Trial · NCT00534638
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
NCT00534638, Phase 4, Completed, GlaxoSmithKline; results first posted 2016-01-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents. Trials, record NCT00534638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00534638
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
- NCT number
- NCT00534638
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 34,412 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Papillomavirus
- Interventions
- Cervarix, Engerix-B
- First posted
- 2007-09-26
- Last updated
- 2019-11-15
- Other registries' IDs
- eudract:2007-001731-55
- Results first posted
- 2016-01-26
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Secondary | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group). Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure. |
| Secondary | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Secondary | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Secondary | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (at 18.5 years of age) | The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Secondary | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Secondary | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Within the 30-day post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Secondary | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Within 30 minutes following each vaccination dose | The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame. |
| Secondary | Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (at 18.5 years of age) | The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Within the 30-day post-vaccination period | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Within 30 minutes following each vaccination dose | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group373
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | Cervarix/Engerix-B A Group | 139 | Participants | ||
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | Cervarix/Engerix-B B Group | 117 | Participants | ||
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | Engerix-B Group | 329 | Participants | ||
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | Cervarix/Engerix-B A Group | 139 | Participants | ||
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | Cervarix/Engerix-B B Group | 117 | Participants | ||
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | Cervarix/Engerix-B A Group | HPV-16 | 88 | Participants | |
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | Cervarix/Engerix-B B Group | HPV-16 | 85 | Participants | |
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | Engerix-B Group | HPV-16 | 227 | Participants | |
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | Cervarix/Engerix-B A Group | HPV-18 | 62 | Participants | |
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | Cervarix/Engerix-B B Group | HPV-18 | 41 | Participants |
1 to 10 of 373Source ClinicalTrials.gov
See all 373 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 Pooled Group | 14,837 | |
| Overall Study | STARTED | Engerix-B Pooled Group | 17,338 | |
| Overall Study | COMPLETED | Cervarix Pooled Group | 8,346 | |
| Overall Study | COMPLETED | Engerix-B Pooled Group | 5,547 | |
| Overall Study | NOT COMPLETED | Cervarix Pooled Group | 6,491 | |
| Overall Study | NOT COMPLETED | Engerix-B Pooled Group | 11,791 |
Source ClinicalTrials.gov
Adverse events226
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 | Pain | General disorders | Cervarix Pooled Group | 506 | 603 | |
| other | Pain | General disorders | Engerix-B Pooled Group | 251 | 1,028 | |
| other | Redness | General disorders | Cervarix Pooled Group | 169 | 603 | |
| other | Redness | General disorders | Engerix-B Pooled Group | 131 | 1,028 | |
| other | Arthralgia | General disorders | Cervarix Pooled Group | 107 | 604 | |
| other | Arthralgia | General disorders | Engerix-B Pooled Group | 97 | 1,028 | |
| other | Fatigue | General disorders | Cervarix Pooled Group | 291 | 604 | |
| other | Fatigue | General disorders | Engerix-B Pooled Group | 411 | 1,028 | |
| other | Fever (Axillary) | General disorders | Cervarix Pooled Group | 48 | 604 | |
| other | Fever (Axillary) | General disorders | Engerix-B Pooled Group | 85 | 1,028 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cervarix Pooled Group | 0 | 14,837 |
| Total, all-cause mortality | Engerix-B Pooled Group | 0 | 17,338 |
| Total, other adverse events | Cervarix Pooled Group | 506 | 643 |
| Total, other adverse events | Engerix-B Pooled Group | 411 | 1,047 |
| Total, serious adverse events | Cervarix Pooled Group | 188 | 14,837 |
| Total, serious adverse events | Engerix-B Pooled Group | 152 | 17,338 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cervarix Pooled Group vs Engerix-B Pooled Group: Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | Trial comparisons |
| Cervarix Pooled Group vs Engerix-B Pooled Group: Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO) | Trial comparisons |
| Cervarix/Engerix-B Pooled Group vs Engerix-B Group: Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | Trial comparisons |
| Cervarix Pooled Group vs Engerix-B Pooled Group: Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination | Trial comparisons |
Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | Trial comparisons |
| Cervarix Pooled Group vs Engerix-B Pooled Group: deaths from any cause | Trial comparisons |
| Cervarix Pooled Group vs Engerix-B Pooled 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.
GET https://conductscience.org/api/trials/v1/NCT00534638
GET https://conductscience.org/api/trials/v1/NCT00534638/results?page=2