Trial · NCT00316706
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
NCT00316706, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine. Trials, record NCT00316706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00316706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
- NCT number
- NCT00316706
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,245 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cervical Intraepithelial Neoplasia, Papillomavirus Infection
- Interventions
- GSK Biologicals' HPV-16/18 Vaccine (Cervarix™), Havrix™
- First posted
- 2006-04-21
- Last updated
- 2012-09-18
- Results first posted
- 2010-03-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | At 18, 24, 36 and 48 months | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). |
| Secondary | Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | At Months 18 and 24 | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| Secondary | Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up | At Month 36 and 48 | Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL. |
| Secondary | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up | From Month 18 to Month 24 | 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. |
| Secondary | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up | From Month 24 to Month 48 | Serious adverse events assessed include medical occurrences that result in death, is 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | At 18, 24, 36 and 48 months | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | At Months 18 and 24 | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up | At Month 36 and 48 | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up | From Month 18 to Month 24 | Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up | From Month 24 to Month 48 | Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-16 at Month 18 (n= 588) | 3901.6 | 95% Confidence Interval 3626.2 to 4198.0 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-16 at Month 24 (n= 549) | 3226.3 | 95% Confidence Interval 2988.4 to 3483.1 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-16 at Month 36 (n= 571) | 2688.6 | 95% Confidence Interval 2503.6 to 2887.3 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-16 at Month 48 (n= 559) | 2395.8 | 95% Confidence Interval 2230.5 to 2573.3 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-18 at Month 18 (n= 587) | 1570.8 | 95% Confidence Interval 1448.3 to 1703.7 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-18 at Month 24 (n= 548) | 1263.4 | 95% Confidence Interval 1165.1 to 1370.1 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-18 at Month 36 (n= 570) | 995.0 | 95% Confidence Interval 918.1 to 1078.4 | EL.U/mL |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Cervarix Group | Anti-HPV-18 at Month 48 (n= 559) | 885.6 | 95% Confidence Interval 816.3 to 960.8 | EL.U/mL |
| Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | Cervarix Group | Month 18 (n= 128, 129) | 347.2 | 95% Confidence Interval 297.8 to 404.7 | EL.U/mL |
| Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up | Havrix Group | Month 18 (n= 128, 129) | 117.7 | 95% Confidence Interval 101.3 to 136.8 | EL.U/mL |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cervarix Group | 626 | |
| Overall Study | STARTED | Havrix Group | 619 | |
| Overall Study | COMPLETED | Cervarix Group | 588 | |
| Overall Study | COMPLETED | Havrix Group | 571 | |
| Overall Study | NOT COMPLETED | Cervarix Group | 38 | |
| Overall Study | NOT COMPLETED | Havrix Group | 48 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abdominal pain | Gastrointestinal disorders | Cervarix Group | 3 | 626 | |
| serious | Abdominal pain | Gastrointestinal disorders | Havrix Group | 0 | 619 | |
| serious | Cellulitis | Infections and infestations | Cervarix Group | 1 | 626 | |
| serious | Cellulitis | Infections and infestations | Havrix Group | 0 | 619 | |
| serious | Constipation | Gastrointestinal disorders | Cervarix Group | 2 | 626 | |
| serious | Constipation | Gastrointestinal disorders | Havrix Group | 0 | 619 | |
| serious | Dermoid cyst of ovary | Congenital, familial and genetic disorders | Cervarix Group | 0 | 626 | |
| serious | Dermoid cyst of ovary | Congenital, familial and genetic disorders | Havrix Group | 1 | 619 | |
| serious | Loss of consciousness | Nervous system disorders | Cervarix Group | 0 | 626 | |
| serious | Loss of consciousness | Nervous system disorders | Havrix Group | 1 | 619 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cervarix Group | ||
| Total, all-cause mortality | Havrix Group | ||
| Total, other adverse events | Cervarix Group | 0 | 626 |
| Total, other adverse events | Havrix Group | 0 | 619 |
| Total, serious adverse events | Cervarix Group | 33 | 626 |
| Total, serious adverse events | Havrix Group | 5 | 619 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22265115 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cervarix Group vs Havrix Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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