnC targets 20 different strains, potentially reducing the risk of infection more effectively. This vaccine could lead to fewer cases of pneumonia, meningitis, and other serious infections caused by pneumococcal bacteria in children. The potential for a single-dose option, as investigated in one of the trial arms, could also simplify vaccination schedules and improve compliance.

What evidence suggests that this trial's treatments could be effective for pneumococcal vaccination in children?

Research shows that the 20-valent pneumococcal conjugate vaccine (20vPnC), which participants in this trial may receive, effectively increases protection against pneumococcal disease in children. Studies have found that this vaccine protects against more strains of the disease than older vaccines, such as the 13-valent version. In previous trials with infants and toddlers, the vaccine did not cause major side effects, indicating it was well-tolerated. Additionally, using the 20vPnC vaccine in children prevented more cases of pneumococcal disease and reduced deaths compared to older vaccines. This suggests strong potential for protecting children. ^{1 2 4 6 7}

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 toddlers who need to be healthy with no history of pneumococcal disease or prior vaccination against it. They should not have any known allergies to vaccine components and must be able to attend multiple clinic visits.

Inclusion Criteria

My toddler is healthy as per the doctor's assessment.

My child has received all 3 doses of the 20vPnC vaccine on schedule.

My child is between 12 and 15 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 either one or two doses of the Multivalent Pneumococcal Vaccine

6-8 months

2-3 clinic visits, 1 phone visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events and serious adverse events

6 months

What Are the Treatments Tested in This Trial?

Interventions

• 20-valent pneumococcal conjugate vaccine (20vPnC)

Trial Overview

The study is testing a new pneumococcal vaccine called PG4, also known as the 20-valent pneumococcal conjugate vaccine (20vPnC). It aims to understand its safety and how well it can stimulate an immune response in children.

How Is the Trial Designed?

Group I: PG4 2-Dose Group Experimental Treatment 1 Intervention

Participants to receive two injections of Multivalent Pneumococcal Vaccine

Group II: PG4 1-Dose Group Experimental Treatment 1 Intervention

Participants to receive a single injection of Multivalent Pneumococcal Vaccine

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

Participants to receive a single injection of 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

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]

In a study of 115 children aged 2-3 years who had not been previously vaccinated, the pneumococcal seven-valent conjugate vaccine (Prevenar) was found to be safe, with common local reactions like redness (40%) and tenderness (39.1%), and systemic reactions such as fever in only 7% of cases.

The vaccine demonstrated high immunogenicity, with over 98% of participants achieving sufficient antibody levels for all seven serotypes, indicating it effectively stimulates the immune response in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar) administered in previously unvaccinated Spanish children aged 24 to 36 months. de Arístegui Fernández, J., Cos Arregui, B., Zurimendi Carril, A., et al.[2022]

PCV13 (Prevnar 13®) is a pneumococcal vaccine that provides comprehensive coverage against over 85% of important pneumococcal serotypes, adding six new serotypes to the previously used PCV7 (Prevnar®).

The vaccine has demonstrated a satisfactory safety profile and effective immunologic responses comparable to PCV7, making it a promising option for preventing pneumococcal disease in children worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and clinical evaluation of Prevnar 13, a 13-valent pneumocococcal CRM197 conjugate vaccine. Gruber, WC., Scott, DA., Emini, EA.[2016]

The 13-valent pneumococcal conjugate vaccine (PCV13) was approved by the FDA on February 24, 2010, for preventing invasive pneumococcal disease and otitis media in children aged 6 weeks to 71 months, showing its efficacy against 13 specific serotypes.

The Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination with PCV13 for all children aged 2-59 months and for at-risk children aged 60-71 months, indicating its importance in public health for reducing pneumococcal disease burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010. [2022]

A large safety monitoring study involving 599,229 doses of the 13-valent pneumococcal vaccine (PCV13) found no increased risk of serious adverse events like febrile seizures or anaphylaxis in children aged 1 month to 2 years.

While no significant increased risk of adverse events was identified compared to the previous 7-valent vaccine (PCV7), a potential association with Kawasaki disease warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in children. Tseng, HF., Sy, LS., Liu, IL., et al.[2022]

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 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) 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]

The 20-valent pneumococcal conjugate vaccine (PCV20) showed consistent and robust immune responses across three different lots, indicating its effectiveness in generating immunity against all 20 serotypes tested.

The safety profile of PCV20 was comparable to that of the 13-valent vaccine (PCV13), with similar rates of mild to moderate local reactions and adverse events, suggesting it is a safe option for vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Klein, NP., Peyrani, P., Yacisin, K., et al.[2022]

The 13-valent pneumococcal conjugate vaccine (PCV13) is effective in preventing invasive pneumococcal disease in children and was approved for use in adults aged 50 and older to prevent pneumonia and related diseases.

Safety data and immunogenicity studies for PCV13 in adults were summarized to support recommendations for its use, highlighting its importance in protecting older populations from serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. [2012]

Citations

1.

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.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40459051/

Cost-effectiveness analysis of 20-valent pneumococcal ...

Objective: The aim of the present study was to evaluate the cost-effectiveness of 20-valent pneumococcal conjugate vaccine (PCV20) compared to 13-valent ...

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X24006169

Cost-effectiveness analysis of the 20-valent pneumococcal ...

In the pediatric population, vaccination with PCV20 prevented more cases of pneumococcal disease and death than PCV13, while lowering total ...

5.

prevnar20pediatric.pfizerpro.com

prevnar20pediatric.pfizerpro.com/

PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine ...

Prevnar 20 helps to strengthen babies' defense against invasive pneumococcal disease with the broadest serotype coverage available in a pediatric pneumococcal ...

6.

prevnar20.com

prevnar20.com/

PREVNAR 20® (Pneumococcal 20-Valent Conjugate Vaccine ...

IMPORTANT SAFETY INFORMATION​​ Prevnar 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria ...

7.

pubmed.ncbi.nlm.nih.gov

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

A Phase Three Study of the Safety and Immunogenicity ...

A 4-dose series of PVC20 was well tolerated and elicited robust serotype-specific immune responses expected to help protect infants and young children.