Healthy
Conditions
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.
Interventions
BIOLOGICALInoculation in upper arm deltoid
Inoculation of Hib vaccine of two brands in upper arm deltoid
BIOLOGICALInoculation in vastus lateralis muscle
Inoculation of Hib vaccine of two brands in vastus lateralis muscle
Sponsors
Beijing Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site | one year |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titre of Haemophilus influenzae type b vaccine in different injection site | one year |
Countries
China
Outcome results
None listed