Healthy
Conditions
Keywords
Safety, 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, 90-99% of children will produce antibody of protection after 3 doses. 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. 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
BIOLOGICAL0.5ml/dose for a person
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0
Sponsors
Royal (Wuxi) Biological Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects aged from 6 months to 5years 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 experimental 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 adverse reactions in healthy children (2-5 years) after the first vaccination | 7 days after the first vaccination | to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (2-5 years) after the first vaccination |
| The adverse reactions in healthy children (6-23 months) after the first vaccination | 7 days after the first vaccination | to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the first vaccination |
| The adverse reactions in healthy children (6-23 months) after the second vaccination | 7 days after the second vaccination | to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the second vaccination |
Countries
China
Outcome results
None listed