drugset / Trial / NCT06621654
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |