A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
11 Years
18 Years
Both
Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
Trial Information
A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
Inclusion Criteria:
- Healthy adolescents 11-18 years of age
- virgins (both male and female) with no intention of becoming sexually active during
the study period
- who have been properly vaccinated against diphtheria, tetanus, pertussis
Exclusion Criteria:
- who had a previous confirmed or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine
- who have received prior human papillomavirus (HPV) vaccine;
- who have any serious acute, chronic or progressive disease
- who have epilepsy, any progressive neurological disease or history of Guillain-Barre
syndrome;
- who have a known or suspected impairment/alteration of immune function, either
congenital or acquired
- who are known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time;
- who have Down's syndrome or other known cytogenic disorders;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Percentage of Subjects With hSBA Seroresponse
Outcome Description:
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tdap vaccine and a HPV vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome Time Frame:
1 month postvaccination
Safety Issue:
No
Principal Investigator
Novartis Vaccines and Diagnostics
Investigator Role:
Study Director
Investigator Affiliation:
Novartis
Authority:
United States: Food and Drug Administration
Study ID:
V59P18
NCT ID:
NCT00518180
Start Date:
July 2007
Completion Date:
October 2008
Related Keywords:
- Meningococcal Meningitis
- Human Papillomavirus Infection
- Pertussis
- Tetanus
- Meningococcal
- meningitis
- vaccine
- adolescents
- Meningitis
- Meningitis, Meningococcal
- Whooping Cough
- Tetanus
- Tetany
- Warts
- Papillomavirus Infections
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