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| ID | Type | Description | Link |
|---|---|---|---|
| RP190022 | Other Grant/Funding Number | Cancer Prevention & Research Institute of Texas |
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| Name | Class |
|---|---|
| Cancer Prevention Research Institute of Texas | OTHER |
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The investigators are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.
The investigators are studying an amended dosing regimen of an approved drug (Gardasil 9) in the population for which it is approved (vaccine is approved for ages 9-45 years and participants in this study will be 15-26 years of age.) The purpose of the study is to examine a delayed dosing schedule. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-26 years of age but only 2 doses (0 and 6 months) if given at 9-14 years of age. The investigators will conduct a randomized study to determine if 2 doses will elicit an immune response similar to the standard 3 doses in those 15-26 years of age. Participants in the study group will receive 2 doses of Gardasil 9 at 0 and 6 months. Participants in the control group will receive 3 doses of Gardasil 9 at 0, 1-2 months and 6 months. All participants (Target Accrual n=512) will have 5 mLs of blood drawn at 0, 7, and 12 months. Following the 12 month blood draw, participants randomized to 2-doses will receive the 3rd dose. Potential participants will be recruited in the University of Texas Medical Branch (UTMB) clinics where providers have given the PI permission to directly contact patients. The investigators will also display signs and use email announcements at UTMB and other college campuses and will advertise the study online or by mail. The investigators will call UTMB patients if their provider gave permission to contact the patient, or if the patients gave prior consent to contact through the UTMB system. Potential participants (and their parents, if under 18 years of age) will be screened with inclusion/exclusion criteria. Eligible and interested parents and patients will sign informed written consent. Patients under 18 years of age will sign written assent. At the initial visit, eligible, consented participants will have their blood drawn, be randomized into either the study or control group, and receive a dose of the HPV vaccine. Participants will be re-screened against the inclusion/exclusion criteria at subsequent visits. All participants will receive compensation administered through a ClinCard following each of the 3 blood draws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Females, 3 dose standard | Active Comparator | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. |
|
| Females, 2 dose with delayed 3rd dose | Experimental | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. |
|
| Males, 3 dose standard | Active Comparator | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. |
|
| Males, 2 dose with delayed 3rd dose | Experimental | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-valent HPV vaccine, 2 dose efficacy | Biological | Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-11 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as measured as % of participants who seroconvert. | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-16 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-18 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-31 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-33 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbey B Berenson, MD, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. | |
| 38320488 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Females, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
| FG001 | Females, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| FG002 | Males, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
| FG003 | Males, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Females, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
| BG001 | Females, 2 Dose With Delayed 3rd Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
Adverse event data were collected beginning with the initial inoculation through 6 weeks after administration of the final dose (30 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Females, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbey Berenson | University of Texas Medical Branch | 409-772-2417 | abberens@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2025 | Jan 28, 2026 | Prot_SAP_000.pdf |
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Vials submitted for assay will be de-identified and labeled only with the study ID number.
| 9-valent HPV vaccine, 3 doses standard timing | Biological | Will be comparison group for 2 dose efficacy group. |
|
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert |
| Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-45 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-52 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert | Month 7 |
| Short-term HPV Type-specific Antibody Response for Type HPV-58 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert | Month 7 |
| HPV Type-specific Antibody Response for Type HPV-6 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-11 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-16 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-18 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-31 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-33 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-45 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-52 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert | Month 12 |
| HPV Type-specific Antibody Response for Type HPV-58 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert | Month 12 |
| Derived |
| Berenson AB, Panicker G, Unger ER, Rupp RE, Kuo YF. Immunogenicity of 2 or 3 Doses of 9vHPV Vaccine in U.S. Female Individuals 15 to 26 Years of Age. NEJM Evid. 2024 Feb;3(2):EVIDoa2300194. doi: 10.1056/EVIDoa2300194. Epub 2024 Jan 23. |
| Lost to Follow-up |
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| Pregnancy |
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| Protocol Violation |
|
| Moved |
|
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| BG002 | Males, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
| BG003 | Males, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Seropositivity at Baseline | Participants may be positive for more than one serotype | Per-Protocol Population | Count of Participants | Participants |
|
| OG001 | Females, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
| OG002 | Males, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. |
| OG003 | Males, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. |
|
|
| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-11 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as measured as % of participants who seroconvert. | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
|
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-16 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-18 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
|
|
| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-31 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-33 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-45 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-52 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
|
|
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| Primary | Short-term HPV Type-specific Antibody Response for Type HPV-58 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 7 |
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| Primary | HPV Type-specific Antibody Response for Type HPV-6 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
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| Primary | HPV Type-specific Antibody Response for Type HPV-11 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
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| Primary | HPV Type-specific Antibody Response for Type HPV-16 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-18 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-31 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-33 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-45 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-52 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
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| Primary | HPV Type-specific Antibody Response for Type HPV-58 | Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert | The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed. | Posted | Number | 95% Confidence Interval | % of participants with seroconversion | Month 12 |
|
|
|
| 0 |
| 221 |
| 0 |
| 221 |
| 0 |
| 221 |
| EG001 | Females, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. | 0 | 217 | 0 | 217 | 0 | 217 |
| EG002 | Males, 3 Dose Standard | Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months. 9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group. | 0 | 165 | 0 | 165 | 0 | 165 |
| EG003 | Males, 2 Dose With Delayed 3rd Dose | Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. 9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females. | 0 | 164 | 0 | 164 | 0 | 164 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
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|
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