A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

NCT07019909 | Completed Phase 1

• 1 other identifier: B7471039
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

• Percentage of participants reporting prompted local reactions within 7 days following investigational product administration

  Prespecified local reactions (redness, swelling, and pain at the injection site)

  Within 7 days after vaccination

• Percentage of participants reporting prompted systemic events within 7 days following investigational product administration

  Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain)

  Within 7 days after vaccination

• Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration

  Adverse events occurring within 1 month after vaccination

  Within 1 month after vaccination

• Percentage of participants reporting serious adverse events (SAEs) throughout the study

  SAEs occurring within 6 months after vaccination

  Within 6 months after vaccination

• Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values

  Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values

  3 to 5 days after vaccination

Secondary Outcomes (2)

• Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)

  1 month after vaccination

• Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)

  Before vaccination to 1 month after vaccination

Study Arms (2)

20vPnC

EXPERIMENTAL

Single dose of 20-valent pneumococcal conjugate vaccine

Biological: 20vPnC

13vPnC

EXPERIMENTAL

Single dose of 13-valent pneumococcal conjugate vaccine

Biological: 13vPnC

Interventions

13vPnC BIOLOGICAL

13 valent pneumococcal conjugate vaccine

13vPnC

20vPnC BIOLOGICAL

20 valent pneumococcal conjugate vaccine

20vPnC

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.

You may not qualify if:

• History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
• Previous vaccination with any licensed or investigational pneumococcal vaccine or planned receipt through study participation.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Zhejiang provincial center for disease control and prevention

Hangzhou, Zhejiang, 310051, China

Location

Kaihua County Center For Disease Prevention and Control

Kaihua, Zhejiang, 324300, China

Location

Kaihua County Center For Disease Prevention and Control

Quzhou, Zhejiang, 324300, China

Location

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 6, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)