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

NCT ID: NCT01406509

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

0.5ml/dose for a person

Intervention Type: BIOLOGICAL

group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0

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

Group Type: EXPERIMENTAL

0.5ml/dose for a person

Intervention Type: BIOLOGICAL

group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28

Interventions

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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

• Had any Grade 3 or Grade 4 adverse reactions or events
• Any condition the investigator believed may affect the evaluation of the vaccine

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal (Wuxi) Biological Co., LTD

OTHER

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Fengcai Zhu

Professor, Director of Center for Vaccine Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

JSVCT006

Identifier Type: -

Identifier Source: org_study_id