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

Completed · Phase 4 · Has a placebo group

Conditions studied: Meningococcal Meningitis

In brief

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.

Key facts

Study ID

NCT01424644

Run by

Novartis

People needed

801

Starts

2011-09-01

Expected to finish

2012-12-01

Last updated by the study team

2014-02-14

Who can join

Age: 11 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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):

Where it is running

• Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615 — Birmingham, Alabama, United States
• Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A — Fremont, California, United States
• Madera Family Medical Group, 1111 W. Fourth Street — Madera, California, United States
• Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road — Colorado Springs, Colorado, United States
• Dayton Clinical Research, 1100 Salem Ave — Dayton, Florida, United States
• Altamonte Pediatric Associates, 101 N. Country Club Rd. #113 — Lake Mary, Florida, United States
• Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100 — Marietta, Georgia, United States
• Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201 — Council Bluffs, Iowa, United States
• Columbia Medical Practice, 5450 Knoll North Drive, Suite 215 — Columbia, Maryland, United States
• Roslindale Pediatrics Associates, 1153 Centre Street, Suite 31 — Boston, Massachusetts, United States
• Bellevue Family Practice, 2206 Longo Suite 201 — Bellevue, Nebraska, United States
• Complete Children's Health, 8201 Northwoods Drive — Lincoln, Nebraska, United States
• Meridian Clinical Research, 3319 North, 107th Street — Omaha, Nebraska, United States
• Pediatrics and Adolescent Medicine, 120 Stonebridge Parkway, Suite 410 — Woodstock, New York, United States
• Capitol Pediatrics and Adolescent Center, 3801 Computer Drive Suite 200 — Raleigh, North Carolina, United States
• Ohio Pediatric Research Association, 7371 Brandt Pike Suite C — Huber Heights, Ohio, United States
• Omega Medical Research, 400 Bald Hill Road — Warwick, Rhode Island, United States
• HOSPITAL"SAN MARTINO". Department of Health Sciences University of Genoa — Via Pastore, 1, Genoa, Italy
• Hospital "Maggiore della Carità". Pediatric Clinic — Corso Mazzini, 18, Novara, Italy
• Hospital of Taranto- Unit of Hygiene and Publich Health Vaccination Center — Viale Magna Grecia, 173, Taranto, Italy

Full record on ClinicalTrials.gov

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