Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ
Conditions
Interventions
Trade Name: Gardasil®
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Human papillomavirus type 11 L1 protein
Current Sponsor code: V501
Other descriptive name
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Not pregnant and 1) not a woman of childbearing potential (WOCBP), or 2) a WOCBP who has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1 and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (the rhythm method, withdrawal, and emergency contraception are not acceptable methods per the protocol). Participant and participant's parent or guardian (participants aged 9-17 years only) provided written informed consent/assent. Provided a primary and alternative telephone for follow-up purposes. Extension Stage: participant was enrolled in the 9-19 years old group, received 3 doses of V501 in the Base Stage, and participant and participant's legally acceptable representative (if applicable) provided written informed consent/assent for the study extension. Are the trial subjects under 18? yes Number of subjects for this age range: 190 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 476 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of severe allergic reaction that required medical intervention. Allergic to any vaccine component, including aluminum, yeast, or Benzonase® (nuclease). Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. Currently immunocompromised or was diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition. History of splenectomy. Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives. History of recent or ongoing alcohol or other drug abuse. History of a positive test for HPV. Any history of abnormal Pap test. History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer. Undergone hysterectomy (either vaginal or total abdominal hysterectomy). Receiving or has received in the year prior to Day 1 vaccination an excluded immunosuppressive therapy. A participant will be excluded if she is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal or topical steroids are considered eligible for the study. Received immune globulin product or blood-derived product within 6 months prior to Day 1 vaccination, or plans to receive any such product during the study. Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. Received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 21 days prior to Day 1 vaccination. Concurrently enrolled in a clinical study of investigational agents. Had >4 lifetime sexual partners. Unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled. An immediate family member who is investigational site or sponsor staff directly involved with this study. Extension Stage: reported overdose or received non-study HPV vaccine during the Base Stage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA): Base Stage - Antibody Titers as Measured by cLIA: Extension Stage - Seropositivity Rates as Measured by cLIA: Extension Stage: - Antibody Titers as Measured by Immunoglobulin G Luminex Immunoassay: Extension Stage: - Seropositivity Rates as Measured by IgG LIA: Extension Stage:;Secondary Objective: - Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA: Base Stage - Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA: Base Stage - Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA: Base Stage - Percentage of Participants With a Solicited Injection-site Adverse Event (AE): Base Stage - Percentage of Participants With a Solicited Systemic AE: Base Stage - Percentage of Participants Who Have a Serious Adverse Event (SAE): Base Stage - Percentage of Participants With Any AE: Base Stage - Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria: Base Stage - Serious Adverse Events: Extension Stage: ;Primary end point(s): - Antibodies to HPV Types 6, 11, 16, and 18 were measured using a cLIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). - Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using a Competitive Luminex Immunoassay (cLIA). This Outcome Measure applies only to participants aged 9 to 19 years. - The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using cLIA. This Outcome Measure applies only to participants aged 9 to 19 years. - Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using an Immunoglobulin G Luminex Immunoassay (IgG LIA). This Outcome Measure applies only to participants aged 9 to 19 years. - The perce | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using cLIA. - Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). - The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA. - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus. - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough. - An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment In the global studies, fever is defined as an oral temperature of =37.8°C or 100.0°F, which is equivalent to axillary temperature of =37.2°C, while the definition of fever is axillary temperature of =37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of = | — |
Countries
China
Contacts
Public ContactMing Huan Zheng
Merck Sharp & Dohme LLC
Outcome results
None listed