Group A, C Polysaccharide Meningitis, Type b Haemophilus Influenza
Conditions
Keywords
immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza, conjugate vaccine
Brief summary
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.
Interventions
BIOLOGICALA+C+hib Conjugate Vaccine
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
BIOLOGICALPlacebo
Placebo will be administered intramuscularly on the other arm, per 0.5ml dose
BIOLOGICALA+C Vaccine
The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose
BIOLOGICALHib vaccine
The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
Sponsors
Royal (Wuxi) Biological Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
For the children (aged from 2 to 5 years old) Inclusion Criteria: * Healthy subjects aged from 2 to 5 years old of normal intelligence. * The subjects' guardians are able to understand and sign the informed consent. * Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine. * Subjects who can comply with the requirements of the clinical trial program according to the researcher's views. * Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine. * Subjects with temperature \<37°C on axillary setting.
Exclusion criteria
* Subject who has a medical history of Meningitis; * Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on; * Subject who is allergic with tetanus toxoid components; * Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection; * Subject who has a history of allergic reactions; * Any known immunological dysfunction; * Had received gamma globulin or immune globulin, in the past two weeks * Subject suffering from congenital malformations, dysgenopathy or serious chronic disease; * Any acute infections * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives For the infants (aged from 6 to 23 months old) Inclusion Criteria: * Healthy subjects aged from 6 months to 23 months old of normal intelligence. * The subjects' guardians are able to understand and sign the informed consent. * Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine. * Subjects who can comply with the requirements of the clinical trial program according to the researcher's views. * Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine. * Subjects with temperature\<37°C on axillary setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate of antibody against group A, C polysaccharide meningitis in children after vaccination | 4 weeks (28±3 days) after the 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 |
| The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants after infant series | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) | 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). |
| The seroconversion rate of antibody against type b haemophilus influenza in children after the vaccination | 4 weeks (28±3 days) 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 |
| The seroconversion rate of antibody against type b haemophilus influenza in infants after infant series | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection-site reactions and systemic events after the vaccination in children | 7 days after the vaccination | to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy children for 7 days after the vaccination |
| Injection-site reactions and systemic events after the first vaccination in infants | 7 days after the first vaccination | to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the first vaccination |
| Injection-site reactions and systemic events after the second vaccination in infants | 7 days after the second vaccination | to evaluate the injection-site reactions and systemic events of the investigational vaccines in healthy infants for 7 days after the second vaccination |
| GMT of antibody against group A, C polysaccharide meningitis in children after the vaccination | 4 weeks (28±3 days) 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 |
| GMT of antibody against group A, C polysaccharide meningitis in infants after the infant series | 4 weeks (28±3 days) after the infant series (two times, 28 day apart) | 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) |
| GMT of antibody against type b haemophilus Influenza in serum in children after the vaccination | 4 weeks (28±3 days) after the vaccination | to evaluate the GMT of antibody against type b haemophilus Influenza in children 4 weeks (28±3 days) after the vaccination |
Countries
China
Outcome results
None listed