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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_532 |
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A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.
The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| qHPV | Experimental | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Placebo | Placebo Comparator | Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine | Biological | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block. | From Day 1 until >=25 cases accumulate, up to Month 30 |
| Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. | From Day 1 until >=17 cases accumulate, up to Month 30 |
| Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block. | Up to Month 78 |
| Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update) | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30122646 | Background | Wei L, Xie X, Liu J, Zhao Y, Chen W, Zhao C, Wang S, Liao X, Shou Q, Qiu Y, Qiao Y, Saah AJ. Efficacy of quadrivalent human papillomavirus vaccine against persistent infection and genital disease in Chinese women: A randomized, placebo-controlled trial with 78-month follow-up. Vaccine. 2019 Jun 12;37(27):3617-3624. doi: 10.1016/j.vaccine.2018.08.009. Epub 2018 Aug 16. | |
| 30638797 |
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Participants were stratified by age before randomization: 20 to 26 years of age and 27 to 45 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | qHPV | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 |
| FG001 | Placebo | Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study (Day 1 to Month 30) |
| |||||||||||||||||||
| Extension Study (Month 42 to Month 90) |
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | qHPV | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 |
| BG001 | Placebo | Placebo administered by intramuscular injection on 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 | Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block. | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Posted | Number | Cases per 100 person-years of follow-up | From Day 1 until >=25 cases accumulate, up to Month 30 | person-years | person-years |
|
Up to approximately 90 months
All vaccinated participants with safety follow-up
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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 | qHPV | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthyroidism | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | 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 |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Comparator: placebo (unspecified) | Biological | Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6. |
|
| Up to 15 days after any vaccination |
| Base Study: Percentage of Participants With One or More Systemic Adverse Events | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. | Up to 15 days after any vaccination |
| Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. | Up to 6 months |
| Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events | A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure. | Up to approximately 90 months |
| Entire Study: Percentage of Participants Who Died | The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm | Up to approximately 90 months |
| Up to 78 months |
| Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update) | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. | Up to 78 months |
| Derived |
| Chen W, Zhao Y, Xie X, Liu J, Li J, Zhao C, Wang S, Liao X, Shou Q, Zheng M, Saah AJ, Wei L, Qiao Y. Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up. Vaccine. 2019 Feb 4;37(6):889-897. doi: 10.1016/j.vaccine.2018.12.030. Epub 2019 Jan 9. |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| qHPV |
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 |
| OG001 | Placebo | Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 |
|
|
|
| Primary | Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. | The population analyzed included participants 20 to 26 years old at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Posted | Number | Cases per 100 person-years of follow-up | From Day 1 until >=17 cases accumulate, up to Month 30 | person-years | person-years |
|
|
|
|
| Primary | Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block. | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 16 and 18. | Posted | Number | Cases per 100 person-years of follow-up | Up to Month 78 | person-years | person-years |
|
|
|
|
| Primary | Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination. | All vaccinated participants with safety follow-up | Posted | Number | Percentage of participants | Up to 15 days after any vaccination |
|
|
|
| Primary | Base Study: Percentage of Participants With One or More Systemic Adverse Events | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. | All vaccinated participants with safety follow-up | Posted | Number | Percentage of participants | Up to 15 days after any vaccination |
|
|
|
| Primary | Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. | All vaccinated participants with safety follow-up | Posted | Number | Percentage of participants | Up to 6 months |
|
|
|
| Primary | Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events | A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure. | All vaccinated participants with safety follow-up | Posted | Number | Percentage of participants | Up to approximately 90 months |
|
|
|
| Primary | Entire Study: Percentage of Participants Who Died | The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm | All vaccinated participants with safety follow-up | Posted | Number | Percentage of participants | Up to approximately 90 months |
|
|
|
| Secondary | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update) | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Posted | Number | Cases per 100 person-years of follow-up | Up to 78 months | person-years | person-years |
|
|
|
|
| Secondary | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update) | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. | The population analyzed included participants 20 to 26 years of age at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Posted | Number | Cases per 100 person-years of follow-up | Up to 78 months | person-years | person-years |
|
|
|
|
| 38 |
| 1,499 |
| 876 |
| 1,499 |
| EG001 | Placebo | Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 | 43 | 1,498 | 799 | 1,498 |
| Thyroid Mass | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Benign Hydatidiform Mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Breast Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Fibroadenoma Of Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Intraductal Papilloma Of Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Ovarian Cancer Stage Iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Ovarian Germ Cell Teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Phyllodes Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Vaginal Cancer Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerebrovascular Disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Trigeminal Neuralgia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Abortion Missed | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Cephalo-Pelvic Disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Foetal Damage | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Foetal Death | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Gestational Hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Placenta Accreta | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Urethral Cyst | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cervical Polyp | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Endometrial Hyperplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fallopian Tube Cyst | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pelvic Fluid Collection | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Uterine Disorder | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Uterine Polyp | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epiglottic Cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Ectopic Pregnancy Termination | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Fallopian Tube Operation | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Haemorrhoid Operation | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Labour Induction | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Myomectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Synovial Cyst Removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Thyroid Adenoma Removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Thyroid Nodule Removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Uterine Polypectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| 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 |