Trial · NCT03629886
Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
NCT03629886, Phase 4, Completed, GlaxoSmithKline; results first posted 2020-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study. Trials, record NCT03629886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03629886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
- NCT number
- NCT03629886
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6,051 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- HPV (Types 16, 18) Vaccine, Adsorbed
- First posted
- 2018-08-14
- Last updated
- 2024-03-15
- Results first posted
- 2020-12-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group | During the entire study period (Day 1-Month 12) | SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as related to vaccination in the study. |
| Secondary | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group | During the entire study period (Day 1-Month 12) | pIMDS are a subset of adverse events (AEs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. |
| Secondary | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Outcomes of the reported pregnancies were: Live infant no apparent Congenital Anomaly (CA), Live infant CA, Elective termination no apparent CA, Elective termination CA, Spontaneous abortion no apparent CA, Spontaneous abortion CA, Stillbirth no apparent CA, Stillbirth CA, Ectopic pregnancy, Molar pregnancy, Lost to follow-up \& Pregnancy ongoing. |
| Secondary | Number of Subjects With SAEs in Vacc-092 Group | During the entire study period (Day 1-Month 12) | SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
| Secondary | Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group | During the entire study period (Day 1-Month 12) | AEs assessed include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as the occurrence of any unsolicited AE/SAE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects With SAEs Related to Study Participation in All Study Groups | During the entire study period (Day 1-Month 12) | SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as activities related to study participation and not by study vaccine (e.g. SAEs due to invasive tests). |
| Secondary | Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative and Seronegative Subjects at Baseline in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 and seronegative at Month 0 for the corresponding HPV type in study HPV 039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 and seronegative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV 039 (NCT00779766). |
| Secondary | Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 for the corresponding HPV type in study HPV-039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV-039 (NCT00779766). |
| Secondary | Incidence Rates of Incident Cervical Infection With Any Oncogenic HPV Type or Combination of Oncogenic HPV Types in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. HRW-HPV = High-risk (oncogenic) HPV types without HPV-16 or HPV-18: HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. For single type: Subjects DNA negative at Month 0 for the corresponding HPV type in NCT00779766 study. For combined types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least 1 single type) in NCT00779766 study. |
Source ClinicalTrials.gov
Outcomes9
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 Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Analysis was performed on all subjects who received at least one dose of HPV vaccine (Vacc-092 Group) in the current study and for whom safety data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Analysis was performed on all subjects who received at least one dose of HPV vaccine (Vacc-092 Group) in the current study and for whom safety data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Analysis was performed on pregnant subjects from the Vacc-092 Group in the current study and for whom pregnancy outcomes data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With SAEs in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Analysis was performed on all subjects who received at least one dose of HPV vaccine (Vacc-092 Group) in the current study and for whom safety data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group | During the entire study period (Day 1-Month 12) | Analysis was performed on all subjects who received at least one dose of HPV vaccine (Vacc-092 Group) in the current study and for whom safety data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With SAEs Related to Study Participation in All Study Groups | During the entire study period (Day 1-Month 12) | Analysis was performed on the Total Enrolled Set, which included all subjects enrolled in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative and Seronegative Subjects at Baseline in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | Analysis was performed on all subjects who participated in the current study, who were HPV DNA negative and seronegative at baseline \[at Month 0 in HPV-039 (NCT00779766) study\] and who had cervical samples collected data. | events per 100 person-years | NUMBER |
| SECONDARY | Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | Analysis was performed on all subjects who participated in the current study, who were HPV DNA negative at baseline \[at Month 0 in HPV-039 (NCT00779766) study\] regardless of initial serostatus and who had cervical samples collected data. | events per 100 person-years | NUMBER |
| SECONDARY | Incidence Rates of Incident Cervical Infection With Any Oncogenic HPV Type or Combination of Oncogenic HPV Types in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups | From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study) | Analysis was performed on all subjects who participated in the current study, who were HPV DNA negative at baseline \[at Month 0 in HPV-039 (NCT00779766) study\] regardless of initial serostatus and who had cervical samples collected data. | events per 100 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group62
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 Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group | Vacc-092 Group | 0 | Participants | ||
| Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group | Vacc-092 Group | 1 | Participants | ||
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Live infant no apparent CA | 2 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Live infant CA | 0 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Elective termination no apparent CA | 8 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Elective termination CA | 0 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Spontaneous abortion no apparent CA | 0 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Spontaneous abortion CA | 0 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Stillbirth no apparent CA | 0 | Participants | |
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Vacc-092 Group | Stillbirth CA | 0 | Participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vacc-039 Group | 1,671 | |
| Overall Study | STARTED | Vacc-092 Group | 1,866 | |
| Overall Study | COMPLETED | Vacc-039 Group | 1,671 | |
| Overall Study | COMPLETED | Vacc-092 Group | 1,686 | |
| Overall Study | NOT COMPLETED | Vacc-039 Group | 0 | |
| Overall Study | NOT COMPLETED | Vacc-092 Group | 180 |
Source ClinicalTrials.gov
Adverse events4
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 | Vitiligo | Skin and subcutaneous tissue disorders | Vacc-039 Group | 0 | 0 | 0 |
| other | Vitiligo | Skin and subcutaneous tissue disorders | Vacc-092 Group | 1 | 1,791 | 1 |
| serious | Appendicitis | Infections and infestations | Vacc-039 Group | 0 | 1,671 | 0 |
| serious | Appendicitis | Infections and infestations | Vacc-092 Group | 1 | 1,866 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vacc-039 Group | 0 | 1,671 |
| Total, all-cause mortality | Vacc-092 Group | 0 | 1,866 |
| Total, other adverse events | Vacc-039 Group | 0 | 0 |
| Total, other adverse events | Vacc-092 Group | 1 | 1,791 |
| Total, serious adverse events | Vacc-039 Group | 0 | 1,671 |
| Total, serious adverse events | Vacc-092 Group | 1 | 1,866 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36101936 | BACKGROUND |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vacc-039 Group vs Vacc-092 Group: deaths from any cause | Trial comparisons |
| Vacc-039 Group vs Vacc-092 Group: Number of Subjects With SAEs Related to Study Participation in All Study Groups | Trial comparisons |
| Vacc-039 Group vs Vacc-092 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03629886/results?page=2