Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004_083 |
Not provided
Not provided
Not provided
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The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 100% Formulation qHPV Vaccine |
|
| 2 | Experimental | 60% Formulation qHPV Vaccine |
|
| 3 | Experimental | 40% Formulation qHPV Vaccine |
|
| 4 | Experimental | 20% Formulation qHPV Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine | Biological | qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL). | Week 4 Postdose 3 (Month 7) |
| Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | |
| Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL). | Week 4 Postdose 3 (Month 7) |
| Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | |
| Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive. | Week 4 Postdose 3 (Month 7) |
| Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) | |
| Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). | Week 4 Postdose 3 (Month 7) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17079588 | Background | Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461. | |
| 18313445 |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 20% Formulation qHPV Vaccine | Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. |
| FG001 | 40% Formulation qHPV Vaccine | Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6. |
| FG002 | 60% Formulation qHPV Vaccine | Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6 |
| FG003 | 100% Formulation qHPV Vaccine | Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6. |
| FG004 | Extension Study | Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as "Completed Period" are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study Vaccination Period |
|
| ||||||||||||||||||||||||
| Base Study Follow-up Period |
| |||||||||||||||||||||||||
| Extension Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20% Formulation qHPV Vaccine | Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. |
| BG001 | 40% Formulation qHPV Vaccine |
| 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 | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
Not provided
Adverse events were collected from subjects with follow-up.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20% Formulation | Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
Of note, the number of subjects who completed the Vaccination Period (N=1441) is slightly higher than that specified in the publication by Block, et al (2006; N=1430). The data provided here is based on final data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| D014614 | Vaccines, Synthetic |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL). | Week 4 Postdose 3 (Month 7) |
| Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | Week 4 Postdose 3 (Month 7) |
| Background |
| Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001. |
| 18000825 | Background | Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260. |
| 17955433 | Background | Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17. |
| 19935017 | Derived | Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21. |
| 19453788 | Derived | Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23. |
| Extended |
|
| *Clinical AE |
|
| *Other reasons |
|
| *Pregnancy |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Moved |
|
| Other |
|
| Pregnancy |
|
| Parent Withdrew Consent |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
| BG002 | 60% Formulation qHPV Vaccine | Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6 |
| BG003 | 100% Formulation qHPV Vaccine | Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | : Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 | : Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive. | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Number | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 | Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL). | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Number | Subjects | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| Primary | Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Week 4 Postdose 3 (Month 7) |
|
|
|
|
| 5 |
| 496 |
| 434 |
| 496 |
| EG001 | 40% Formulation | Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. | 2 | 509 | 426 | 509 |
| EG002 | 60% Formulation | Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. | 1 | 500 | 431 | 500 |
| EG003 | 100% Formulation | Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. | 4 | 1,498 | 1,276 | 1,498 |
| Tachycardia foetal | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Failed trial of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia nervosa | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
| D030361 | Papillomavirus Infections |
| 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 |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (boys/women) must be greater than 0.5. |
| HPV 6 < 20 mMU/mL |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| Miettinen and Nurminen | Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| ANOVA |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
| ANOVA | ANOVA on natural log titer with fixed effects for region and comparison group. | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (boys - women) must be greater than -5%. |
ANOVA on natural log titer with fixed effects for region and comparison group |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (boys/women) must be greater than 0.5. |
| HPV 11 < 16 mMU/mL |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| Miettinen and Nurminen | Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| ANOVA |
ANOVA on natural log titer with fixed effects for region and comparison group |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
| ANOVA | ANOVA on natural log titer with fixed effects for region and comparison group. | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (boys - women) must be greater than -5%. |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (boys/women) must be greater than 0.5. |
| HPV 16 < 20 mMU/mL |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| Miettinen and Nurminen | Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| ANOVA |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
| ANOVA | ANOVA on natural log titer with fixed effects for region and comparison group. | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (boys - women) must be greater than -5%. |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (boys/women) must be greater than 0.5. |
| HPV 18 < 24 mMU/mL |
|
| Miettinen and Nurminen |
Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| Miettinen and Nurminen | Miettinen and Nurminen method for difference in proportions Miettinen and Nurminen, Stat Med 1985;4:213-26 | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The difference in seroconversion rates (partial dose - full dose) must be greater than -5%. |
| ANOVA |
ANOVA on natural log titer with fixed effects for region and comparison group. |
| <0.001 |
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |
| ANOVA | ANOVA on natural log titer with fixed effects for region and comparison group. | <0.001 | 95 | Yes | Non-Inferiority or Equivalence | The ratio of GMTs (partial dose/full dose) must be greater than 0.5. |