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

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)

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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