Infections, PapillomavirusPhase 3NCT00652938
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects
A Phase 3 study testing HPV Vaccine (GSK580299) Cervarix TM and Engerix B in people with Infections, Papillomavirus, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Read more about this study
- Who is it for?
- Ages 9 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- HPV Vaccine (GSK580299) Cervarix TM and Engerix B
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 9 Apr 2008to 8 Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/LAR prior to the enrolment. In addition, written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche (begin menstruating) during the study, and therefore become of childbearing potential, must agree to follow the same precautions.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
Show all 17Show fewer
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- Previous administration of components of the investigational vaccine.
- Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
- History of hepatitis B infection.
- Known exposure to hepatitis B within the previous 6 weeks.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden5 sites
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Luleå, SE-972 31
GSK Investigational Site
Malmö, SE-211 52
GSK Investigational Site
Norrköping, SE-601 82
GSK Investigational Site
Skene, SE-511 62
Netherlands2 sites
GSK Investigational Site
Nijmegen, 6525 GA
GSK Investigational Site
Rotterdam, 3011 EN
About this study
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) Co-administrated With a Commercially Available Vaccine in Healthy Female Adolescents
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
- Conditions
- Infections, Papillomavirus
- Being tested
- HPV Vaccine (GSK580299) Cervarix TM, Engerix B
- Keywords
- Co-administration, HPV vaccine, Cervical cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Vaccine (GSK580299) Cervarix TMBiological
IM administration
Engerix BBiological
IM administration
| Study group | Role | What they receive |
|---|---|---|
| Cervarix & Engerix Group | Active comparator | Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Receives: Biological: HPV Vaccine (GSK580299) Cervarix TM; Biological: Engerix B |
| Cervarix Group | Experimental | Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. Receives: Biological: HPV Vaccine (GSK580299) Cervarix TM |
| Engerix Group | Active comparator | Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Receives: Biological: Engerix B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.
Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Measured: Month 7
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion
Only groups which had received the HPV vaccine were included in the analysis.
Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
Measured: Month 7
Anti-HPV-16/18 Antibody Titres
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).
Only groups which had received the HPV vaccine were included in the analysis.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
Measured: Month 7
Secondary outcomes (17)
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL.
Measured: Month 7
Anti-HBs Antibody Titres
Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Measured: Month 7
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion
Only groups which had received the HPV vaccine were included in the analysis.
Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
Measured: Month 2
Anti-HPV-16/18 Antibody Titres
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).
Only groups which had received the HPV vaccine were included in the analysis.
Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
Measured: Month 2
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL.
Measured: Month 2
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.
Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Measured: Month 2
Anti-HBs Antibody Titers
Anti-HBs antibody titers are given as GMTs in mIU/mL.
Only groups which had received the HBV vaccine were included in the analysis.
Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.
Measured: Month 2
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms included injection site pain, redness and swelling.
Any solicited local symptom is occurence of a symptom regardless of its intensity.
Measured: During the 7-day period (Days 0 - 6) following vaccination
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Solicited local symptoms include injection site pain, redness and swelling.
Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm.
Measured: During the 7-day period (Days 0-6) following vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination.
Measured: During the 7-day (Days 0-6) period following vaccination.
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.
Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas.
Measured: During the 7-day (Days 0-6) period following vaccination
Number of Subjects Reporting Related Solicited General Symptoms
Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.
Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination.
Measured: During the 7-day period (Days 0 - 6) following vaccination
Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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.
Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination.
Measured: During the 30-day period (Days 0 - 29) following any vaccination
Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (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.
Related SAEs were SAEs assessed by the investigators as related to the vaccination.
- Grade 3 SAEs were not assessed.
Measured: Throughout the active phase of the study (up to Month 7).
Number of Subjects Reporting Any and Causally Related to Vaccination 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.
- Grade 3 SAEs were not assessed.
Measured: Throughout the safety follow-up (month 7 up to Month 12).
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions (i.e., 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).
Measured: Throughout the active phase of the study (up to Month 7)
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions (i.e., 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).
