The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site
Phase 4
Completed
- Conditions
- Healthy
- Interventions
- Biological: Inoculation in upper arm deltoidBiological: Inoculation in vastus lateralis muscle
- Registration Number
- NCT01761136
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 680
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inoculation in upper arm deltoid Inoculation in upper arm deltoid Inoculation of Hib vaccine of two brands in upper arm deltoid Inoculation in upper arm deltoid Inoculation in vastus lateralis muscle Inoculation of Hib vaccine of two brands in upper arm deltoid Inoculation in vastus lateralis muscle Inoculation in upper arm deltoid Inoculation of Hib vaccine of two brands in vastus lateralis muscle Inoculation in vastus lateralis muscle Inoculation in vastus lateralis muscle Inoculation of Hib vaccine of two brands in vastus lateralis muscle
- Primary Outcome Measures
Name Time Method Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site one year
- Secondary Outcome Measures
Name Time Method Antibody titre of Haemophilus influenzae type b vaccine in different injection site one year
Trial Locations
- Locations (5)
Beijing Dongba Hospital
🇨🇳Beijing, China
Cuigezhuang community health service centers
🇨🇳Beijing, China
Beijing Huaxin Hospital
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Women's and Children's Hospital
🇨🇳Beijing, China
Xiaohongmen community health service centers
🇨🇳Beijing, China