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NCT Number: NCT07573462

A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

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 infants 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. 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 infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are:

- infants who are about 2 months of age

About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.

Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Recruiting

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

42 day–98 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Milestone Research Inc., London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Infants who are about 2 months of age
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, 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.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

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 reporting local reactions within 7 days after each dose

    Time frame: Day 7

    Prompted local reactions after each dose

  2. Percentage of participants reporting systemic events within 7 days after each dose

    Time frame: Day 7

    Prompted systemic events after each dose

  3. Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3

    Time frame: Dose 1 to 1 month after Dose 3

    AEs occurring from Dose 1 to 1 month after Dose 3

  4. Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4

    Time frame: Dose 4 to 1 month after Dose 4

    AEs occurring from Dose 4 to 1 month after Dose 4

  5. Percentage of participants reporting serious adverse events (SAEs)

    Time frame: Dose 1 to 6 months after Dose 4

    SAEs occurring from Dose 1 to 6 months after Dose 4

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-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 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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