Trial · NCT00779766
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
NCT00779766, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-05-10
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ConductScience Library. Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects. Trials, record NCT00779766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00779766
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
- NCT number
- NCT00779766
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,081 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Papillomavirus
- Interventions
- HPV GSK 580299 vaccine, Placebo control
- First posted
- 2008-10-24
- Last updated
- 2019-06-10
- Results first posted
- 2012-05-10
- Limitations and caveats
At the time of the event-triggered analysis at Month 24, some safety results remain blinded and are not presented here since the study is still ongoing. These results will be updated once they become available.
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | At Month 24 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Primary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | At Month 48 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Primary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | At Month 57 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Primary | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | At Month 72 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Secondary | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | At Months 24,48, 57 and 72 | HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Secondary | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Secondary | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Secondary | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Secondary | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Secondary | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | At Months 24,48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | At Month 24 | The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | At Month 48 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | At Month 57 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | At Month 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | At Months 24,48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | At Months 24,48, 57 and 72 | The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group2,382
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Cervarix Group | Sero negative, DNA negative HPV-16/18 | 1 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Placebo Group | Sero negative, DNA negative HPV-16/18 | 17 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Cervarix Group | Sero negative, DNA negative HPV-16 | 1 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Placebo Group | Sero negative, DNA negative HPV-16 | 15 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Cervarix Group | Sero negative, DNA negative HPV-18 | 0 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Placebo Group | Sero negative, DNA negative HPV-18 | 3 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Cervarix Group | DNA negative, HPV-16/18 | 1 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Placebo Group | DNA negative, HPV-16/18 | 27 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Cervarix Group | DNA negative, HPV-16 | 1 | Subjects | |
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Placebo Group | DNA negative, HPV-16 | 21 | Subjects |
1 to 10 of 2,382Source ClinicalTrials.gov
See all 2,382 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Month 24 | STARTED | Cervarix Group | 3,026 | |
| Month 24 | STARTED | Placebo Group | 3,025 | |
| Month 24 | COMPLETED | Cervarix Group | 2,694 | |
| Month 24 | COMPLETED | Placebo Group | 2,693 | |
| Month 24 | NOT COMPLETED | Cervarix Group | 332 | |
| Month 24 | NOT COMPLETED | Placebo Group | 332 | |
| Month 48 | STARTED | Cervarix Group | 2,703 | |
| Month 48 | STARTED | Placebo Group | 2,727 | |
| Month 48 | COMPLETED | Cervarix Group | 2,529 | |
| Month 48 | COMPLETED | Placebo Group | 2,559 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events204
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 |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Cervarix Group | 276 | 3,026 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Group | 290 | 3,025 | |
| other | Pain | General disorders | Cervarix Group | 2,634 | 3,005 | |
| other | Pain | General disorders | Placebo Group | 2,166 | 3,001 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Cervarix Group | 838 | 3,005 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Placebo Group | 517 | 3,001 | |
| other | Swelling | General disorders | Cervarix Group | 853 | 3,005 | |
| other | Swelling | General disorders | Placebo Group | 408 | 3,001 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cervarix Group | 270 | 3,005 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Group | 213 | 3,001 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cervarix Group | 0 | 3,026 |
| Total, all-cause mortality | Placebo Group | 3 | 3,025 |
| Total, other adverse events | Cervarix Group | 2,786 | 3,026 |
| Total, other adverse events | Placebo Group | 2,548 | 3,025 |
| Total, serious adverse events | Cervarix Group | 56 | 3,026 |
| Total, serious adverse events | Placebo Group | 81 | 3,025 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cervarix Group vs Placebo Group: Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Trial comparisons |
Cervarix Group vs Placebo Group: Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Trial comparisons |
| Cervarix Group vs Placebo Group: Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Trial comparisons |
Cervarix Group vs Placebo Group: Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Trial comparisons |
| Cervarix Group vs Placebo Group: Number of Subjects With Serious Adverse Events (SAEs) | Trial comparisons |
| Cervarix Group vs Placebo Group: Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Trial comparisons |
| Cervarix Group vs Placebo Group: Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity | Trial comparisons |
| Cervarix Group vs Placebo Group: deaths from any cause | Trial comparisons |
Cervarix Group vs Placebo Group: Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Trial comparisons |
| Cervarix Group vs Placebo Group: serious adverse events | 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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Read this trial from software.
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