A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents

Exclusion Criteria

• •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
• •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.