Clinical trial NCT07019909: A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
timeFrame: Within 7 days after vaccination
measure: Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
timeFrame: Within 7 days after vaccination
measure: Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
timeFrame: Within 1 month after vaccination
measure: Percentage of participants reporting serious adverse events (SAEs) throughout the study
timeFrame: Within 6 months after vaccination
measure: Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values
timeFrame: 3 to 5 days after vaccination
Secondary outcomes:
measure: Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT)
timeFrame: 1 month after vaccination
measure: Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR)
timeFrame: Before vaccination to 1 month after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: