Status:
COMPLETED
Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Royal (Wuxi) Biological Co., LTD
Conditions:
Group A, C Polysaccharide Meningitis
Type b Haemophilus Influenza
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
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
- For the children (aged from 2 to 5 years old)
- 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
- 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.
- Exclusion Criteria for the first vaccination:
- 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 vaccination:
- Had any Grade 3 or Grade 4 adverse reactions or events occurred since the first vaccination
- 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 :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
2394 Patients enrolled
Trial Details
Trial ID
NCT01428908
Start Date
September 1 2011
End Date
January 1 2012
Last Update
April 19 2012
Active Locations (1)
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1
Funing county Center for Disease Control and Prevention
Funing County, Jiangsu, China, 224400