Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royal (Wuxi) Biological Co., LTD | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A+C+hib Conjugate Vaccine | Experimental | 600 infants aged 3-5 months, will be vaccinated on day0, 28, 56 |
|
| Walvax AC vaccine, Pasteur Hib vaccine | Active Comparator | 300 infants aged 3-5 months, will be vaccinated on day0, 28, 56 |
|
| 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 on one arm, intramuscularly, per 0.5ml dose |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months | the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart). | 4 weeks (28±3 days) after the infant series |
| The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months | the seroconversion rate of antibody against type b haemophilus Influenza in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart) | 4 weeks (28±3 days) after the infant series |
| Measure | Description | Time Frame |
|---|---|---|
| adverse reactions after the first vaccination in infants aged 3-5 months | adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the first vaccination | 7 days after the first vaccination |
| adverse reactions after the second vaccination in infants aged 3-5 months |
Not provided
Inclusion Criteria:
Exclusion Criteria for the first vaccination:
Exclusion Criteria for the second or third vaccination:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Funing county Center for Disease Control and Prevention | Yancheng | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose |
|
| A+C Vaccine | Biological | The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology 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 |
|
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the second vaccination |
| 7 days after the second vaccination |
| adverse reactions after the third vaccination in infants aged 3-5 months | adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the third vaccination | 7 days after the third vaccination |
| GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months | GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart) | 4 weeks (28±3 days) after the infant series |
| GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months | GMT of antibody against type b haemophilus Influenza in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart) | 4 weeks (28±3 days) after the infant series |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
Not provided
Not provided
Not provided