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Infections, PapillomavirusPhase 3NCT00369824

Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

A Phase 3 study testing Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM and Boostrix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 50 sites in United States.

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 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 11 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM and Boostrix TM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,330 participants
Where
50 sitesUnited States
Study dates
26 Sep 2006to 13 Feb 2008
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 11 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, 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, 11 and 18 years of age at the time of the first vaccination.
  • Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age.
  • Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
  • Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
  • Subjects must have a negative urine pregnancy test.
  • Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • 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 up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • A woman 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 24Show 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
  • Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
  • Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
  • Previous vaccination against Neisseria meningitidis.
  • Hypersensitivity to latex.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
  • History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
  • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
  • Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
  • Seizures with or without fever within three days of a prior dose of DTP vaccine.
  • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
  • Previous history of Guillain-Barré syndrome.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • GSK Investigational Site

    Akron, Ohio, 44308

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Arkansas City, Kansas, 67005

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Boardman, Ohio, 44512

  • GSK Investigational Site

    Bossier City, Louisiana, 71111

  • GSK Investigational Site

    Burke, Virginia, 22015

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Charleston, South Carolina, 29401

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Cleveland, Ohio, 44118

  • GSK Investigational Site

    Cocoa Beach, Florida, 32931

  • GSK Investigational Site

    Edison, New Jersey, 08817

  • GSK Investigational Site

    Erie, Pennsylvania, 16501

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Golden, Colorado, 80401

  • GSK Investigational Site

    Gray, Tennessee, 37615

  • GSK Investigational Site

    Greenville, Pennsylvania, 16125

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Laurinburg, North Carolina, 28352

  • GSK Investigational Site

    Lenexa, Kansas, 66219

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Madera, California, 93637

  • GSK Investigational Site

    Marietta, Georgia, 30062

  • GSK Investigational Site

    Mesa, Arizona, 85203

  • GSK Investigational Site

    Milford, Massachusetts, 01757

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Niles, Michigan, 49120

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15220

  • GSK Investigational Site

    Portland, Oregon, 97216

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Rochester, New York, 14620

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    San Angelo, Texas, 76904

  • GSK Investigational Site

    Stevensville, Michigan, 49127

  • GSK Investigational Site

    Sylva, North Carolina, 28779

  • GSK Investigational Site

    Thornton, Colorado, 80233

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Vienna, Virginia, 22180

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Whitehouse Station, New Jersey, 08889

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years

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/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Being tested
Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM, Boostrix TM
Keywords
HPV, HPV, diptheria, pertussis, tetanus, meningitis
Medical subject headings
Papillomavirus Infections, Whooping Cough, Tetanus, Meningitis

What participants receive

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

  • Different formulations of GSK Biologicals' HPV vaccine (580299)Biological

    Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively

  • Menactra TMBiological

    One dose of vaccine administered intramuscularly

  • Boostrix TMBiological

    One dose of vaccine administered intramuscularly

Study groups in NCT00369824
Study groupRoleWhat they receive
Cervarix + Boostrix/Menactra GroupExperimentalSubjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299); Biological: Menactra TM; Biological: Boostrix TM
Cervarix + Menactra/Boostrix GroupExperimentalSubjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299); Biological: Menactra TM; Biological: Boostrix TM
Cervarix + Boostrix + Menactra GroupExperimentalSubjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299); Biological: Menactra TM; Biological: Boostrix TM
Boostrix/Cervarix GroupExperimentalSubjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299); Biological: Menactra TM; Biological: Boostrix TM
Menactra/Cervarix GroupExperimentalSubjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299); Biological: Menactra TM
Cervarix GroupExperimentalSubjects received Cervarix at Months 0, 1 and 6.
Receives: Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)

What is being measured

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

  1. Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)

    Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)

    Measured: Before and one month after vaccination with Boostrix

  2. Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies

    Concentrations given as Geometric Means Concentrations (GMCs)

    Measured: Before and one month after vaccination with Boostrix

  3. Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies

    Titers given as Geometric Mean Titers (GMTs)

    Measured: Before and one month after vaccination with Menactra

Secondary outcomes (12)

  1. Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values

    Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.

    Measured: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)

  2. Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)

    Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)

    Measured: Before and one month after vaccination with Boostrix

  3. Concentration of Anti-D and Anti-T Antibodies

    Concentrations given as Geometric Mean Concentrations (GMCs)

    Measured: Before and one month after vaccination with Boostrix

  4. Number of Subjects With Booster Response for Anti-D and Anti-T

    Booster responses for anti-D and anti-T defined as:

    • For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)
    • For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer

    Measured: One month after vaccination with Boostrix

  5. Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN

    Booster responses defined as:

    • For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
    • For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
    • For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer

    Measured: One month after vaccination with Boostrix

  6. Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response

    Vaccine responses for anti-A, C, Y and W-135 defined as:

    • For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)
    • For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer

    Measured: One month after vaccination with Menactra

  7. Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling.

    Measured: During the 7-day period following each vaccination

  8. Number of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria

    Measured: During the 7-day period following each vaccination

  9. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

    Measured: During the 30-day period following each vaccination

  10. Number of Subjects Reporting Serious Adverse Events

    Serious adverse events assessed include medical occurrences that results in death, is 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: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)

  11. Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)

    NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes

    Measured: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)

  12. Number of Subjects Reporting Medically Significant Adverse Events (AEs)

    Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.

    Measured: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or 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 posted29 Aug 2006 (estimated)
  2. Study start26 Sep 2006
  3. Primary completion22 Nov 2007
  4. Study completion13 Feb 2008

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
1,330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369824
Sponsor's protocol ID
107682
Status last verified
Nov 2016
First submitted
28 Aug 2006
Last updated
20 Jul 2018
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

  • Wheeler CM, Harvey BM, Pichichero ME, Simon MW, Combs SP, Blatter MM, Marshall GS, Catteau G, Dobbelaere K, Descamps D, Dubin G, Schuind A. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine coadministered with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine and/or meningococcal conjugate vaccine to healthy girls 11 to 18 years of age: results from a randomized open trial. Pediatr Infect Dis J. 2011 Dec;30(12):e225-34. doi: 10.1097/INF.0b013e31822d28df.

    PubMed 21817954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM and Boostrix TM in people with Infections, Papillomavirus, run by GlaxoSmithKline at 50 sites in United States.

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 7 inclusion and 24 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. 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 8 Oct 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 With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) (time frame: Before and one month after vaccination with Boostrix). 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 NCT00369824, which also lists 1 linked publication.

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 20 Jul 2018.

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