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

NCT01304498 | Completed Phase 3 Results

• 3 other identifiers: V503-009GDS01C2010-023393-39
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) to HPV Types 16 and 18

  Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.

  4 weeks postdose 3 (Month 7)

Secondary Outcomes (7)

• GMTs to HPV Types 6 and 11

  4 weeks postdose 3 (Month 7)

• Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18

  4 weeks postdose 3 (Month 7)

• Percentage of Participants With One or More Adverse Events

  Up to Month 7

• Percentage of Participants With One or More Injection-site Adverse Reactions

  Up to 5 days after any vaccination

• Percentage of Participants With One or More Systemic Adverse Events

  Up to 15 days after any vaccination

Study Arms (2)

V503

EXPERIMENTAL

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

Biological: V503

GARDASIL

ACTIVE COMPARATOR

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

Biological: GARDASIL

Interventions

V503 BIOLOGICAL

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

Also known as: 9vHPV vaccine

V503

GARDASIL BIOLOGICAL

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

Also known as: qHPV vaccine

GARDASIL

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• 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.

  PMID: 26090572 RESULT

• 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.

  PMID: 27422279 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: February 23, 2011
• Primary Completion: December 20, 2011
• Study Completion: December 20, 2011
• Last Updated: December 14, 2018
• Results First Posted: August 22, 2017

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share