NCT07017777

A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)

A Phase III, Observer-blind, Randomized Controlled Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Weeks – 2 Months
• Healthy volunteers: Accepted

Summary

This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 months (at least 6 weeks) who will be randomly assigned in a 1:1 ratio to receive either the experimental or control vaccine, with 100 in each group (200 in total) randomized to subgroups and subject to additional immunogenicity assessments. All participants will be evaluated for solicited adverse events for 7 days and unsolicited adverse events for 30 days post each vaccination. Immunogenicity evaluation will be performed in all participants at baseline and post the booster dose, while the sub-cohort participants will be evaluated for post primary series immunogenicity additionally.

Conditions

• Pneumococcal Infections
• Streptococcal Infections
• Bacterial Infections

Interventions

Type	Name	Description
BIOLOGICAL	PCV13i	3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)
BIOLOGICAL	Prevnar 13	3 doses: 2 months (Dose 1) months (Dose 2), 12-15 months (Booster dose)

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-02-15
• Completion: 2028-05-15
• First posted: 2025-06-12
• Last updated: 2026-02-27

Locations

3 sites across 1 country: Thailand