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

March 27, 2013 updated by: Beijing Center for Disease Control and Prevention

Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

680

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibody titre of Haemophilus influenzae type b vaccine in different injection site
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Center for Disease Control and Prevention

Investigators

  • Principal Investigator: nianmin shi, Beijing chaoyang district center for disease control and prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • BJCDPC-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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