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Completed

NCT Number: NCT00135564

Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers

The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.

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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The study is an extension of the primary vaccination study 711202/001 (MenC-TT-001). It comprises 5 groups: 4 parallel groups of toddlers vaccinated in study 711202/001 (group vaccinated with Meningitec™ is control group 1) and 1 group of naive subjects (no previous vaccination against MenC disease, control group 2). All subjects receive 1/5th dose Mencevax™ ACWY and a concomitant dose of Infanrix hexa®. 2 blood samples: prior to and 1 month after vaccination.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment

Exclusion criteria

  • Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
  • Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
  • 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, of allergic disease/reactions likely to be exacerbated by any component of the vaccines

Treatment and study plan

MenC-TT

Biological

Hib-MenC-TT

Biological

Primary outcomes

  1. Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups

Secondary outcomes

  1. Prior to dose 1, 1 m post doses 2, 3: anti-PRP

  2. Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN

  3. Solicited (days [d] 0-7), unsolicited (up to 30 d) adverse events (AEs) after each dose

  4. Serious adverse events (SAEs)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate the Persistence and Immune Memory Induced by a Primary Vaccination Course With GSK Biologicals' MenC-TT (1 Formulation) & GSK Biologicals' Hib-MenC-TT (2 Formulations) or Meningitec™ in Healthy Toddlers Aged 12-15 Months Primed in Study 711202/001

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Aug 26, 2005
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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