Infections, PapillomavirusPhase 3NCT00578227
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
A Phase 3 study testing Cervarix™ and Twinrix ™ Paediatric in people with Infections, Papillomavirus, run by GlaxoSmithKline at 21 sites in 4 countries.
Trial summary
Infection with human papillomavirus (HPV) has been clearly established as the central 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, and so HPV vaccination could… 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?
- Cervarix™ and Twinrix ™ Paediatric
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 15 Dec 2007to 28 Apr 2009
- 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 legally acceptable representatives (LARs) can and will comply with the requirements of the protocol 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 prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and 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.
- Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
- 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).
- 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(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
- A subject planning to become pregnant, likely to become pregnant 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 A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
- History of hepatitis A or B infection.
- Known exposure to hepatitis A or 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
21 sites in 4 countries.
21 sites in 4 countries
Hungary9 sites
GSK Investigational Site
Bordány, 6795
GSK Investigational Site
Budapest, 1032
GSK Investigational Site
Budapest, 1033
GSK Investigational Site
Budapest, 1039
GSK Investigational Site
Budapest, 1089
GSK Investigational Site
Győr, 9024
GSK Investigational Site
Hódmezővásárhely, 6800
GSK Investigational Site
Szeged, 6723
GSK Investigational Site
Szombathely, 9700
Canada5 sites
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Surrey, British Columbia, V3R 8P8
Sweden5 sites
GSK Investigational Site
Karlskrona, SE-371 41
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Lycksele, SE-921 82
GSK Investigational Site
Örebro, SE-702 11
GSK Investigational Site
Umeå, SE-901 85
Denmark2 sites
GSK Investigational Site
Hoersholm, 2970
GSK Investigational Site
Odense C, 5000
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
Infection with human papillomavirus (HPV) has been clearly established as the central 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, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
- Conditions
- Infections, Papillomavirus
- Being tested
- Cervarix™, Twinrix ™ Paediatric
- Keywords
- Human papillomavirus infection,, cervical cancer, HPV vaccine,
- 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.
Cervarix™Biological
Also called HPV vaccine, GSK Biologicals' HPV-16/18 L1 AS04
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Twinrix ™ PaediatricBiological
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
| Study group | Role | What they receive |
|---|---|---|
| Cervarix™ & Twinrix™ Group | Experimental | Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6). Receives: Biological: Cervarix™; Biological: Twinrix ™ Paediatric |
| Cervarix™ Group | Experimental | Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6). Receives: Biological: Cervarix™ |
| Twinrix™ Group | Active comparator | Subjects received 3 doses of HAB vaccine (Months 0, 1 \& 6). Receives: Biological: Twinrix ™ Paediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Measured: At Month 7
Anti-Heptatis A (HAV) Antibody Titers.
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Measured: At Month 7
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Measured: At Month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Measured: At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Measured: At Month 7
Secondary outcomes (16)
Anti-HBs Antibody Titers
Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
Measured: At Month 7
Number of Subjects Seroconverted for Anti-HBs Antibodies
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
Measured: At month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Measured: At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Measured: At Month 7
Number of Subjects Seroconverted for Anti-HAV Antibodies
Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Measured: One month after the second dose of vaccine
Anti-HAV Antibody Titers
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Measured: One month after the second dose of vaccine
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Measured: One month after the second dose of vaccine
Anti-HBs Antibody Titers
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Measured: One month after the second dose of vaccine
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Measured: One month after the second dose of vaccine
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Measured: One month after the second dose of vaccine
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
Measured: During the 7-day period (Day 0-6) following vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.
Measured: During the 7-day period following vaccination
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: Throughout the active phase of the study (up to Month 7)
Number of Subjects Reporting Medically Significant Conditions
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: Throughout the safety follow-up (from Month 7 up to Month 12)
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse events include any adverse event 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.
Measured: During the 30-day period following any vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
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.
