Active — Not RecruitingPhase 1

Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

China160 participantsStarted 2024-11-15

Plain-language 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.

Who can participate

Age range

2 Months – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects aged 2 months, 6-11 months, 1-5 years, and 18-59 years at the time of screening * Informed consent is obtained from the subject and the subject and/or guardian (attorney-in-fact) is able to sign the informed consent form * Subjects are able and willing to comply with the requirements of the clinical trial protocol and are able to complete the full study follow up Exclusion criteria for first dose: * 2 months old, 6 months old \~ 5 years old people have been vaccinated with Hib-containing vaccines * 2-month-old, 6\~11-month-old infants who were born prematurely (delivered before the 37th week of gestation), low birth weight (birth weight \<2500g) * 2-month-old, 6\~11-month-old infants with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage * Those with history of Haemophilus influenzae type b infection * Those with history of epilepsy, convulsions, convulsions, cerebral palsy, or history of psychiatric illness or family history or other progressive neurological diseases * Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases * History of allergy to vaccines or vaccine components, severe side effects to vaccines such as urticaria, dyspnea, angioneurotic edema * Female with positive urine pregnancy test or breastfeeding subjects, subjects or their partners with p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse reactions in all subjects

Timeframe: Within 30 days of each dose of vaccine

Trial details

NCT IDNCT06621654

SponsorCanSino Biologics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Haemophilus Influenzae Type B Infection trials