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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group 1A | Experimental | Subjects aged 18-59 years |
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| Experimental vaccine group 2A | Experimental | Subjects aged 1-5 years |
|
| Control vaccine group 2B | Active Comparator | Subjects aged 1-5 years |
|
| Experimental vaccine group 3A | Experimental | Subjects aged 6-11 months |
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| Control vaccine group 3B | Active Comparator | Subjects aged 6-11 months |
|
| Experimental vaccine group 4A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 1 dose (0.5ml) of vaccine on day 0, Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions in all subjects | Within 30 days of each dose of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions in all subjects | Within 30 minutes of each dose of vaccine | |
| Adverse events in all subjects | Within 30 days of each dose of vaccine | |
| Incidence of SAEs in all subjects |
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Inclusion Criteria:
Exclusion criteria for first dose:
Exclusion criteria for subsequent doses
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| Name | Affiliation | Role |
|---|---|---|
| Hongying Li | Chongqing Center for Disease Control and Prevention (Chongqing Academy of Preventive Medicine) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiulongpo District Center for Disease Control and Prevention | Chongqing | China |
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Subjects aged 2 months
|
| Control vaccine group 4B | Active Comparator | Subjects aged 2 months |
|
| Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 1 dose (0.5ml) of vaccine on day 0, Intramuscular injection |
|
| Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 1 dose (0.5ml) of vaccine on day 0, Intramuscular injection |
|
| Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection |
|
| Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 3 doses (0.5ml per dose) at day 0, 1 month, and 18 months of age, Intramuscular injection |
|
| Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age, Intramuscular injection |
|
| Haemophilus Influenzae Type b Conjugate Vaccine | Biological | 4 doses (0.5ml per dose) at day 0, 2, 4 month, and 18 months of age. Intramuscular injection |
|
| From the first dose to 6 months after full vaccination |
| Incidence of abnormal and clinically significant (CS) white blood cell counts, hemoglobin, platelet counts, Alanine aminoTransferase (ALT), Aspartate Transaminase (AST), and TBIL assays in subjects 18-59, 2-5 years of age | Day 8 post-immunization |
| Proportion of 2-month-old subjects with anti-Hib-PRP antibody concentrations ≥1.0 μg/ml | 30 days after basic immunization, before booster immunization, 30 days after booster immunization |
| Positive transfer rate of anti-Hib-PRP antibodies in 2-month-old subjects | 30 days after basic immunization, before booster immunization, 30 days after booster immunization |
| Positivity of anti-Hib-PRP antibodies in 2-month-old subjects | 30 days after basic immunization, before booster immunization, 30 days after booster immunization |
| Geometric Mean Concentration (GMC) of anti-Hib-PRP antibodies in 2-month-old subjects | 30 days after basic immunization, before booster immunization, 30 days after booster immunization |
| Geometric Mean Increase (GMI) of anti-Hib-PRP antibodies in 2-month-old subjects | 30 days after basic immunization, before booster immunization, 30 days after booster immunization |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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