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Completed

NCT Number: NCT00323050

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

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.

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Key information

Conditions

Neisseria Meningitidis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Infections Pasteurellaceae Infections

Age range

13 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Alcorcón, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Haemophilus influenzae type b- and meningococcal (vaccine)

Biological

Primary outcomes

  1. Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.

Secondary outcomes

  1. Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128

  2. Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3

  3. Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.

  4. SAEs for whole study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
May 9, 2006
Registry last updated
Sep 16, 2016

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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