AzTrials
AzTrials

Infections, PapillomavirusPhase 3NCT00637195

Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

A Phase 3 study testing Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) and Engerix™ in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female… Read more about this study

Who is it for?
Ages 20 to 25 years, women onlyHealthy volunteers can take part
What is being tested?
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) and Engerix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
2 sitesBelgium
Study dates
11 Mar 2008to 18 Jun 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 20 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 20 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and history directed clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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 Month 13), 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

2 sites in 1 country.

Belgium2 sites

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    La Louvière, 7100

Other trials in Belgium

About this study

Official title: Evaluation of the Immunogenicity and Safety of a Commercially Available Vaccine When Co-administered With GlaxoSmithKline Biologicals' HPV Vaccine (580299) in Healthy Female Subjects.

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects.

Being tested
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™), Engerix™
Keywords
Human papillomavirus (HPV) vaccine, Hepatitis B, Cervical cancer, HPV, Papillomavirus
Medical subject headings
Papillomavirus Infections, Hepatitis B, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)Biological

    Also called GSK Biologicals' HPV vaccine 580299

    Intramuscular administration, 3 doses.

  • Engerix™Biological

    Also called GSK Biologicals' vaccine 103860

    Intramuscular administration, 4 doses.

Study groups in NCT00637195
Study groupRoleWhat they receive
Cervarix™ & Engerix™ GroupExperimentalSubjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).
Receives: Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Biological: Engerix™
Engerix™ GroupActive comparatorSubjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Receives: Biological: Engerix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix

    A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).

    Measured: Month 3

  2. Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix

    Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).

    Measured: Month 3

Secondary outcomes (13)

  1. Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and 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: Months 2 and 7

  2. Anti-HPV-16/18 Antibody Titers

    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

    Measured: Months 2 and 7

  3. Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies

    Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.

    Measured: Months 2, 3 and 13

  4. Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course

    A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.

    Measured: Months 2 and 13

  5. Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course

    Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.

    Measured: At Months 2 and 13

  6. 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 following any vaccination

  7. 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 following the 4th dose of HBV vaccine

  8. Number of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

    Data are presented across doses.

    Measured: During the 7-day period following any vaccination

  9. Number of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

    Data are presented across doses.

    Measured: During the 7-day period following the 4th dose of HBV vaccine

  10. Number of Subjects Reporting Unsolicited Adverse Events

    Unsolicited adverse event covers 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

  11. Number of Subjects Reporting Unsolicited Adverse Events

    Unsolicited adverse event covers 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 the 4th dose of HBV vaccine

  12. 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: Up to study end (Month 13)

  13. 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: Up to study end (Month 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2008 (estimated)
  2. Study start11 Mar 2008
  3. Primary completion20 Jun 2008
  4. Study completion18 Jun 2009

Resources

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
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637195
Sponsor's protocol ID
111567
Other IDs
2007-007876-41
Status last verified
Dec 2019
First submitted
28 Feb 2008
Last updated
3 Jan 2020
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Leroux-Roels G, Haelterman E, Maes C, Levy J, De Boever F, Licini L, David MP, Dobbelaere K, Descamps D. Randomized trial of the immunogenicity and safety of the Hepatitis B vaccine given in an accelerated schedule coadministered with the human papillomavirus type 16/18 AS04-adjuvanted cervical cancer vaccine. Clin Vaccine Immunol. 2011 Sep;18(9):1510-8. doi: 10.1128/CVI.00539-10. Epub 2011 Jul 6.

    PubMed 21734063

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) and Engerix™ in people with Infections, Papillomavirus and Papillomavirus Vaccines, run by GlaxoSmithKline at 2 sites in Belgium.

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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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 18 Dec 2009). 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 Seroprotected Against Hepatitis B Following 3 Doses of Engerix (time frame: Month 3). The study lists 2 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 NCT00637195, which also lists 2 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 3 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in