NCT00196976

Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 60 Months
• Healthy volunteers: Accepted

Summary

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. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. 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. The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens. Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Conjugated meningococcal ACWY-TT (vaccine)	One intramuscular dose during the primary vaccination
BIOLOGICAL	DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)	One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
BIOLOGICAL	DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)	One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
BIOLOGICAL	Meningitec™	One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
BIOLOGICAL	Mencevax™ACWY	One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)

Timeline

• Start date: 2005-03-24
• Primary completion: 2006-03-01
• Completion: 2006-03-03
• First posted: 2005-09-20
• Last updated: 2018-06-08
• Results posted: 2017-03-01

Locations

17 sites across 2 countries: Austria, Greece