A Phase IV,PlaceboControlled,Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18]Recombinant Vaccine (Gardasil) in Healthy Adolescents when Administered with MenACWY Conjugate Vaccine

OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 sites800 target enrollmentMarch 20, 2012

ConditionsMenveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1Level: LLTClassification code 10027276Term: Meningococcal meningitisSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsMENVEO*IM 1FL+1FL 0,5ML

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Menveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.
Sponsor: OVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Enrollment: 800
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 20, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OVARTIS VACCINES AND DIAGNOSTICS S.R.L.

Eligibility Criteria

Inclusion Criteria

•1\. 11\-18 years of age inclusive who have given their written consent/assent and if applicable, whose parents or legal guardians have 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\. have been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations; 3\. Subjects should be current with childhood DTP\-containing vaccinations per local guidelines. Any previous vaccinations containing DTP should be at least 5 years before study enrollment and no prior adolescent vaccinations (11\-18 years of age) vaccines containing DTP are allowed 4\. for female subjects, have a negative urine pregnancy test. 5\. any female subject who is sexually active must commit to practice appropriate birth control.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\.who are unwilling to give their written assent / consent 2\.who are breastfeeding 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 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 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 prior human papillomavirus (HPV) vaccine 8\. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study 9\. who have 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 may be administered up to 15 days prior to each studyimmunization and no less than 15 days after each study immunization.) 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 (defined as body temperature \`?¥ 38°C) within 3 days prior to enrollment 11\.who have 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 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, any progressive neurological disease or history of Guillain\-Barre syndrome 13\. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including latex allergy 14\. who have 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 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 and/or whose families are planning to leave the area of the study site before the end of the study period; 18\. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 19\. who are relatives of the study personnel.