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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01761136
First received: January 3, 2013
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Healthy
Biological: Inoculation in upper arm deltoid
Biological: Inoculation in vastus lateralis muscle
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site

Resource links provided by NLM:


Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody titre of Haemophilus influenzae type b vaccine in different injection site [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 680
Study Start Date: November 2011
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Months to 12 Months
Genders Eligible for Study:   Both
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.
  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: NCT01761136

Locations
China, Beijing
Beijing Huaxin Hospital
Beijing, Beijing, China
China
Xiaohongmen community health service centers
Beijing, China
Beijing Dongba Hospital
Beijing, China
Beijing Chaoyang Women's and Children's Hospital
Beijing, China
Cuigezhuang 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
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01761136     History of Changes
Other Study ID Numbers: BJCDPC-4
Study First Received: January 3, 2013
Last Updated: March 27, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014