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

NCT07023081 | Active Not Recruiting Phase 1

• 1 other identifier: B7471021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. 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 6 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
• Group 6: Infants ≥42 to ≤98 days of age All participants in Group 1 to 5, 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. Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC: \- Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. 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. The study will also look at the immune response of some 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 and 6 will take part for about 16 to 19 months, with 11 visits.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (6)

• Percentage of participants reporting prespecified local reactions within 7 days following each study intervention

  Prespecified local reactions following each study intervention

  Within 7 days of each study intervention

• Percentage of participants reporting prespecified systemic events within 7 days following each study intervention

  Prespecified systemic events following each study intervention

  Within 7 days of each study intervention

• Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration

  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.

  1 month after the last vaccination

• Percentage of participants reporting AEs from the first study intervention through 1 month following 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.

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

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

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

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

  SAEs through 6 months following last study intervention

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

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participants will receive 1 dose of 20vPnC Vaccine.

Biological: 20vPnC

Cohort 2

EXPERIMENTAL

Participants will receive 1 dose of 20vPnC Vaccine.

Biological: 20vPnC

Cohort 3

EXPERIMENTAL

Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2).

Biological: 20vPnC

Cohort 4

EXPERIMENTAL

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).

Biological: 20vPnC

Cohort 5

EXPERIMENTAL

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).

Biological: 20vPnC

Cohort 6 (20vPnC)

EXPERIMENTAL

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).

Biological: 20vPnC

Cohort 6 (13vPnC)

ACTIVE COMPARATOR

Participants will receive 4 doses of 13vPnC 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).

Biological: 13vPnC

Interventions

20vPnC BIOLOGICAL

20vPnC vaccine

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6 (20vPnC)

13vPnC BIOLOGICAL

13vPnC vaccine

Cohort 6 (13vPnC)

Eligibility Criteria

• Age: 42 Days - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female participants:
• Adults ≥18 to \<50 years of age
• Children ≥2 to \<6 years of age
• Children ≥12 months to \<2 years of age
• Infants ≥7 to \<12 months of age
• Infants ≥42 to ≤98 days of age
• Healthy participants determined by clinical assessment and clinical judgment, to be eligible for the study.

You may not qualify if:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention, or any diphtheria toxoid-containing vaccine.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• Congenital, functional, or surgical asplenia.
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
• Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s).
• Please refer to the study contact for further eligibility details.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530021, China

Location

Wuming District Center for Disease Control and Prevention

Chengxiang, Nanning, 530199, 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: NONE
• Masking Details: This is an open label study. Participant, investigators, and sponsor will be unblinded to the participant's assigned study intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)