Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children

This study has been completed.

Sponsor:

Collaborator:

Royal (Wuxi) Biological Co., LTD

Information provided by (Responsible Party):

Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT01406509

First received: July 26, 2011

Last updated: April 17, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 26, 2011
Last Updated Date	April 17, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 29, 2011)	The adverse reactions in healthy children (2-5 years) after the first vaccination [ Time Frame: 7 days after the first vaccination ] [ Designated as safety issue: Yes ] 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 [ Time Frame: 7 days after the first vaccination ] [ Designated as safety issue: Yes ] 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 [ Time Frame: 7 days after the second vaccination ] [ Designated as safety issue: Yes ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01406509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
Official Title ^ICMJE	A Phase I Clinical Trial for Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Biological: 0.5ml/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 Biological: 0.5ml/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, 28
Study Arm (s)	Experimental: children aged 2-5 years (1 dose) group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 2-5 years, on day 0 Intervention: Biological: 0.5ml/dose for a person Experimental: children aged 6-23months (2 doses) group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 6-23 months old, on day 0, 28 Intervention: Biological: 0.5ml/dose for a person
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	December 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 Exclusion Criteria: 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
Gender	Both
Ages	6 Months to 5 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01406509
Other Study ID Numbers ^ICMJE	JSVCT006
Has Data Monitoring Committee	No
Responsible Party	Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
Study Sponsor ^ICMJE	Jiangsu Province Centers for Disease Control and Prevention
Collaborators ^ICMJE	Royal (Wuxi) Biological Co., LTD
Investigators ^ICMJE	Not Provided
Information Provided By	Jiangsu Province Centers for Disease Control and Prevention
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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