NCT01362322

Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.

Detailed description

The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care. The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.

Conditions

• Diphtheria
• Tetanus
• Acellular Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix TM (new syringe presentation)	Single dose, intramuscular administration in a new syringe presentation
BIOLOGICAL	Boostrix TM (previous syringe presentation)	Single dose, intramuscular administration in previous syringe presentation

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-03
• Completion: 2012-09-03
• First posted: 2011-05-30
• Last updated: 2018-08-10
• Results posted: 2018-08-10

Locations

3 sites across 2 countries: Chile, Mexico