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

• ClinicalTrials.gov Identifier: NCT01304498
• Recruitment Status: Completed
• First Posted: February 25, 2011
• Results First Posted: August 22, 2017
• Last Update Posted: December 14, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Human Papillomavirus	Biological: V503; Biological: GARDASIL	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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)
• Actual Study Start Date: February 23, 2011
• Actual Primary Completion Date: December 20, 2011
• Actual Study Completion Date: December 20, 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Biological: V503; 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine; Other Name: 9vHPV vaccine
Active Comparator: 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	Biological: GARDASIL; Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine; Other Name: qHPV vaccine

Outcome Measures

Primary Outcome Measures :

1. Geometric Mean Titers (GMTs) to HPV Types 16 and 18 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
   Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.

Secondary Outcome Measures :

1. GMTs to HPV Types 6 and 11 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
   Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.
2. Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
   Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.
3. Percentage of Participants With One or More Adverse Events [ Time Frame: Up to Month 7 ]
   An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.
4. Percentage of Participants With One or More Injection-site Adverse Reactions [ Time Frame: Up to 5 days after any vaccination ]
   The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.
5. Percentage of Participants With One or More Systemic Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
   The percentage of participants with one or more systemic adverse events was assessed.
6. Percentage of Participants With Maximum Oral Temperature ≥37.8°C [ Time Frame: Up to 15 days after any vaccination ]
   The percentage of participants with maximum oral temperature ≥37.8°C was assessed.
7. Percentage of Participants With One or More Serious Adverse Events [ Time Frame: Up to Month 7 ]
   A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 15 Years (Child)
• Sexes 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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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® in 9-15-Year-Old Girls. Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT01304498
• Other Study ID Numbers: V503-009; GDS01C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number ); 2010-023393-39 ( EudraCT Number )
• First Posted: February 25, 2011
• Results First Posted: August 22, 2017
• Last Update Posted: December 14, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Vaccines; Immunologic Factors; Physiological Effects of Drugs