NCT06621654

Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

A Randomized, Partially Blinded, Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine in a Population Aged 2 Months and Older

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 2 Months – 59 Years
• Healthy volunteers: Accepted

Summary

This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the enrollment will be done according to the progression of age groups, from the oldest to the youngest, and the initial safety assessment will be conducted on the 8th day after the first dose of vaccination for each age group, and the next group will be enrolled only after the safety is confirmed.

Conditions

• Haemophilus Influenzae Type B Infection

Interventions

Type	Name	Description
BIOLOGICAL	Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine	1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
BIOLOGICAL	Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine	1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
BIOLOGICAL	Haemophilus Influenzae Type b Conjugate Vaccine	1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
BIOLOGICAL	Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine	3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection
BIOLOGICAL	Haemophilus Influenzae Type b Conjugate Vaccine	3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection
BIOLOGICAL	Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine	4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age, Intramuscular injection
BIOLOGICAL	Haemophilus Influenzae Type b Conjugate Vaccine	4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age. Intramuscular injection

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-10-01
• Last updated: 2025-07-29

Locations

1 site across 1 country: China