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Completed

NCT Number: NCT07019909

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

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

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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

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang provincial center for disease control and prevention, Hangzhou, Zhejiang, China

Loading trial locations.

About this study

The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:

  • are 50 years of age and older
  • did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past.

The participants will be grouped by three age groups:

  • Adults between 50 to 59 years of age
  • Adults between 60 to 64 years of age
  • Adults who are 65 years of age or above

All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.

The total duration of taking part in the study will be around 6 months, with 6 visits.

Who can participate

Healthy volunteers accepted: Yes

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

Key inclusion criteria:

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

Key exclusion criteria:

  • 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.

Treatment and study plan

20vPnC

Biological

20 valent pneumococcal conjugate vaccine

13vPnC

Biological

13 valent pneumococcal conjugate vaccine

Primary outcomes

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

    Time frame: Within 7 days after vaccination

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

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

    Time frame: Within 7 days after vaccination

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

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

    Time frame: Within 1 month after vaccination

    Adverse events occurring within 1 month after vaccination

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

    Time frame: Within 6 months after vaccination

    SAEs occurring within 6 months after vaccination

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

    Time frame: 3 to 5 days after vaccination

    Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values

Secondary outcomes

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

    Time frame: 1 month after vaccination

    Pneumococcal serotype-specific OPA GMTs

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

    Time frame: Before vaccination to 1 month after vaccination

    Pneumococcal serotype-specific OPA GMFRs

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Third-Party-Unblinded Trial to Evaluate the Safety and Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) and 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Pneumococcal Vaccine-Naïve Adults 50 Years of Age and Older in China

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Feb 25, 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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