A Phase 1, Single-Arm Study to Evaluate the Safety and Tolerability of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children, and Infants

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 49
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Wuming District Center for Disease Control and Prevention
RECRUITING
Chengxiang
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
RECRUITING
Nanning
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2027-05-14
Participants
Target number of participants: 100
Treatments
Experimental: Cohort 1
Participants will receive 1 dose of 20vPnC Vaccine.
Experimental: Cohort 2
Participants will receive 1 dose of 20vPnC Vaccine.
Experimental: Cohort 3
Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2).
Experimental: Cohort 4
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).
Experimental: Cohort 5
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).
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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