AzTrials
AzTrials

Infections, PapillomavirusPhase 1NCT00541970

Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

A Phase 1 study testing Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 25 sites in 2 countries.

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

Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. Read more about this study

Who is it for?
Ages 9 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
Cervarix
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
961 participants
Where
25 sitesin 2 countries
Study dates
17 Oct 2007to 18 Mar 2013
Phase
Phase 1
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 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
  • Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject's parents/legally acceptable representative, and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
  • Subject 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 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 24).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Planned administration/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.
  • Pregnant or breastfeeding female.
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
Show all 15Show fewer
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
  • Previous administration of components of the investigational vaccine.
  • Cancer or autoimmune disease under treatment.
  • Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
  • 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 (up to Month 24).

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

Germany20 sites

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60439

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 22159

  • GSK Investigational Site

    Hamburg, 22525

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Hanover, Lower Saxony, 30657

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76199

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Munich, Bavaria, 80637

  • GSK Investigational Site

    Nordhausen, Thuringia, 99734

  • GSK Investigational Site

    Rheinstetten, Baden-Wurttemberg, 76287

  • GSK Investigational Site

    Tauberbischofsheim, Baden-Wurttemberg, 97941

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Weilheim, Bavaria, 82362

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38302

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Canada5 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Québec, Quebec, G1E 7G9

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Being tested
Cervarix, Placebo
Keywords
viral infections, Human Papillomavirus (HPV) vaccine, safety, vaccine, immunogenicity, cervical cancer
Medical subject headings
Papillomavirus Infections, Virus Diseases, Uterine Cervical Neoplasms

What participants receive

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

  • CervarixBiological

    Also called GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) vaccine 580299

    Intramuscular injection, different dosing /schedule

  • PlaceboDrug

    Intramuscular injection, different dosing /schedule

Study groups in NCT00541970
Study groupRoleWhat they receive
Cervarix 1/Placebo GroupExperimentalSubjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Receives: Biological: Cervarix; Drug: Placebo
Cervarix 1/Placebo/Cervarix 1 GroupExperimentalSubjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Receives: Biological: Cervarix; Drug: Placebo
Cervarix 2/Placebo/Cervarix 2 GroupExperimentalSubjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
Receives: Biological: Cervarix; Drug: Placebo
Cervarix 2 GroupExperimentalSubjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Receives: Biological: Cervarix

What is being measured

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

  1. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Measured: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).

  2. Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).

    Measured: Within 7 days (Day 0-6) after vaccination.

  3. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.

    Measured: Within 7 days (Day 0-6) after vaccination.

Secondary outcomes (33)

  1. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.

    Measured: At Month 3, 1 month after the second dose of vaccine or placebo

  2. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.

    Measured: At Month 7, 1 month after the last dose of vaccine or placebo.

  3. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Measured: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.

  4. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

    Measured: At Month 7, 1 month after the last dose of vaccine or placebo.

  5. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.

    Measured: At Month 7 (M7)

  6. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.

    Measured: At Month 7 (M7)

  7. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.

    Measured: At Month 7 (M7)

  8. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.

    Measured: At Month 7 (M7)

  9. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.

    Measured: At Month 7 (M7)

  10. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.

    Measured: At Month 7 (M7)

  11. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.

    Measured: At Month 7 (M7)

  12. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.

    Measured: At Month 7 (M7)

  13. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.

    Measured: At Month 7 (M7)

  14. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.

    Measured: At Month 7 (M7)

  15. Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

    Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.

    Measured: At Month 7 (M7)

  16. Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

    Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.

    Measured: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.

  17. Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

    Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).

    Measured: At Month 60 of the safety follow-up phase

  18. Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

    Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.

    Measured: At Month 60 of the safety follow-up phase

  19. Number of Subjects With Pregnancy Outcomes.

    Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.

    Measured: From Month 0 to Month 48.

  20. Number of Subjects With Pregnancy Outcomes.

    Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.

    Measured: Throughout the study period, from Month 0 to Month 60.

  21. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

    An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.

    Measured: Within 30 days (Day 0-29) after vaccination.

  22. Number of Subjects With Medically Significant Conditions (MSCs).

    MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.

    Measured: From Month 0 to Month 7.

  23. Number of Subjects With Medically Significant Conditions (MSCs).

    MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.

    Measured: From Month 0 to Month 48.

  24. Number of Subjects With Medically Significant Conditions (MSCs).

    MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.

    Measured: Throughout the study period, from Month 0 to Month 60.

  25. Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: From Month 0 to Month 7.

  26. Number of Subjects With New Onset of Autoimune Diseases (NOADs)

    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: From Month 0 to Month 48.

  27. Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

    NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: Throughout the study period, from Month 0 to Month 60.

  28. Number of Subjects With New Onset of Chronic Diseases (NOCDs)

    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: From Month 0 to Month 7.

  29. Number of Subjects With New Onset of Chronic Diseases (NOCDs)

    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: From Month 0 to Month 48.

  30. Number of Subjects With New Onset of Chronic Diseases (NOCDs)

    NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

    Measured: Throughout the study period, from Month 0 to Month 60.

  31. Number of Subjects With 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.

    Measured: From Month 0 to Month 7.

  32. Number of Subjects With 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.

    Measured: From Month 0 to Month 48.

  33. Number of Subjects With 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.

    Measured: Throughout the study period, from Month 0 to Month 60.

Timeline

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

  1. First posted10 Oct 2007 (estimated)
  2. Study start17 Oct 2007
  3. Primary completion18 Mar 2013
  4. Study completion18 Mar 2013

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
961 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541970
Sponsor's protocol ID
110659
Status last verified
Aug 2016
First submitted
9 Oct 2007
Last updated
17 Aug 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

  • Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, Schuind A, Descamps D. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011 Dec;7(12):1374-86. doi: 10.4161/hv.7.12.18322. Epub 2011 Dec 1.

    PubMed 22048171

  • 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

  • Folschweiller N, Behre U, Dionne M, Durando P, Esposito S, Ferguson L, Ferguson M, Hillemanns P, McNeil SA, Peters K, Ramjattan B, Schwarz TF, Supparatpinyo K, Suryakirian PV, Janssens M, Moris P, Decreux A, Poncelet S, Struyf F. Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine. J Infect Dis. 2019 May 5;219(11):1799-1803. doi: 10.1093/infdis/jiy743.

    PubMed 30715452

  • Romanowski B, Schwarz TF, Ferguson L, Peters K, Dionne M, Behre U, Schulze K, Hillemanns P, Suryakiran P, Thomas F, Struyf F. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother. 2016;12(1):20-9. doi: 10.1080/21645515.2015.1065363. Epub 2015 Jul 15.

    PubMed 26176261

  • Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.

    PubMed 24731816

  • Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, Suryakiran P, Thomas F, Struyf F. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study. Hum Vaccin Immunother. 2014;10(5):1155-65. doi: 10.4161/hv.28022. Epub 2014 Feb 27.

    PubMed 24576907

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cervarix in people with Infections, Papillomavirus, run by GlaxoSmithKline at 25 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 5 inclusion and 15 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 25 sites in Germany, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 Apr 2014). 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?

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (time frame: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: 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 NCT00541970, which also lists 6 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.

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