drugset / Trial / NCT06621654

Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

NCT06621654

Phase 1 Active not recruiting 160 enrolled CanSino Biologics Inc.
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Haemophilus Influenzae Type b Conjugate Vaccine Vaccine 0.5 ml Intramuscular
Subject Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine Vaccine 0.5 ml Intramuscular