NCT00471081

Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 9 Months – 9 Months
• Healthy volunteers: Accepted

Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Detailed description

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion \& Exclusion criteria.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	One or 2 intramuscular injections.

Timeline

• Start date: 2007-07-05
• Primary completion: 2008-10-23
• Completion: 2008-11-26
• First posted: 2007-05-09
• Last updated: 2019-06-25
• Results posted: 2018-09-14

Locations

19 sites across 1 country: United States