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
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: 0.5ml/dose for a person
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Clinical Trial for Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406509

Locations
China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Royal (Wuxi) Biological Co., LTD
  More Information

No publications provided

Responsible Party: Fengcai Zhu, Professor, Director of Center for Vaccine Clinical Trials, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01406509     History of Changes
Other Study ID Numbers: JSVCT006
Study First Received: July 26, 2011
Last Updated: April 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety
Conjugate vaccine

ClinicalTrials.gov processed this record on September 18, 2014