US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

A phase IV, randomized, partially blinded multicenter study to evaluate the safety and
immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] co-administered
intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135)
polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the
administration of either vaccine alone in healthy adolescents 11-18 years of age.
"Experimental design: Prospective, randomized, controlled multicenter study with three
groups:

Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix
on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3:
Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2
Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study:
Approximately one month for each subject in Group 1 and approximately two months for each
subject in the Group 2 and Group 3."

Inclusion Criteria:

- Healthy subjects as established by medical history and history-directed physical
examination before entering into the study.

- Previously completed routine childhood vaccinations against diphtheria, tetanus and
pertussis diseases according to the recommended vaccination schedule at the time.

- Females of childbearing potential at the time of study entry are required to have a
negative pregnancy test prior to administration of the dose of vaccine and are
required to be abstinent or use adequate contraceptive precautions for one month prior
to vaccination. Subjects also are required to agree to continue such precautions for
two months after vaccination.

Exclusion Criteria:

- Administration of a pre-school booster of DTP vaccine within the previous 5 years

- Administration of a diphteria-tetanus (Td) booster within the previous 5 years

- Previous vaccination against N. meningitidis

- Hypersensitivity to latex

- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus
toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study
vaccines

- History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged
seizures) within seven days of administration of a previous dose of pertussis vaccine
taht is not attributable to another identifiable cause

- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy:
pertussis vaccine should not be administered to individuals with these conditions
until a treatment regimen has been established and the condition has stabilized

- Previous history of Guillain-Barré syndrome