Safety and Immunogenicity of Extended 2-dose Regimens of 9vHPV Vaccine
- Conditions
- MedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10071146Term: Human papilloma virus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]MedDRA version: 20.0Level: HLGTClassification code 10047438Term: Viral infectious disordersSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2020-003736-24-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. Is healthy individual who meets all inclusion criteria and none of the exclusion defined in this section.
2. Is male or female, from 10 years to 15 years of age inclusive, who received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive Dose 2 of any HPV vaccine (Cohort 0).
3. Is male or female, from 9 years to 14 years of age inclusive, on the day of enrollment (Cohorts 1 to 4).
4. Is female, from 16 years to 26 years inclusive, on the day of enrollment (Cohort 5).
5. (Participants 9 to 15 years of age only) Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period.
6. (Female participants 16 to 26 years of age only) Has never had Pap testing (cervical or anal) or has had only normal Pap test results.
7. (Female participants 16 to 26 years of age only) Has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. Male or female partner is defined as someone with whom the participant has had penile penetrative sexual intercourse or someone who has contacted, either by penetrative (with fingers or other objects) or nonpenetrative means, the participant's genitalia during sexual activity.
8. (Female participants 16 to 26 years of age only, defined as WOCBP) Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant’s last menstrual period through Day 1. The participant understands and agrees that during the intervention 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 per the protocol. Effective contraception is defined as a marketed, approved contraceptive product that the participant has used per the manufacturer’s instructions with every act of sexual intercourse.
9. Participant or participant’s legally acceptable representative understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by providing documented informed consent. As appropriate based on local guidelines, the participant will also provide documented informed assent for the study. The participant or the participant’s legally acceptable representative may also provide assent/consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
10. Agrees to provide study personnel with a primary telephone number as well as an alternate form of contact, if available, for follow-up purposes.
11. Participant or participant’s legally acceptable representative can read, understand, and complete the eVRC.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Has a fever (defined as oral temperature =100.0° F or =37.8° C) within the 24-hour period prior to the Day 1 visit.
2. Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
3. Is allergic to any vaccine component, including aluminum, yeast, or BENZONASETM (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for severe AEs or SAEs.
4. Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
5. Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other
autoimmune condition.
6. Has a history of splenectomy.
7. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has
had a recent history (within the last year) of drug or alcohol abuse or dependence at the
discretion of the investigator. Alcohol abusers are defined as those who drink despite
recurrent social, interpersonal, and/or legal problems because of alcohol use.
8. Has a history of a positive test for HPV.
9. (Female participants 16 to 26 years of age only) Has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia or worse).
10. (Female participants 16 to 26 years of age only) Has a history of HPV-related external genital lesions (eg, condyloma acuminata, or vulvar intraepithelial neoplasia) or external genital cancer, HPV-related vaginal lesions (eg, condyloma acuminata, or vaginal
intraepithelial neoplasia) or vaginal cancer, or HPV-related anal lesions (eg, condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
11. (Female participants only) Is pregnant as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG.
12. (Female participants only) Is expecting to donate eggs during the intervention period of the study.
13. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgment of investigator.
14. Has received within 12 months prior to enrollment, is receiving, or plans to receive during the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin,
leflunomide (AravaTM), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), IVIG, antilymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he/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 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.
15. Has received within the 3 months prior to th
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method