Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine (NCT06621654) | Clinical Trial Compass
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 range2 Months – 59 Years
SexALL
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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…