A Study to Evaluate 20vPnC in Healthy Chinese Infants

NCT07754539 | Recruiting Phase 3 DMC

• 1 other identifier: B7471022
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pneumococcal Diseases

Outcome Measures

Primary Outcomes (7)

• Percentage of participants reporting prespecified local reactions

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

• Percentage of participants reporting prespecified systemic events

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

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

  From the first study vaccination to 1 month after the third study vaccination

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

  From the fourth study vaccination to 1 month after the fourth study vaccination

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

  From the first study vaccination to 6 months after the last study vaccination

• 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

  At 1 month after Dose 3

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

  At 1 month after Dose 3

Secondary Outcomes (3)

• 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

  At 1 month after Dose 4

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

  At 1 month after Dose 4

• To further describe the immune response of 20vPnC

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

Study Arms (2)

13vPnC group

ACTIVE COMPARATOR

Participants receive 13vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)

Biological: 13vPnC

20vPnC group

EXPERIMENTAL

Participants receive 20vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)

Biological: 20vPnC

Interventions

13vPnC BIOLOGICAL

13vPnC vaccine

13vPnC group

20vPnC BIOLOGICAL

20vPnC vaccine

20vPnC group

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, 542800, China

RECRUITING

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530021, China

RECRUITING

Wuming District Center for Disease Control and Prevention

Nanning, Guangxi, 530199, China

RECRUITING

Zhongshan County Center for Disease Control and Prevention

Zhongshan Town, Guangxi, 542600, China

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 10, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): May 31, 2031
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)