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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a randomized, open label trial of HPV (human papilloma virus) vaccine, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either vaccine at 6 months or vaccine at 12 months.
Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that the GMTs in the test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.
The recommendations for HPV vaccine include catch-up of women 18 to 26 years old. Given that a large percentage of women in this age group are attending college, a good place to access them would be through the student health services on college campuses. However, the HPV vaccine schedule of 0, 2, and 6 months is likely to be difficult to implement in a college calendar year and the immunogenicity of alternative schedules is unknown. If the immunogenicity of an altered schedule is good, then higher vaccination rates may be achievable.
Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active Comparator | Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. |
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| 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine | Active Comparator | Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent human papillomavirus vaccine on-time administration | Biological | The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given six months after dose 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule | Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type. | 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K. Zimmerman, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20629576 | Result | Zimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753. |
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Two hundred young women from the university community who met the eligibility criteria were recruited at the Student Health Service.
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 Month Standard Schedule | Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. |
| FG001 | 12 Month Alternative Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Quadrivalent human papillomavirus vaccine delayed administration | Biological | The vaccine is given in three doses: Dose 1; dose 2 given 60 days later; dose 3 given 12 months after dose 1. |
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12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 Month Standard Schedule | Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. |
| BG001 | 12 Month Alternative Group | 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule | Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type. | The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive. | Posted | Geometric Mean | 95% Confidence Interval | milliMerck units per mL | 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule) |
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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 | 6 Month Standard Schedule | Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months. | 0 | 100 | 57 | 100 | ||
| EG001 | 12 Month Alternative Group | 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months | 0 | 100 | 55 | 100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soreness at the injection site | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment |
| |
| syncope | General disorders | Non-systematic Assessment | One case of brief syncope in 6 month arm resolved without consequence. |
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One participant in the Standard group did not respond to any of the vaccine HPV types. Eleven participants in the Alternate group either did not receive Dose 3 or were out of window, compared with only one participant in the Standard group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Zimmerman | University of Pittsburgh | 412-383-2354 | zimmer@pitt.edu |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Type 16 |
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| Type 18 |
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The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /[log (RGMC) -δ0] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm. |