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This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.
This protocol posting deals with objectives & outcome measures of the extension phase at Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. |
|
| Aimmugen Group | Placebo Comparator | subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid-based cytology (LBC) sampling | Procedure | LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen. | Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | From Month 0 up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18. | Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. |
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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 | Aomori | 036-8003 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31824976 | Derived | Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec. | |
| 25424783 |
| 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 |
|---|---|---|---|
| 112949 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Subjects were randomised in the primary vaccination study NCT00316693 to receive the Cervarix vaccine or the Aimmugen vaccine and were aged 20 - 25 years at the time of first vaccination. Only subjects showing willingness to participate in this long term follow-up study and who had signed the informed consent form entered this study.
No vaccines were administered in this extension study. The mean duration of this study was aproximately 12 months for each subjects (from Month 0 up to Month 12). This study began 36 months after the first vaccination in study NCT00316693.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. |
| FG001 | Aimmugen Group | subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Blood sampling | Procedure | Blood samples will be collected at Months 36 and 48 for antibody determination |
|
| From Month 0 up to Month 12 |
| Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types. | Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC. HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | From Month 0 up to Month 12 |
| Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen. | Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | From Month 0 up to Month 12 |
| Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18. | For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | From Month 0 up to Month 12 |
| Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types. | HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | From Month 0 up to Month 12 |
| Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18. | Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | From Month 0 up to Month 12 |
| Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types. | Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | From Month 0 up to Month 12 |
| Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values. | Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group. | At Month 0 and at Month 12 |
| HPV-16 and HPV-18 Antibody Titers | Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group. | At Month 0 and at Month 12 |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity. | NOCDs included autoimmune diseases, diabetes mellitus. | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
| Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity. | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
| Number of Subjects With Medically Significant Conditions (MSCs). | MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease. | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
| Number of Subjects With Pregnancies and Pregnancy Outcomes. | Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA). | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693). |
| Fukui |
| 910-0858 |
| Japan |
| GSK Investigational Site | Hiroshima | 733-0813 | Japan |
| GSK Investigational Site | Hiroshima | 734-0036 | Japan |
| GSK Investigational Site | Kagoshima | 890-0055 | Japan |
| GSK Investigational Site | Kagoshima | 892-0824 | Japan |
| GSK Investigational Site | Miyazaki | 889-1692 | Japan |
| GSK Investigational Site | Osaka | 530-0013 | Japan |
| GSK Investigational Site | Tokyo | 102-0083 | Japan |
| GSK Investigational Site | Tokyo | 160-0017 | Japan |
| GSK Investigational Site | Tokyo | 173-0005 | Japan |
| GSK Investigational Site | Tokyo | 183-0056 | Japan |
| GSK Investigational Site | Tokyo | 189-0014 | Japan |
| Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112949 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112949 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112949 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112949 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112949 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. |
| BG001 | Aimmugen Group | subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Japanase women aged 20 to 25 years at the time of first vaccination in the primary study NCT00316693 | 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 Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen. | Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC). Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR). For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18. | Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types. | Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC. HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen. | Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18. | For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types. | HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18. | Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days). For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type. For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type. | The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types. | Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between. HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. | The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study. | Posted | Number | Subjects | From Month 0 up to Month 12 |
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| Secondary | Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values. | Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component. | Posted | Number | Subjects | At Month 0 and at Month 12 |
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| Secondary | HPV-16 and HPV-18 Antibody Titers | Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group. | The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 0 and at Month 12 |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. | The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. | Posted | Number | Subjects | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
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| Secondary | Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity. | NOCDs included autoimmune diseases, diabetes mellitus. | The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. | Posted | Number | Subjects | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
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| Secondary | Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity. | The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. | Posted | Number | Subjects | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
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| Secondary | Number of Subjects With Medically Significant Conditions (MSCs). | MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease. | The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. | Posted | Number | Subjects | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 |
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| Secondary | Number of Subjects With Pregnancies and Pregnancy Outcomes. | Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA). | The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. | Posted | Number | Subjects | During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693). |
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SAEs: from Month 24 (last study visit in the primary vaccination study NCT00316693) until Month 12 in this current follow-up study.
The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available. Other adverse events (solicited and unsolicited) were not assessed and not reported during this study.
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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 Group | subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693. | 11 | 375 | 0 | 0 | ||
| EG001 | Aimmugen Group | subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693. | 16 | 377 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Allergic granulomatous angiitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Borderline personality disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | Non-systematic Assessment |
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| Mastitis | Infections and infestations | Non-systematic Assessment |
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| Multiple sclerosis | Nervous system disorders | Non-systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | Non-systematic Assessment |
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| Pneumonia mycoplasmal | Infections and infestations | Non-systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Still's disease adult onset | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Threatened labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Ventricular septal defect | Congenital, familial and genetic disorders | 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 |
| D002578 | Uterine Cervical Dysplasia |
| 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 |
| D011230 | Precancerous Conditions |
| 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
Not provided
| ID | Term |
|---|---|
| C085467 | AKAP13 protein, human |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
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| CIN1+ HPV-18 (N=294;291) |
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