Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine

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 pregnancy plan within 6 months (only for 18~59 years old)
• Fever with axillary temperature > 37.0°C
• Known or suspected to be suffering from acute diseases or serious chronic diseases (including: serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, serious skin diseases, malignant tumors, tuberculosis, etc.); or in the acute exacerbation of chronic diseases
• Those who have hypertension that cannot be controlled by medication (at the time of on-site measurement: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg) (only applicable to 18~59 years old)
• Any of the routine blood biochemistry indexes during the screening period judged to be clinically significant by the investigator (only applicable to 2~5, 18~59 years old)
• Have no spleen or functional absence of spleen
• Suffering from thrombocytopenia, bleeding disorders, or other coagulation disorders (which may cause contraindication to intramuscular injection)
• Immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroids for acute uncomplicated dermatitis) within the past 6 months
• Received blood products within 3 months prior to receiving the experimental drug
• Participation in other studies involving interventional studies within 1 month prior to receiving the investigational drug and/or during the study participation period
• Having received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to vaccination
• In the judgment of the investigator, due to a variety of medical, psychological, social or other conditions that are contrary to the trial protocol or that affect the subject's ability to sign informed consent

Exclusion criteria

for subsequent doses

• A vaccine-related serious adverse event occurred after the previous dose of vaccination
• Who has experienced a Grade 3 or higher allergic reaction related to the vaccine after the previous dose of vaccination
• Any other factors that, in the judgment of the investigator, make the subject unsuitable for continued participation in the clinical trial