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NCT Number: NCT07754539

A Study to Evaluate 20vPnC in Healthy Chinese Infants

The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants.

The study is seeking participants who:

* Are healthy infants * Aged 42 to 98 days of age at the time of consent.

Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses.

The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.

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Key information

Conditions

Pneumococcal Diseases 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

Hezhou Center for Disease Control and Prevention, Hezhou, Guangxi, China

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Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.

Key Exclusion Criteria:

  • history of a severe adverse reaction associated with a vaccine and/or severe allergic reactions to any component of the study intervention.
  • significant neurological disorder or history of seizure or significant stable or evolving disorders.
  • major known congenital malformation or serious chronic disorder.
  • history of microbiologically proven invasive disease caused by S. pneumoniae.
  • known or suspected immunodeficiency or other conditions associated with immunosuppression.
  • previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.

Treatment and study plan

20vPnC

Biological

20vPnC vaccine

13vPnC

Biological

13vPnC vaccine

Primary outcomes

  1. Percentage of participants reporting prespecified local reactions

    Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4

  2. Percentage of participants reporting prespecified systemic events

    Time frame: From Day 1 (the day of vaccination) through Day 7 following Vaccinations 1, 2, 3, and 4

  3. Percentage of participants reporting Adverse Events (AEs) from the first study vaccination through 1 month following the third study vaccination.

    Time frame: From the first study vaccination to 1 month after the third study vaccination

  4. Percentage of participants reporting AEs from the fourth study vaccination to 1 month following the fourth study vaccination.

    Time frame: From the fourth study vaccination to 1 month after the fourth study vaccination

  5. Percentage of participants reporting serious adverse events (SAEs) through 6 months post last vaccination

    Time frame: From the first study vaccination to 6 months after the last study vaccination

  6. The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 3

    Time frame: At 1 month after Dose 3

  7. The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 3

    Time frame: At 1 month after Dose 3

Secondary outcomes

  1. The percentages of participants with predefined serotype-specific immunoglobulin G (IgG) concentrations in 20vPnC group compared to 13vPnC group at 1 month after Dose 4

    Time frame: At 1 month after Dose 4

  2. The serotype-specific IgG geometric mean concentrations (GMCs) in 20vPnC group compared to 13vPnC group at 1 month after Dose 4

    Time frame: At 1 month after Dose 4

  3. To further describe the immune response of 20vPnC

    Time frame: At prior to Dose 1, 1 months after Dose 3, prior to Dose 4 and 1 month after Dose 4

    Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)

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 AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) IN HEALTHY CHINESE INFANTS

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Aug 10, 2026
Registry last updated
Aug 10, 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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