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

PHASE4CompletedINTERVENTIONAL
Enrollment

801

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Meningococcal Meningitis
Interventions
BIOLOGICAL

Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine

"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®."

BIOLOGICAL

MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine

"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®."

Trial Locations (20)

16132

"HOSPITALSAN MARTINO. Department of Health Sciences University of Genoa", Via Pastore, 1

21045

Columbia Medical Practice, 5450 Knoll North Drive, Suite 215, Columbia

27609

Capitol Pediatrics and Adolescent Center, 3801 Computer Drive Suite 200, Raleigh

28100

"Hospital Maggiore della Carità. Pediatric Clinic", Corso Mazzini, 18

30062

Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100, Marietta

30189

Pediatrics and Adolescent Medicine, 120 Stonebridge Parkway, Suite 410, Woodstock

32746

Altamonte Pediatric Associates, 101 N. Country Club Rd. #113, Lake Mary

35205

Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615, Birmingham

45406

Dayton Clinical Research, 1100 Salem Ave, Dayton

45424

Ohio Pediatric Research Association, 7371 Brandt Pike Suite C, Huber Heights

51503

Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201, Council Bluffs

68005

Bellevue Family Practice, 2206 Longo Suite 201, Bellevue

68025

Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A, Fremont

68134

Meridian Clinical Research, 3319 North, 107th Street, Omaha

68505

Complete Children's Health, 8201 Northwoods Drive, Lincoln

74016

Hospital of Taranto- Unit of Hygiene and Publich Health Vaccination Center, Viale Magna Grecia, 173

80922

Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road, Colorado Springs

93637

Madera Family Medical Group, 1111 W. Fourth Street, Madera

02130

Roslindale Pediatrics Associates, 1153 Centre Street, Suite 31, Boston

02886

Omega Medical Research, 400 Bald Hill Road, Warwick

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY