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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_052 |
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The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V501 | Experimental | V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6. |
|
| Placebo | Placebo Comparator | Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) | Biological | V501; Gardasil, 0.5 ml injection in 3 dosing regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0". | At one month after completed vaccination series (Month 7) |
| Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0". | At one month after completed vaccination series (Month 7) |
| Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0". | At one month after completed vaccination series (Month 7) |
| Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0". | At one month after completed vaccination series (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | Month 30 HPV cLIA Geometric Mean Titers by vaccine group. | 24 month after completed vaccination series (Month 30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32827835 | Derived | Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19. |
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Study was conducted at 8 sites in Japan from 2006 to 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | V501 | V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) |
| FG001 | Placebo | Placebo vaccination 0.5 ml injection in 3 dosing regimen. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V501 | V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) |
| BG001 | Placebo | Placebo vaccination 0.5 ml injection in 3 dosing regimen. |
| 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 | Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0". | The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers (mMU/mL) | At one month after completed vaccination series (Month 7) |
|
Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination.
All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
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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 | V501 | V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strabismus congenital | Congenital, familial and genetic disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
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| Comparator: Placebo (unspecified) | Biological | Placebo 0.5 ml injection in 3 dosing regimen |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | Kilogram |
|
| OG001 | Placebo | Placebo vaccination 0.5 ml injection in 3 dosing regimen. |
|
|
|
| Primary | Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0". | The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers (mMU/mL) | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Primary | Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0". | The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers (mMU/mL) | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Primary | Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0". | The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers (mMU/mL) | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Secondary | HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | Month 30 HPV cLIA Geometric Mean Titers by vaccine group. | The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers (mMU/mL) | 24 month after completed vaccination series (Month 30) |
|
|
|
|
| 2 |
| 82 |
| 77 |
| 82 |
| EG001 | Placebo | Placebo vaccination 0.5 ml injection in 3 dosing regimen. | 0 | 25 | 23 | 25 |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Malais | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-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.
| 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 |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D017778 | Vaccines, Combined |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| 198.2 |
| 2-Sided |
| 95 |
| 160.9 |
| 244.2 |
| Superiority or Other |
| Geometric Mean | 617.1 | 2-Sided | 95 | 491.7 | 774.5 | Superiority or Other |
| Geometric Mean | 90.0 | 2-Sided | 95 | 68.8 | 117.8 | Superiority or Other |