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Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Sponsor: CanSino Biologics Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Months - 59 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-11-15
Completion Date
2026-10
Last Updated
2025-07-29
Healthy Volunteers
Yes
Conditions
Interventions
Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
Haemophilus Influenzae Type b Conjugate Vaccine
1 dose (0.5ml) of vaccine on day 0, Intramuscular injection
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
Haemophilus Influenzae Type b Conjugate Vaccine
3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection
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
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
Locations (1)
Jiulongpo District Center for Disease Control and Prevention
Chongqing, China