Measured: Throughout the study (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 posted21 Dec 2007 (estimated)
- Study start15 Dec 2007
- Primary completion1 Dec 2008
- Study completion28 Apr 2009
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
- 814 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
- NCT00578227
- Sponsor's protocol ID
- 110886
- Status last verified
- Oct 2016
- First submitted
- 20 Dec 2007
- 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
Pedersen C, Breindahl M, Aggarwal N, Berglund J, Oroszlan G, Silfverdal SA, Szuts P, O'Mahony M, David MP, Dobbelaere K, Dubin G, Descamps D. Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls. J Adolesc Health. 2012 Jan;50(1):38-46. doi: 10.1016/j.jadohealth.2011.10.009.
PubMed 22188832Pederson C et al. Co-administration of ASO4- adjuvanted human papillomavirus- 16/18 cervical cancer vaccine with inactivated hepatitis A ans B vaccine in girls aged 9-15 years. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 19-22 November 2009.
Bergman 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 GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents
- ClinicalTrials.gov ID
- NCT00578227
- Acronym / sponsor ID
- 110886
- Conditions
- Infections, Papillomavirus
- Keywords
- Human papillomavirus infection,, cervical cancer, HPV vaccine,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2007
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 28 Apr 2009 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 6 Jan 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 central 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, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervarix™ & Twinrix™ Group | Experimental | Biological: Cervarix™, Biological: Twinrix ™ PaediatricSubjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A \& Hepatitis B (HAB) vaccine (Months 0, 1 \& 6). |
| Cervarix™ Group | Experimental | Biological: Cervarix™Subjects received 3 doses of HPV vaccine (Months 0, 1 \& 6). |
| Twinrix™ Group | Active comparator | Biological: Twinrix ™ PaediatricSubjects received 3 doses of HAB vaccine (Months 0, 1 \& 6). |
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 legally acceptable representatives (LARs) can and will comply with the requirements of the protocol 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 prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and 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.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
- 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).
- 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(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
- A subject planning to become pregnant, likely to become pregnant 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 |
|---|---|---|
| Cervarix™Also: HPV vaccine, GSK Biologicals' HPV-16/18 L1 AS04Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose | Biological | Cervarix™ & Twinrix™ Group, Cervarix™ Group |
| Twinrix ™ PaediatricThree doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose | Biological | Cervarix™ & Twinrix™ Group, Twinrix™ Group |
Primary outcome
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
Time frame: At Month 7
Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Anti-Heptatis A (HAV) Antibody Titers.
Time frame: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Time frame: At Month 7
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Time frame: At Month 7
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Time frame: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
16 secondary outcomes
Anti-HBs Antibody Titers
Time frame: At Month 7
Number of Subjects Seroconverted for Anti-HBs Antibodies
Time frame: At month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
Time frame: At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
Time frame: At Month 7
Number of Subjects Seroconverted for Anti-HAV Antibodies
Time frame: One month after the second dose of vaccine
Anti-HAV Antibody Titers
Time frame: One month after the second dose of vaccine
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Time frame: One month after the second dose of vaccine
Anti-HBs Antibody Titers
Time frame: One month after the second dose of vaccine
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Time frame: One month after the second dose of vaccine
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Time frame: One month after the second dose of vaccine
Number of Subjects Reporting Solicited Local Symptoms
Time frame: During the 7-day period (Day 0-6) following vaccination
Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 7-day period following vaccination
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 (from Month 7 up to Month 12)
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During the 30-day period following any vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
Time frame: Throughout the study (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.
- Background: PubMed 22188832Pedersen C, Breindahl M, Aggarwal N, Berglund J, Oroszlan G, Silfverdal SA, Szuts P, O'Mahony M, David MP, Dobbelaere K, Dubin G, Descamps D. Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls. J Adolesc Health. 2012 Jan;50(1):38-46. doi: 10.1016/j.jadohealth.2011.10.009.
- BackgroundPederson C et al. Co-administration of ASO4- adjuvanted human papillomavirus- 16/18 cervical cancer vaccine with inactivated hepatitis A ans B vaccine in girls aged 9-15 years. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 19-22 November 2009.
- 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
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cervarix™ and Twinrix ™ Paediatric in people with Infections, Papillomavirus, run by GlaxoSmithKline at 21 sites in 4 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 21 sites in Hungary, Canada, Sweden, Denmark. 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 6 Jan 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 Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies (time frame: At Month 7). The study lists 5 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 NCT00578227, 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.