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This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Women 27- to 45-years Old | Experimental | Adult women 27- to 45-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. |
|
| Young Adult Women 16- to 26-years Old | Active Comparator | Young adult women 16- to 26-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V503 | Biological | V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type | Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58). | 4 weeks post vaccination 3 (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Experienced at Least 1 Adverse Event (AE) | An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002) | Graz | Austria | ||||
| Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33676783 | Derived | Joura EA, Ulied A, Vandermeulen C, Rua Figueroa M, Seppa I, Hernandez Aguado JJ, Ahonen A, Reich O, Virta M, Perino A, Peris Tuser M, Peters K, Origoni M, Raspagliesi F, Tjalma WAA, Tummers P, Woelber L, Nieminen P, van Damme P, Sehouli J, Fiol Ruiz G, Brucker S, Fehm T, Cheon K, Rawat S, Luxembourg A, Wittke F. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. Vaccine. 2021 May 12;39(20):2800-2809. doi: 10.1016/j.vaccine.2021.01.074. Epub 2021 Mar 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Women 16-26 Years of Age | Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. |
| FG001 | Women 27-45 Years of Age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 15, 2017 |
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|
| Up to 1 month post vaccination 3 (up to 7 months) |
| Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event. | An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed. | Up to 1 month post vaccination 3 (up to 7 months) |
| Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event | Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed. | Up to 5 days post any vaccination |
| Percentage of Participants That Reported at Least 1 Systemic Adverse Event | An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed | Up to 15 days post any vaccination |
| Percentage of Participants With Elevated Temperature (Fever) | Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed. | Up to 5 days post any vaccination |
| Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types | Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed. | 4 weeks post vaccination 3 (Month 7) |
| Vienna |
| Austria |
| Universitair Ziekenhuis Antwerpen ( Site 0007) | Edegem | Belgium |
| Universitair Ziekenhuis Gent ( Site 0006) | Ghent | Belgium |
| Universitair Ziekenhuis Gasthuisberg ( Site 0005) | Leuven | Belgium |
| University of Antwerp ( Site 0004) | Wilrijk | Belgium |
| HUS Katiloopiston sairaala ( Site 0009) | Helsinki | Finland |
| Ita-Helsingin Rokotetutkimuskeskus ( Site 0011) | Helsinki | Finland |
| Porin Rokotetutkimusklinikka ( Site 0012) | Pori | Finland |
| Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010) | Tampere | Finland |
| Turun rokotetutkimusklinikka ( Site 0037) | Turku | Finland |
| Universitaetsmedizin Berlin Charite ( Site 0016) | Berlin | Germany |
| Universitaetsklinikum Duesseldorf ( Site 0014) | Düsseldorf | Germany |
| Praxis Dr. Peters ( Site 0015) | Hamburg | Germany |
| Universitaetsklinikum Hamburg-Eppendorf ( Site 0017) | Hamburg | Germany |
| Universitaetsklinikum Tuebingen ( Site 0013) | Tübingen | Germany |
| Istituto Nazionale dei tumori ( Site 0020) | Milan | Milan | Italy |
| Ospedale San Raffaele ( Site 0022) | Milan | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023) | Palermo | Italy |
| CAP Centelles ( Site 0027) | Centelles | Barcelona | Spain |
| Complejo Hospitalario de Torrecardenas ( Site 0030) | AlmerÃa | Spain |
| Institut Catala Oncologia de Bellvitge - ICO ( Site 0026) | L'Hospitalet de Llobregat | Spain |
| Hospital Sanitas La Moraleja ( Site 0031) | Madrid | Spain |
| Hospital Universitario Infanta Leonor ( Site 0028) | Madrid | Spain |
Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
| Vaccination 1 |
|
| Vaccination 2 |
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| Vaccination 3 |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Women 16-26 Years of Age | Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. |
| BG001 | Women 27-45 Years of Age | Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race | Count of Participants | Participants |
|
| 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 | Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type | Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58). | Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | 4 weeks post vaccination 3 (Month 7) |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced at Least 1 Adverse Event (AE) | An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed. | All participants that received at least 1 vaccination and had available data for endpoint. | Posted | Number | Percentage of Participants | Up to 1 month post vaccination 3 (up to 7 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event. | An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed. | All participants that received at least 1 vaccination and had available data for endpoint. | Posted | Number | Percentage of Participants | Up to 1 month post vaccination 3 (up to 7 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event | Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed. | All participants that received at least 1 vaccination and had available data for endpoint. | Posted | Number | Percentage of Participants | Up to 5 days post any vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Reported at Least 1 Systemic Adverse Event | An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed | All participants that received at least 1 vaccination and had available data for endpoint. | Posted | Number | Percentage of Participants | Up to 15 days post any vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Elevated Temperature (Fever) | Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed. | All participants that received at least 1 vaccination and had available data for endpoint. | Posted | Number | Percentage of Participants | Up to 5 days post any vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types | Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed. | Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 4 weeks post vaccination 3 (Month 7) |
|
|
Up to 1 month post vaccination 3 (up to 7 months)
Population included all participants that received at least 1 vaccination.
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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 | Women 16-26 Years of Age | Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. | 0 | 570 | 6 | 570 | 518 | 570 |
| EG001 | Women 27-45 Years of Age | Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. | 0 | 640 | 8 | 640 | 574 | 640 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Basilar migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 4, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Not Hispanic |
|
| Unknown |
|
| Asian |
|
| Black or African American |
|
| Multiple |
|
| White |
|
| Anti-HPV 11 |
|
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| Anti-HPV 16 |
|
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| Anti-HPV 18 |
|
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| Anti-HPV 31 |
|
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| Anti-HPV 33 |
|
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| Anti-HPV 45 |
|
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| Anti-HPV 52 |
|
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| Anti-HPV 58 |
|
|
| Anti HPV 18 | ANOVA | < 0.001 | Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.71 | 2-Sided | 95 | 0.64 | 0.80 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Anti HPV 31 | ANOVA | < 0.001 | ANOVA model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.66 | 2-Sided | 95 | 0.60 | 0.74 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Anti HPV 33 | ANOVA | < 0.001 | ANOVA model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.73 | 2-Sided | 95 | 0.67 | 0.80 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Anti HPV 45 | ANOVA | < 0.001 | ANOVA model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.68 | 2-Sided | 95 | 0.60 | 0.76 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Anti HPV 52 | ANOVA | < 0.001 | ANOVA model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.71 | 2-Sided | 95 | 0.64 | 0.78 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Anti HPV 58 | ANOVA | < 0.001 | ANOVA model with response of log individual titers and a fixed effect for age groups. | Fold Difference | 0.69 | 2-Sided | 95 | 0.63 | 0.76 | Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds | Non-Inferiority | Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5. |
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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