Status:
COMPLETED
Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Royal (Wuxi) Biological Co., LTD
Conditions:
Healthy
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusion Criteria for the first dose:
- 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
- Exclusion Criteria for the second dose:
- Had any Grade 3 or Grade 4 adverse reactions or events
- Any situation meets the exclusion criteria stated in the exclusion criteria for first dose
- Any condition the investigator believed may affect the evaluation of the vaccine
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01406509
Start Date
August 1 2011
End Date
December 1 2011
Last Update
April 19 2012
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009