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| Name | Class |
|---|---|
| Royal (Wuxi) Biological Co., LTD | OTHER |
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Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.
Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.
According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.
After the phase I study which was conducted in August, 2011, the safety profile of this vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children group A | Experimental | 600 children aged 2-5 years old, will be vaccinated on day0 |
|
| infants group A | Experimental | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
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| children group B | Active Comparator | 600 children aged 2-5 years old, will be vaccinated on day0 |
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| infants group B | Active Comparator | 600 infants aged 6-23 months old, will be vaccinated on day0, 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A+C+hib Conjugate Vaccine | Biological | The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered intramuscularly on one arm, per 0.5ml dose |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of antibody against group A, C polysaccharide meningitis in children after vaccination | to evaluate the seroconversion rate of antibody against group A, C polysaccharide meningitis in children when measured 4 weeks (28±3 days) after the vaccination | 4 weeks (28±3 days) after the vaccination |
| The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants after infant series | to evaluate the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants when measured 4 weeks (28±3 days) after the infant series (two times, 28 day apart). | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) |
| The seroconversion rate of antibody against type b haemophilus influenza in children after the vaccination | to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in children when measured 4 weeks (28±3 days) after the vaccination | 4 weeks (28±3 days) after the vaccination |
| The seroconversion rate of antibody against type b haemophilus influenza in infants after infant series | to evaluate the seroconversion rate of antibody against type b haemophilus Influenza in infants when measured 4 weeks (28±3 days) after the infant series (two times, 28 day apart) | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) |
| Measure | Description | Time Frame |
|---|---|---|
| Injection-site reactions and systemic events after the vaccination in children | to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy children for 7 days after the vaccination | 7 days after the vaccination |
| Injection-site reactions and systemic events after the first vaccination in infants |
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For the children (aged from 2 to 5 years old)
Inclusion Criteria:
Exclusion Criteria:
For the infants (aged from 6 to 23 months old)
Inclusion Criteria:
Exclusion Criteria for the first vaccination:
Exclusion Criteria for the second vaccination:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Funing county Center for Disease Control and Prevention | Funing County | Jiangsu | 224400 | China |
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| Placebo | Biological | Placebo will be administered intramuscularly on the other arm, per 0.5ml dose |
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| A+C Vaccine | Biological | The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose |
|
| Hib vaccine | Biological | The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose |
|
to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the first vaccination |
| 7 days after the first vaccination |
| Injection-site reactions and systemic events after the second vaccination in infants | to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the second vaccination | 7 days after the second vaccination |
| GMT of antibody against group A, C polysaccharide meningitis in children after the vaccination | to evaluate the GMT of antibody against group A, C polysaccharide meningitis in children 4 weeks (28±3 days) after the vaccination | 4 weeks (28±3 days) after the vaccination |
| GMT of antibody against group A, C polysaccharide meningitis in infants after the infant series | to evaluate the GMT of antibody against group A, C polysaccharide meningitis in infants 4 weeks (28±3 days) after the infant series (two times, 28 day apart) | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) |
| GMT of antibody against type b haemophilus Influenza in serum in children after the vaccination | to evaluate the GMT of antibody against type b haemophilus Influenza in children 4 weeks (28±3 days) after the vaccination | 4 weeks (28±3 days) after the vaccination |
| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
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