Group A, C Polysaccharide Meningitis Clinical Trial
Official title:
A Phase III Clinical Trial the Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention