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Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

NCT ID: NCT01304498

Last Updated: 2018-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-23

Study Completion Date

2011-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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V503

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Group Type EXPERIMENTAL

V503

Intervention Type BIOLOGICAL

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine

GARDASIL

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Group Type ACTIVE_COMPARATOR

GARDASIL

Intervention Type BIOLOGICAL

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine

Interventions

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V503

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine

Intervention Type BIOLOGICAL

GARDASIL

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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9vHPV vaccine qHPV vaccine

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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Belgium Denmark Finland Italy Spain Sweden

References

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Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, Tran C, Thomas S, Luxembourg A, Baudin M. A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil(R) in 9-15-Year-Old Girls. Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773.

Reference Type RESULT
PMID: 26090572 (View on PubMed)

Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.

Reference Type DERIVED
PMID: 27422279 (View on PubMed)

Other Identifiers

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GDS01C

Identifier Type: OTHER

Identifier Source: secondary_id

2010-023393-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V503-009

Identifier Type: -

Identifier Source: org_study_id