Strep Throat Clinical Trials

Find Strep Throat Clinical Trials Near You

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) IN HEALTHY CHINESE INFANTS

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate a study vaccine called 20-valent pneumococcal conjugate vaccine (20vPnC). The study will assess whether the study vaccine is safe to use in healthy infants. It will also evaluate if the study vaccine can help the body make antibodies (known as immune response). These antibodies help protect against 20 types of pneumococcal bacteria. The study will compare 20vPnC with 13vPnC (control vaccine), which is approved for use in infants. The study is seeking participants who: * Are healthy infants * Aged 42 to 98 days of age at the time of consent. Infants will receive either 20vPnC or 13vPnC. Doses will be given at approximately 2, 4, and 6 months of age (Doses 1 through 3). A fourth dose will be given at 12 to 15 months of age. Infants will receive the same vaccine (20vPnC or 13vPnC) for all 4 doses. The total time of the study will be about 16 to 19 months. A subset of infants will be asked to stay in the study for longer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3 months
Healthy Volunteers: t
View:

• \- Healthy male or female infants born at ≥37 weeks of gestation and who are approximately 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered Day 1 of life) will be enrolled.

Locations
Other Locations
China
Hezhou Center for Disease Control and Prevention
RECRUITING
Hezhou
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
RECRUITING
Nanning
Wuming District Center for Disease Control and Prevention
RECRUITING
Nanning
Zhongshan County Center for Disease Control and Prevention
RECRUITING
Zhongshan Town
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-07-25
Estimated Completion Date: 2031-05-31
Participants
Target number of participants: 1250
Treatments
Active_comparator: 13vPnC group
Participants receive 13vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)
Experimental: 20vPnC group
Participants receive 20vPnC at approximately 2, 4, and 6 months of age (Doses 1 through 3) and 12 through 15 months of age (Dose 4)
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov