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The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site

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ClinicalTrials.gov Identifier: NCT01761136
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention

Brief Summary:
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

Condition or disease Intervention/treatment Phase
Healthy Biological: Inoculation in upper arm deltoid Biological: Inoculation in vastus lateralis muscle Phase 4

Detailed Description:
A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Inoculation in upper arm deltoid
Inoculation of Hib vaccine of two brands in upper arm deltoid
Biological: Inoculation in upper arm deltoid
Inoculation of Hib vaccine of two brands in upper arm deltoid

Biological: Inoculation in vastus lateralis muscle
Inoculation of Hib vaccine of two brands in vastus lateralis muscle

Experimental: Inoculation in vastus lateralis muscle
Inoculation of Hib vaccine of two brands in vastus lateralis muscle
Biological: Inoculation in upper arm deltoid
Inoculation of Hib vaccine of two brands in upper arm deltoid

Biological: Inoculation in vastus lateralis muscle
Inoculation of Hib vaccine of two brands in vastus lateralis muscle




Primary Outcome Measures :
  1. Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Antibody titre of Haemophilus influenzae type b vaccine in different injection site [ Time Frame: one year ]


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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participants were under 1 years old, and were in good healthy
  • participants were full-time pregnancy and birth weight were more than 2.5 kg

Exclusion Criteria:

  • current infectious fever or acute disease
  • a history of hypersensitivity to study vaccine components especially tetanus toxoid
  • a history of allergy, autoimmune, convulsions, seizures heredity disease
  • a history of Hib vaccination or Hib disease
  • a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761136


Locations
China, Beijing
Beijing Huaxin Hospital
Beijing, Beijing, China
China
Beijing Chaoyang Women's and Children's Hospital
Beijing, China
Beijing Dongba Hospital
Beijing, China
Cuigezhuang community health service centers
Beijing, China
Xiaohongmen community health service centers
Beijing, China
Sponsors and Collaborators
Beijing Center for Disease Control and Prevention
Investigators
Principal Investigator: Nianmin Shi Beijing Chaoyang District Center for Disease Control and Prevention

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01761136     History of Changes
Other Study ID Numbers: BJCDPC-4
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs