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ACTIVE NOT RECRUITING
NCT06621654
PHASE1

Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Jiulongpo District Center for Disease Control and Prevention

Chongqing, China