A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis Tdap Vaccine GSK Boostrix and Chiron Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Boostrix, Or One Dose of Chiron Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years - ND
- Conditions
- Active profilaxys against Neisseria Mengitidis type A, C, W, YMedDRA version: 6.1Level: PTClassification code 10027249
- Registration Number
- EUCTR2005-005519-12-IT
- Lead Sponsor
- CHIRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
1. 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment; OR 18-25 years of age, mentally competent, and able to give the written informed consent prior to study entry 2. available for all visits and telephone calls scheduled for the study 3. in good health as determined by o medical history o physical assessment o clinical judgment of the investigator 4. who have received the primary immunization with a vaccine containing DT or DTaP antigens and a T, Td or Tdap booster dose at least 5 years prior to study entry.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. who are unwilling to give their written assent subjects aged 11-17 years , when applicable 2. who subjects aged 18-25 years or whose parents or legal guardians for subjects aged 11-17 years are unwilling or unable to give written informed consent to participate in the study; 3. who and/or whose parents or legal guardians are perceived to be unreliable or unavailable for the duration of the study period; 4. who had a previous ascertained or suspected disease caused by N. meningitidis; 5. who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrollment; 6. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen s licensed or investigational Exception Receipt of OMP-containing Hib vaccines is permitted ; 7. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study; 8. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within study period Exception Influenza vaccine may be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination ; 9. who have received a live viral vaccine within 60 days prior to enrollment; 10. who have experienced within the 7 days prior to enrollment significant acute or chronic infection for example requiring systemic antibiotic treatment or antiviral therapy or have experienced fever e.g., axillary temperature 38 C within 3 days prior to enrollment; 11. who have any serious acute, chronic or progressive disease e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition . Exception Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment ; 12. who have epilepsy or any progressive neurological disease; 13. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component; 14. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from for example o receipt of immunosuppressive therapy within 30 days prior to enrollment any systemic corticosteroid administered for more than 5 days, or in a daily dose 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy o receipt of immunostimulants o receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 90 days prior to enrollment and for the full length of the study 15. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 16. who have Down s syndrome or other known cytogenic disorders; 17. who are pregnant or unwilling to do a pregnancy test or attest to not being pregnant; 18. who are not taking or unwilling to take sufficient measures to avoid pregnancy occurring for the duration of the study period. If sexually active, the subject must have been using one of the accepted birth control methods at least two months prior
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method