A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine; MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
Intervention description: All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.; All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 801.0
Sex: All
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningitis; human papillomavirus; tetanus; diptheria; pertussis

Summary:

      The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline,
      Boostrix®) and HPV vaccine (Merck & Co., Inc., Gardasil®) when administered concomitantly
      with MenACWY are comparable to responses elicited by these vaccines when given alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment in this study were female and male individuals who had
        been shown to be healthy and who were:

          1. 11-18 years of age inclusive who had given their written consent/assent and if
             applicable, whose parents or legal guardians had given written informed consent at the
             time of enrollment;

               -  Available for all visits and telephone calls scheduled for the study;

               -  In good health as determined by:

                    -  Medical history

                    -  Physical assessment

                    -  Clinical judgment of the investigator

          2. Had been properly vaccinated against diphtheria, tetanus, and pertussis per local
             regulations;

          3. Subjects who were current with childhood DTP-containing vaccinations per local
             guidelines. Any previous vaccinations containing DTP must have been received at least
             5 years before study enrollment and no prior adolescent vaccinations (11-18 years of
             age) containing DTP vaccines were allowed.

          4. For female subjects, who had a negative urine pregnancy test.

          5. Any female subject who is sexually active committed to practice appropriate birth
             control.

        Exclusion Criteria:

        Individuals not eligible to be enrolled in the study were those:

          1. Who were unwilling to give their written assent / consent

          2. Who were breastfeeding

          3. Who was, and/or whose parents or legal guardians were perceived to be unreliable or
             unavailable for the duration of the study period

          4. Who had previous confirmed 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 had previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s) (licensed or investigational). (Exception: Receipt of
             OMP-containing Hib vaccines was permitted)

          7. Who had received prior human papillomavirus (HPV) vaccine

          8. Who had received investigational agents or vaccines within 30 days prior to enrollment
             or who expected to receive an investigational agent or vaccine prior to completion of
             the study

          9. Who had received live licensed vaccines within 30 days and inactive vaccine within 15
             days prior to enrollment or for whom receipt of a licensed vaccine is anticipated
             during the study period.

             (Exception: Influenza vaccine could be administered up to 15 days prior to each study
             immunization and no less than 15 days after each study vaccination)

         10. Who had experienced, within the 7 days prior to enrollment, significant acute or
             chronic infection (for example requiring systemic antibiotic treatment or antiviral
             therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days
             prior to enrollment

         11. Who had any serious acute, chronic or progressive disease such as

               -  History of cancer

               -  Complicated diabetes mellitus

               -  Advanced arteriosclerotic disease

               -  Autoimmune disease

               -  HIV infection or AIDS

               -  Blood dyscrasias

               -  Congestive heart failure

               -  Renal failure

               -  Severe malnutrition (Note: Subjects with mild asthma were eligible for
                  enrollment. Subjects with moderate or severe asthma requiring routine use of
                  inhaled or systemic corticosteroids were not eligible for enrollment)

         12. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre
             syndrome

         13. Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine
             component, including latex allergy

         14. Who had a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from (for example):

               -  Receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic
                  corticosteroids 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)

               -  Receipt of immunostimulants

               -  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 were 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 and/or whose families were planning to leave the area of the study site before the
             end of the study period;

         18. Who had any condition that, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives.

         19. Who were relatives of the study personnel.