| ID | Type | Description | Link |
|---|---|---|---|
| 107477 | Other Identifier | GSK | |
| 107479 | Other Identifier | GSK | |
| 107481 | Other Identifier | GSK |
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The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix New Process | Experimental | Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV]) produced with the new manufacturing process. |
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| Cervarix Old Process Group | Experimental | Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV]) produced with the old manufacturing process. |
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| Cervarix Young/Lot 1 Group | Experimental | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV]) produced with the new manufacturing process (Lot 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarixâ„¢ | Biological | Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). *Data for Month 18 outcome variables were incorporated into the Month 24 analyses. | At months 18*, 24, 36 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | At months 24, 36, and 48 |
| Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples |
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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 | Tallinn | 1162 | Estonia |
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| Label | URL |
|---|---|
| Primary Study | View source |
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Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix New Process | Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
| FG001 | Cervarix Old Process Group | Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. |
| FG002 | Cervarix Young | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix New Process | Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
| BG001 | Cervarix Old Process Group |
| 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 |
| 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 | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). *Data for Month 18 outcome variables were incorporated into the Month 24 analyses. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At months 18*, 24, 36 and 48 |
|
During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.
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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 New Process | Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
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Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| At Months 24, 36 and 48 |
| Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases. | Throughout the study period (up to Month 48) |
| Number of Subjects Reporting SAEs | 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. | Throughout the study period (up to Month 48) |
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
| BG002 | Cervarix Young | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Cervarix Old Process Group |
Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. |
| OG002 | Cervarix Young | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. |
|
|
| Secondary | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At months 24, 36, and 48 |
|
|
|
| Secondary | Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. | Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 24, 36 and 48 |
|
|
|
| Secondary | Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases. | Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively. | Posted | Number | Subjects | Throughout the study period (up to Month 48) |
|
|
|
| Secondary | Number of Subjects Reporting SAEs | 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 of each time point. | Posted | Number | Subjects | Throughout the study period (up to Month 48) |
|
|
|
| 11 |
| 186 |
| 0 |
| 0 |
| EG001 | Cervarix Old Process Group | Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process. | 3 | 65 | 0 | 0 |
| EG002 | Cervarix Young | Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarixâ„¢ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process. | 3 | 57 | 0 | 0 |
| Anogenital warts | Infections and infestations | Non-systematic Assessment |
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| Enteritis infectious | Infections and infestations | Non-systematic Assessment |
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| Genital herpes | Infections and infestations | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blighted ovum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
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| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
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| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
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.
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| HPV-16 (Month 36) (n= 78, 27, 3) |
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| HPV-16 (Month 48) (n=69, 19, 4) |
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| HPV-18 (Month 24) (n= 55, 13, 1) |
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| HPV-18 (Month 36) (n= 78, 27, 3) |
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| HPV-18 (Month 48) (n= 66, 19, 4) |
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| Anti-HPV-16 [Month 36] (n=78;27;3) |
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| Anti-HPV-16 [Month 48] (n=69;19;4) |
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| Anti-HPV-18 [Month 24] (n=74;24;3) |
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| Anti-HPV-18 [Month 36] (n=78;27;3) |
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| Anti-HPV-18 [Month 48] (n=66;19;4) |
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| NOCDs from Month 36 to Month 48 (n= 169, 63, 51) |
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| MSCs from Month 12 to Month 24 (n= 186, 64, 57) |
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| MSCs from Month 24 to Month 36 (n= 184, 65, 53) |
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| MSCs from Month 36 to Month 48 (n= 169, 63, 51) |
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| Pregnancies from Month 12 to Month 24(n=186,64,57) |
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| Pregnancies from Month 24 to Month 36(n=184,65,53) |
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| Pregnancies from Month 36 to Month 48(n=169,63,51) |
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| From Month 36 to 48 (n=169,63,51) |
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