Influenza Clinical Trial
Official title:
Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Aged 3-5 Months: A Phase 3 Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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