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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_032 |
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A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | Biological | V501; Gardasil, 0.5 ml injection in 3 dosing regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype | Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up. | Over 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) 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) |
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 |
|---|---|---|---|
| 23331518 | Result | Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7. | |
| 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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There were no specific criteria.
Study was conducted at 14 sites in Japan from 2006 to 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | V501 | V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
| FG001 | Placebo | Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V501 | V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
| BG001 | Placebo | Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
| 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 | Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype | Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up. | Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type | Posted | Number | Incidence per 100 person-years | Over 30 months |
|
Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination.
The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine.
Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
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 | V501 | V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| 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 |
Not provided
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| Comparator: Placebo | Biological | Placebo 0.5 ml injection in 3 dosing regimen |
|
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) | Month 7 HPV 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) |
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) | Month 7 HPV 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) |
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) | Month 7 HPV 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) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Moved |
|
| Pregnancy |
|
| Laboratory test values abnormal |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
| OG001 | Placebo | Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 |
|
|
|
| Secondary | Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) 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". | Includes participants 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 had a Month 7 serum sample collected within an acceptable time range | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Secondary | Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) | Month 7 HPV 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". | Includes participants 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 had a Month 7 serum sample collected within an acceptable time range | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Secondary | Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) | Month 7 HPV 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". | Includes participants 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 had a Month 7 serum sample collected within an acceptable time range | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers | At one month after completed vaccination series (Month 7) |
|
|
|
|
| Secondary | Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) | Month 7 HPV 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". | Includes participants 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 had a Month 7 serum sample collected within an acceptable time range | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers | At one month after completed vaccination series (Month 7) |
|
|
|
|
| 39 |
| 480 |
| 435 |
| 480 |
| EG001 | Placebo | Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6 | 65 | 468 | 396 | 468 |
| Vertigo | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hernia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Ovarian abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Ovarian cystectomy | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site anaesthesia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | 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 induration | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site movement impairment | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Venipuncture site swelling | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Dental caries | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Laryngopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Lymph gland infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Injury corneal | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Genital pruritus female | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Oropharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sneezing | 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 |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Comedone | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Urticaria generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypotension | Vascular 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 |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |