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

NCT01406509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-04-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Royal (Wuxi) Biological Co., LTD

    collaborator OTHER

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406509 on ClinicalTrials.gov