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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007876-41 | EudraCT Number |
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Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix™ & Engerix™ Group | Experimental | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). |
|
| Engerix™ Group | Active Comparator | Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) | Biological | Intramuscular administration, 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix | A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL). | Month 3 |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix | Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL). | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies | Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21734063 | Background | Leroux-Roels G, Haelterman E, Maes C, Levy J, De Boever F, Licini L, David MP, Dobbelaere K, Descamps D. Randomized trial of the immunogenicity and safety of the Hepatitis B vaccine given in an accelerated schedule coadministered with the human papillomavirus type 16/18 AS04-adjuvanted cervical cancer vaccine. Clin Vaccine Immunol. 2011 Sep;18(9):1510-8. doi: 10.1128/CVI.00539-10. Epub 2011 Jul 6. | |
| 41276263 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111567 | Informed Consent Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix™ & Engerix™ Group | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). |
| FG001 | Engerix™ Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Engerix™ | Biological | Intramuscular administration, 4 doses. |
|
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| Months 2 and 7 |
| Anti-HPV-16/18 Antibody Titers | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | Months 2 and 7 |
| Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies | Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination. | Months 2, 3 and 13 |
| Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course | A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL. | Months 2 and 13 |
| Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course | Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL. | At Months 2 and 13 |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses. | During the 7-day period following any vaccination |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses. | During the 7-day period following the 4th dose of HBV vaccine |
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria. Data are presented across doses. | During the 7-day period following any vaccination |
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria. Data are presented across doses. | During the 7-day period following the 4th dose of HBV vaccine |
| Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | During the 30-day period following any vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | During the 30-day period following the 4th dose of HBV vaccine |
| Number of Subjects Reporting Serious Adverse Events (SAE) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Up to study end (Month 13) |
| Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | Up to study end (Month 13) |
| La Louvière |
| 7100 |
| Belgium |
| Derived |
| Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111567 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix™ & Engerix™ Group | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). |
| BG001 | Engerix™ Group | Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 Seroprotected Against Hepatitis B Following 3 Doses of Engerix | A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination . | Posted | Count of Participants | Participants | Month 3 |
|
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| |||||||||||||||||||||||||||||
| Primary | Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix | Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL). | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Month 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies | Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data. | Posted | Count of Participants | Participants | Months 2 and 7 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Anti-HPV-16/18 Antibody Titers | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). | Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Months 2 and 7 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies | Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination. | Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination. | Posted | Count of Participants | Participants | Months 2, 3 and 13 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course | A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination. | Posted | Count of Participants | Participants | Months 2 and 13 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course | Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 2 and 13 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period following any vaccination |
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| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period following the 4th dose of HBV vaccine |
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| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria. Data are presented across doses. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period following any vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria. Data are presented across doses. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 7-day period following the 4th dose of HBV vaccine |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 30-day period following any vaccination |
|
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 30-day period following the 4th dose of HBV vaccine |
|
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Up to study end (Month 13) |
|
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| Secondary | Number of Subjects Reporting Medically Significant Conditions | Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. | Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Up to study end (Month 13) |
|
|
From Month 0 up to Month 13.
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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 | Cervarix™ & Engerix™ Group | Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). | 2 | 76 | 76 | 76 | ||
| EG001 | Engerix™ Group | Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12). | 2 | 76 | 73 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Non-systematic Assessment |
| |
| Graves-Basedow's disease | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at injection site | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Redness at injection site | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Swelling at injection site | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal symptom | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Myalgia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Temperature | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pharyngitis | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D006509 | Hepatitis B |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
| D000086982 | Blood-Borne Infections |
| D018347 | Hepadnaviridae Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| C075654 | Engerix-B |
Not provided
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| Male |
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