Immunogenicity and Tolerability of V503 Versus GARDASIL - Full Text View

Purpose

Primary objective:

• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

To evaluate the tolerability of V503 in 9-15 year-old girls.
To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.

Condition	Intervention	Phase
Human Papillomavirus	Biological: 1 dose at Day 1, 1 dose at Month 2 and 1 dose at Month 6	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:

HPV 16 GMTs [ Time Frame: 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 18 GMTs [ Time Frame: 4 weeks post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HPV 6 seroprotection rate [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 11 seroprotection rate [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 16 seroprotection rate [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 18 seroprotection rate [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 6 GMTs [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 11 GMTs [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 16 GMTs [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
HPV 18 GMTs [ Time Frame: Pre-vaccination (Day 1) and 4 weeks post-dose 3 ] [ Designated as safety issue: No ]
Number and percentage of subjects with injection-site adverse reactions [ Time Frame: From Day 1 to Day 15 following each vaccination ] [ Designated as safety issue: Yes ]
Injection-site adverse reactions: solicited (redness, swelling, and pain/tenderness/soreness) or unsolicited
Number and percentage of subjects with systemic adverse events [ Time Frame: From Day 1 to Day 15 following each vaccination ] [ Designated as safety issue: Yes ]
Systemic adverse events: elevated temperature (≥37.8ºC) or other adverse events
Number and percentage of subjects with serious adverse events [ Time Frame: From informed consent signature to 1 month after last vaccination (Day 1 to Month 7) ] [ Designated as safety issue: Yes ]

Enrollment:	600
Study Start Date:	February 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: V503	Biological: 1 dose at Day 1, 1 dose at Month 2 and 1 dose at Month 6 1 dose 0.5 mL
Active Comparator: GARDASIL	Biological: 1 dose at Day 1, 1 dose at Month 2 and 1 dose at Month 6 1 dose 0.5 mL

Eligibility

Ages Eligible for Study:	9 Years to 15 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female from 9 to 15 years old.
Good physical health.

Exclusion Criteria:

Known allergy to any vaccine component.
History of severe allergic reaction.
Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
Pregnant subject.
Immunocompromised or immunodeficient subject.
Splenectomy.
Receipt of medication / vaccine that may interfere with study assessment.
Fever
History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
Any condition that might interfere with study assessment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304498

Locations

Belgium
Sanofi Pasteur MSD Investigational Site 0101
Antwerpen, Belgium
Sanofi Pasteur MSD Investigational Site 0103
Brussels, Belgium
Sanofi Pasteur MSD Investigational Site 0102
Leuven, Belgium
Denmark
Sanofi Pasteur MSD Investigational Site 0203
Arhus, Denmark
Sanofi Pasteur MSD Investigational Site 0201
Copenhagen, Denmark
Sanofi Pasteur MSD Investigational Site 0202
Hillerod, Denmark
Sanofi Pasteur MSD Investigational Site 0204
Odense, Denmark
Finland
Sanofi Pasteur MSD Investigational Site 0302
Helsinki, Finland
Sanofi Pasteur MSD Investigational Site 0303
Jarvenpaa, Finland
Sanofi Pasteur MSD Investigational Site 0305
Lahti, Finland
Sanofi Pasteur MSD Investigational Site 0306
Pori, Finland
Italy
Sanofi Pasteur MSD Investigational Site 0405
Brescia, Italy
Sanofi Pasteur MSD Investigational Site 0401
Genova, Italy
Sanofi Pasteur MSD Investigational Site 0402
Latisana, Italy
Sanofi Pasteur MSD Investigational Site 0404
Roma, Italy
Sanofi Pasteur MSD Investigational Site 0403
Sassari, Italy
Spain
Sanofi Pasteur MSD Investigational Site 0501
Barcelona, Spain
Sanofi Pasteur MSD Investigational Site 0502
Santiago de Compostela, Spain
Sanofi Pasteur MSD Investigational Site 0503
Valencia, Spain
Sanofi Pasteur MSD Investigational Site 0504
Valencia, Spain
Sanofi Pasteur MSD Investigational Site 0505
Valencia, Spain
Sweden
Sanofi Pasteur MSD Investigational Site 0602
Linkoping, Sweden
Sanofi Pasteur MSD Investigational Site 0603
Lund, Sweden
Sanofi Pasteur MSD Investigational Site 0601
Stockholm, Sweden
Sanofi Pasteur MSD Investigational Site 0604
Umea, Sweden
Sanofi Pasteur MSD Investigational Site 0605
Uppsala, Sweden

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

Marie WEHRLEN-GRANDJEAN, MD

Sanofi Pasteur MSD

More Information

No publications provided

Responsible Party:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT01304498 History of Changes
Other Study ID Numbers:	GDS01C
Study First Received:	February 24, 2011
Last Updated:	December 22, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on June 18, 2013