immunobridging study of 9- valent human papillomavirus (9vhpv) vaccine (v503) in chinese females 9 to 45 years of age (v503-024)

Conditions: Papillomavirus Infections

Summary: this study will investigate the immunogenicity and safety of the 9vhpv vaccine in healthy chinese females 9 to 45 years of age. the study consists of stage i (day 1 to month 7) and stage ii (post month 7 to month 60). stage ii will report the long-term immunogenicity and safety in the 9-19 year-old age group only. the dual-primary hypotheses of stage i are that 9vhpv vaccine induces non-inferior immune responses in females 9 to 19 years of age who are seronegative at day 1 to the relevant hpv type compared to females 20 to 26 years of age who are seronegative at day 1 to the relevant hpv type, as measured by anti-hpv 6, 11, 16, 18, 31, 33, 45, 52, and 58 gmts at 1 month post dose 3, and 9vhpv vaccine induces non-inferior immune responses in females 27 to 45 years of age who are seronegative at day 1 to the relevant hpv type compared to females 20 to 26 years of age who are seronegative at day 1 to the relevant hpv type, as measured by the seroconversion percentages to each of hpv types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 1 month post dose 3. (each vaccine component will be analyzed separately.)


Eligibility criteria:
inclusion criteria * participant is a chinese female judged to be in good physical health based on medical history and physical examination * not a woman of childbearing potential (wocbp) or if of wocbp, has not had sex with males or has had sex with males and used effective contraception as defined in appendix 2 since the first day of participant's last menstrual period through day 1. and the participant understands and agrees that during the day 1 through month 7 period, she should not have sexual intercourse with males without effective contraception, and that the use of the rhythm method, withdrawal, and emergency contraception are not acceptable methods * has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. male partner is defined as someone with whom the participant has penile penetrative sexual intercourse. female partner is defined as someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the participant's genitalia during sexual activity exclusion criteria * known allergy to any vaccine component, including aluminum, yeast, or benzonase™ (nuclease, nycomed™). an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event * history of severe allergic reaction (e.g. swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention * known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * has a fever (defined as an axillary temperature ≥37.1°c) within 24 hours prior to the day 1 vaccination * has any history of abnormal pap test showing squamous intraepithelial lesion (sil) or atypical squamous cells - undetermined significance (asc-us), atypical squamous cells - cannot exclude hsil (asc-h), atypical glandular cells, or biopsy showing cervical intraepithelial neoplasia (cin), adenocarcinoma in situ or cervical cancer * history of external genital wart, vulvar intraepithelial neoplasia (vin), vaginal intraepithelial neoplasia (vain), vulvar cancer or vaginal cancer * history of a positive test for hpv * currently immunocompromised or has been 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 * donated blood within 1 week prior to the day 1 vaccination, or intends to donate during day 1 through month 7 of the study * expecting to donate eggs during day 1 through month 7 of the study * pregnant * receiving or has received in the year prior to day 1 vaccination the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (arava™), tumor necrosis factor (tnf)-α antagonists, monoclonal antibody therapies (including rituximab \[rituxan™\]), intravenous gamma globulin (ivig), antilymphocyte sera, or other therapy known to interfere with the immune response. with regard to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of day 1 vaccination) 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 corticosteroids are considered eligible for the study * has received immune globulin product (including rhogam™ or blood-derived product other than ivig within 6 months prior to day 1 vaccination, or plans to receive any such product during day 1 through month 7 of the study * has received a marketed hpv vaccine, or has participated in an hpv vaccine clinical trial and has received either active agent or placebo * has received inactivated or recombinant vaccines within 14 days prior to day 1 vaccination or has received live vaccines within 21 days prior to day 1 vaccination * concurrently enrolled in clinical studies of interventional agents * a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use