The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12‑14 months and 3‑5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

Condition	Intervention	Phase
Meningitis, Meningococcal	Vaccine: Meningococcal vaccine	Phase II

Further Study Details: 

Primary Outcomes: Percentage of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e. 4-fold increase in serum bactericidal antibody [SBA] titre from pre to post vaccination) at 1 month after the first vaccine dose
Secondary Outcomes: Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster; Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)
Expected Total Enrollment:  500

Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.

Ages Eligible for Study:  12 Months   -   14 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Healthy male or female between, and including, 12 and 14 months or 3 and 5 years (36 to 60 months) of age at the time of the first vaccination.
• Subject should have previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge (for pertussis vaccination, the subjects aged 12-14 months should have been vaccinated with an acellular pertussis vaccine).

Exclusion Criteria:

• Previous vaccination against OR history of OR exposure to meningococcal serogroup A, C, W-135 or Y disease.
• Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
• For subjects aged 12-14 months at enrolment, a DTPa/Hib containing booster vaccination, in the second year of life; these booster vaccines will be given at Visit 2.
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00126984

Clinical Coordinator      1-877-379-37-18 

Austria
      Wien,  Austria; Recruiting
Poland
      Kravov,  Poland; Recruiting

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  104703
Last Updated:  August 19, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00126984
Health Authority: Australia: Human Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-23