Measured: Throughout the safety follow-up (month 7 up to Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study start9 Apr 2008
- Primary completion28 Aug 2009
- Study completion8 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652938
- Sponsor's protocol ID
- 111507
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2008
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Schmeink C et al. Co-administration of AS04-adjuvanted human papillomavirus-16/18 vaccine with hepatitis B vaccine in healthy female subjects aged 9-15 years. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
Schmeink CE, Bekkers RL, Josefsson A, Richardus JH, Berndtsson Blom K, David MP, Dobbelaere K, Descamps D. Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls. Vaccine. 2011 Nov 15;29(49):9276-83. doi: 10.1016/j.vaccine.2011.08.037. Epub 2011 Aug 19.
PubMed 21856349Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) Co-administrated With a Commercially Available Vaccine in Healthy Female Adolescents
- ClinicalTrials.gov ID
- NCT00652938
- Acronym / sponsor ID
- 111507
- Conditions
- Infections, Papillomavirus
- Keywords
- Co-administration, HPV vaccine, Cervical cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2008
- Primary completion
- 28 Aug 2009 (actual)
- Study completion
- 8 Jan 2010 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Posted 31 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervarix & Engerix Group | Active comparator | Biological: HPV Vaccine (GSK580299) Cervarix TM, Biological: Engerix BSubjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
| Cervarix Group | Experimental | Biological: HPV Vaccine (GSK580299) Cervarix TMSubjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. |
| Engerix Group | Active comparator | Biological: Engerix BSubjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/LAR prior to the enrolment. In addition, written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Vaccine (GSK580299) Cervarix TMIM administration | Biological | Cervarix & Engerix Group, Cervarix Group |
| Engerix BIM administration | Biological | Cervarix & Engerix Group, Engerix Group |
Primary outcome
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Time frame: Month 7
Only groups which had received the HBV vaccine were included in the analysis. Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination. Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion
Time frame: Month 7
Only groups which had received the HPV vaccine were included in the analysis. Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
Anti-HPV-16/18 Antibody Titres
Time frame: Month 7
Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs). Only groups which had received the HPV vaccine were included in the analysis. Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.
17 secondary outcomes
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion
Time frame: Month 7
Anti-HBs Antibody Titres
Time frame: Month 7
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion
Time frame: Month 2
Anti-HPV-16/18 Antibody Titres
Time frame: Month 2
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion
Time frame: Month 2
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Time frame: Month 2
Anti-HBs Antibody Titers
Time frame: Month 2
Number of Subjects Reporting Any Solicited Local Symptoms
Time frame: During the 7-day period (Days 0 - 6) following vaccination
Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Time frame: During the 7-day period (Days 0-6) following vaccination
Number of Subjects Reporting Any Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period following vaccination.
Number of Subjects Reporting Grade 3 Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) period following vaccination
Number of Subjects Reporting Related Solicited General Symptoms
Time frame: During the 7-day period (Days 0 - 6) following vaccination
Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Time frame: During the 30-day period (Days 0 - 29) following any vaccination
Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)
Time frame: Throughout the active phase of the study (up to Month 7).
Number of Subjects Reporting Any and Causally Related to Vaccination SAEs
Time frame: Throughout the safety follow-up (month 7 up to Month 12).
Number of Subjects Reporting Medically Significant Conditions
Time frame: Throughout the active phase of the study (up to Month 7)
Number of Subjects Reporting Medically Significant Conditions
Time frame: Throughout the safety follow-up (month 7 up to Month 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSchmeink C et al. Co-administration of AS04-adjuvanted human papillomavirus-16/18 vaccine with hepatitis B vaccine in healthy female subjects aged 9-15 years. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
- Background: PubMed 21856349Schmeink CE, Bekkers RL, Josefsson A, Richardus JH, Berndtsson Blom K, David MP, Dobbelaere K, Descamps D. Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls. Vaccine. 2011 Nov 15;29(49):9276-83. doi: 10.1016/j.vaccine.2011.08.037. Epub 2011 Aug 19.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HPV Vaccine (GSK580299) Cervarix TM and Engerix B in people with Infections, Papillomavirus, run by GlaxoSmithKline at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection (time frame: Month 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00652938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.