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NCT Number: NCT07660198

Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

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 that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae

This study is seeking participants who:

* Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.

The study will be conducted in the United States, Puerto Rico, and other countries.

Participants will be assigned to 1 of 3 groups based on age:

Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)

Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).

At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

Recruiting

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Key information

Age range

15 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BRCR Global Puerto Rico, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.

Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.

Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.

Exclusion criteria

All Cohorts (Participants ≥15 Months to <18 Years of Age)

Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial

Treatment and study plan

PG4

Biological

Multivalent Pneumococcal Vaccine

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological

20-valent pneumococcal conjugate vaccine (20vPnC)

Other names: Prevnar 20

Primary outcomes

  1. Percentage of Participants With Local Reactions Within 7 Days After Vaccination

    Time frame: Within 7 days after Vaccination

  2. Percentage of Participants With Systemic Events Within 7 Days after Vaccination

    Time frame: Within 7 days after Vaccination

  3. Percentage of Participants With Adverse Events (AEs)

    Time frame: From Vaccination to 1 month after Vaccination

  4. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: From Vaccination to 6 months after Vaccination

  5. GMCs of serotype-specific IgG concentrations

    Time frame: 1 month after vaccination

  6. GMTs of serotype-specific OPA titers

    Time frame: 1 month after vaccination

Secondary outcomes

  1. Percentage of participants with predefined serotype-specific IgG concentrations

    Time frame: 1 month after vaccination

  2. IgG GMFRs

    Time frame: 1 month after vaccination

  3. Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers

    Time frame: before to 1 month after vaccination

  4. OPA GMFRs

    Time frame: before to 1 month after vaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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