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

Human Papillomavirus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304498
• Other study ID #: V503-009
• Secondary ID: GDS01C2010-02339
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2011
• Est. completion date: December 20, 2011

Study information

• Verified date: November 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 20, 2011
• Est. primary completion date: December 20, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Biological:
• V503
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 Va — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GMTs to HPV Types 6 and 11	Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.	4 weeks postdose 3 (Month 7)
Secondary	Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18	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.	4 weeks postdose 3 (Month 7)
Secondary	Percentage of Participants With One or More Adverse Events	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.	Up to Month 7
Secondary	Percentage of Participants With One or More Injection-site Adverse Reactions	The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.	Up to 5 days after any vaccination
Secondary	Percentage of Participants With One or More Systemic Adverse Events	The percentage of participants with one or more systemic adverse events was assessed.	Up to 15 days after any vaccination
Secondary	Percentage of Participants With Maximum Oral Temperature =37.8°C	The percentage of participants with maximum oral temperature =37.8°C was assessed.	Up to 15 days after any vaccination
Secondary	Percentage of Participants With One or More Serious Adverse Events	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.	Up to Month 7