Status:
COMPLETED
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Meningococcal Meningitis
Eligibility:
All Genders
11-18 years
Phase:
PHASE4
Brief 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 compar...
Eligibility Criteria
Inclusion
- Individuals eligible for enrollment in this study were female and male individuals who had been shown to be healthy and who were:
- 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
- Had been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations;
- 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.
- For female subjects, who had a negative urine pregnancy test.
- Any female subject who is sexually active committed to practice appropriate birth control.
Exclusion
- Individuals not eligible to be enrolled in the study were those:
- Who were unwilling to give their written assent / consent
- Who were breastfeeding
- Who was, and/or whose parents or legal guardians were perceived to be unreliable or unavailable for the duration of the study period
- Who had previous confirmed or suspected disease caused by N. meningitidis
- Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment
- 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)
- Who had received prior human papillomavirus (HPV) vaccine
- 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
- 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)
- 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
- 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)
- Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome
- Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including latex allergy
- 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
- Who were 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;
- Who and/or whose families were planning to leave the area of the study site before the end of the study period;
- Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Who were relatives of the study personnel.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT01424644
Start Date
September 1 2011
End Date
December 1 2012
Last Update
February 14 2014
Active Locations (20)
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1
Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615
Birmingham, Alabama, United States, 35205
2
Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A
Fremont, California, United States, 68025
3
Madera Family Medical Group, 1111 W. Fourth Street
Madera, California, United States, 93637
4
Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road
Colorado Springs, Colorado, United States, 80922