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Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00323050
First received: August 26, 2005
Last updated: May 21, 2009
Last verified: May 2009
History of Changes

August 26, 2005
May 21, 2009
November 2004
Not Provided
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ⠥ 1µg/ml and % of subjects with SBA-MenC titers ⠥ 128 one month post vaccination.
Complete list of historical versions of study NCT00323050 on ClinicalTrials.gov Archive Site
  • Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128
  • Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3
  • Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.
  • SAEs for whole study
Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP â ¥ 1,-PSC â ¥ 2, SBA-MenC â ¥ 128. Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3. Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc. SAEs fo
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Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Mths Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.

The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b Disease
  • Meningococcal Serogroup Diseases
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
Other Name: Haemophilus influenzae type b- and meningococcal (vaccine)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
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Inclusion criteria:

  • Healthy male or female between, and including, 13 and 14 months of age
  • Having participated in the primary vaccination study 217744/097.

Exclusion criteria:

  • Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • A family history of congenital or hereditary immunodeficiency
  • History of any neurologic disorders or seizures
Both
13 Months to 14 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00323050
102547
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2009

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