A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant

Phase 1

Recruiting

• Conditions: Pneumococcal Disease
• Interventions: Biological: 20vPnC

• Registration Number: NCT07023081
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC). This vaccine will be given as per the age-specific dosing schedules among healthy adults, children and infants in China.

This study is seeking healthy participants of 5 specific age groups:

* Group 1: Adults ≥18 to \<50 years of age

* Group 2: Children ≥2 to \<6 years of age

* Group 3: Children ≥12 months to \<2 years of age

* Group 4: Infants ≥7 to \<12 months of age

* Group 5: Infants ≥42 to ≤98 days of age

All participants in this study will receive 20vPnC as per the age-specific dosing schedules:

* Group 1: participants will receive 1 dose of 20vPnC.

* Group 2: participants will receive 1 dose of 20vPnC.

* Group 3: participants will receive 2 doses of 20vPnC. Dose 2 will be given 56 to 70 days after Dose 1.

* Group 4: participants will receive 3 doses of 20vPnC. Dose 2 will be given 28 to 56 days after Dose 1, and Dose 3 will be given at 365 to \<455 days of age and at least 56 days after Dose 2.

* Group 5: participants will receive 4 doses of 20vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to \<455 days of age.

The study will look at the experiences of people receiving the study vaccine. This will help decide if the study vaccine is safe.

The total duration of taking part in the study from each group is:

* Participants in Group 1 and Group 2 will take part for about 6 months, with 6 visits.

* Participants in Group 3 will take part for about 8 months, with 9 visits.

* Participants in Group 4 will take part for about 12 months, with 8 visits.

* Participants in Group 5 will take part for about 16 to 19 months, with 11 visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Study Start: 2025-06-15
• Study First Posted: 2025-06-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04
• Primary Completion: 2027-05-14
• Study Completion: 2027-05-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3	20vPnC	Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2).
Cohort 4	20vPnC	Participants will receive 3 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 28 to 56 days after Vaccination 1 (Vaccination 2), and at 365 to \<455 days of age and at least 56 days after Vaccination 2 (Vaccination 3).
Cohort 5	20vPnC	Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to \<455 days of age (Vaccination 4).
Cohort 1	20vPnC	Participants will receive 1 dose of 20vPnC Vaccine.
Cohort 2	20vPnC	Participants will receive 1 dose of 20vPnC Vaccine.

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting prespecified local reactions within 7 days following each study intervention	Within 7 days of each study intervention	Prespecified local reactions following each study intervention
Percentage of participants reporting prespecified systemic events within 7 days following each study intervention	Within 7 days of each study intervention	Prespecified systemic events following each study intervention
Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration	1 month after the last vaccination	AEs occurring through 1 month following the last study intervention administration for participants of adults ≥18 to \<50 years of age at the time of consent, and children and infants ≥7 months to \<6 years of age at the time of consent.
Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention.	From the first study intervention to 1 month after the third study intervention	AEs occurring from the first study intervention through 1 month following the third study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention.	From the fourth study intervention to 1 month after the fourth study intervention	AEs occurring from the fourth study intervention to 1 month following the fourth study intervention in infants ≥42 to ≤98 days of age at the time of consent.
Percentage of participants reporting serious adverse events (SAEs) throughout the study	From the first study intervention to 6 months after the last study intervention	SAEs through 6 months following last study intervention

Trial Locations

Locations (2)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention; 🇨🇳 Nanning, Guangxi, China

Wuming District Center for Disease Control and Prevention; 🇨🇳 Chengxiang, Nanning, China