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

B

Beijing Center for Disease Prevention and Control

Status and phase

Completed
Phase 4

Conditions

Healthy

Treatments

Biological: Inoculation in upper arm deltoid
Biological: Inoculation in vastus lateralis muscle

Study type

Interventional

Funder types

Other

Identifiers

NCT01761136
BJCDPC-4

Details and patient eligibility

About

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

Full 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.

Enrollment

680 patients

Sex

All

Ages

2 to 12 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

680 participants in 2 patient groups

Inoculation in upper arm deltoid
Active Comparator group
Description:
Inoculation of Hib vaccine of two brands in upper arm deltoid
Treatment:
Biological: Inoculation in vastus lateralis muscle
Biological: Inoculation in upper arm deltoid
Inoculation in vastus lateralis muscle
Experimental group
Description:
Inoculation of Hib vaccine of two brands in vastus lateralis muscle
Treatment:
Biological: Inoculation in vastus lateralis muscle
Biological: Inoculation in upper arm deltoid

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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