NCT05759520

Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants

Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants Aged 2 Months (at Least 6 Weeks) and 3 Months

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Fosun Adgenvax Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 3 Months
• Healthy volunteers: Accepted

Summary

This study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.

Conditions

• Streptococcus Pneumoniae Infection

Interventions

Type	Name	Description
BIOLOGICAL	13-valent pneumococcal conjugate vaccine (multivalent conjugate)	the 2-month-old experimental group and the 3-month-old group received the experimental vaccine
BIOLOGICAL	Prevenar 13	the 2-month-old control group received the active control vaccine

Timeline

• Start date: 2022-11-04
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-03-08
• Last updated: 2024-10-01

Locations

5 sites across 1 country: China