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Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

NCT06621654 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Hongying Li · Chongqing Center for Disease Control and Prevention (Chongqing Academy of Preventive Medicine)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06621654 on ClinicalTrials.gov