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Completed

NCT Number: NCT01761136

The Safety and Immunogenicity 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.

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Key information

Conditions

Healthy

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Huaxin Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inoculation in upper arm deltoid

Biological

Inoculation of Hib vaccine of two brands in upper arm deltoid

Inoculation in vastus lateralis muscle

Biological

Inoculation of Hib vaccine of two brands in vastus lateralis muscle

Primary outcomes

  1. Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site

    Time frame: one year

Secondary outcomes

  1. Antibody titre of Haemophilus influenzae type b vaccine in different injection site

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Beijing Center for Disease Control and Prevention

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 4, 2013
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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