Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 187 for:    "Haemophilus influenzae"

The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00197782
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Public Health England

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date August 24, 2018
Study Start Date  ICMJE April 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00197782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine
Official Title  ICMJE Not Provided
Brief Summary To measure the magnitude and persistence of the antibody response to a booster dose of Hib conjugate vaccine given between 9 months and 4 years of age to UK children who had completed primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Haemophilus Influenzae Type b
Intervention  ICMJE Biological: Hib conjugate vaccine
Study Arms Not Provided
Publications * Southern J, McVernon J, Gelb D, Andrews N, Morris R, Crowley-Luke A, Goldblatt D, Miller E. Immunogenicity of a fourth dose of Haemophilus influenzae type b (Hib) conjugate vaccine and antibody persistence in young children from the United Kingdom who were primed with acellular or whole-cell pertussis component-containing Hib combinations in infancy. Clin Vaccine Immunol. 2007 Oct;14(10):1328-33. Epub 2007 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent from parent or legal guardian of the infant or child
  • Age >= 9 months and <4 years at recruitment
  • Eligible to receive a single dose of Hib vaccine as per the UK schedule
  • Receipt of three doses of Hib vaccine in infancy

Exclusion Criteria:

  • History of Hib infection
  • History of severe local reaction that can be confidently related to a prior Hib immunisation
  • Deferral of vaccination if acute illness and/or temperature >38C on day of vaccination
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Months to 4 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00197782
Other Study ID Numbers  ICMJE Hibboost
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Elizabeth Miller, Public Health England
Study Sponsor  ICMJE Public Health England
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth Miller, MBBS FRCPath Public Health England
PRS Account Public Health England
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP