Last updated: 11/03/2018 09:59:40
Evaluation of safety and immunogenicity of Co-administering Human Papillomavirus (HPV) vaccine with other vaccines in healthy female subjects
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicentre study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV vaccine (580299) Co-administered with Boostrix Polio (dTpa-IPV) in healthy female subjects aged 10–18 years
Trial description: 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 IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals’ (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroprotected against diphtheria and tetanus
Timeframe: One month after vaccination with Boostrix Polio
Titers of anti-pertussis toxoid (anti-PT), anti-pertactin toxoid (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA) antibodies
Timeframe: One month after vaccination with Boostrix Polio
Number of subjects seroprotected against Poliovirus type 1 (Polio 1), Polio 2 and Polio 3
Timeframe: One month after vaccination with Boostrix Polio
Secondary outcomes:
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies after completing the Cervarix vaccination course
Timeframe: One month post Cervarix Dose 3 (Month 7/8)
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies after incomplete Cervarix vaccination course
Timeframe: One month post Dose 1
Titers of anti-human Papilloma virus 16 (anti-HPV-16) and anti-human Papilloma virus 18 (anti-HPV-18) antibodies After Completing the Cervarix Vaccination Course
Timeframe: One month post Cervarix Dose 3 (Month 7/8)]
Titers of anti-diphtheria and anti-tetanus antibodies
Timeframe: One month after vaccination with Boostrix-Polio
Number of subjects with anti-diphtheria and anti-tetanus antibody titers above 1.0 International Units per Milliliter (IU/mL)
Timeframe: One month after vaccination with Boostrix Polio
Anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibody titers
Timeframe: One month after vaccination with Boostrix Polio
Number of subjects with booster response to diphtheria and tetanus
Timeframe: One month after vaccination with Boostrix Polio
Number of subjects with booster response to pertussis toxoid (PT), pertactin toxoid (PRN) and filamentous hemagglutinin (FHA)
Timeframe: One month after vaccination with Boostrix Polio
Number of subjects reporting solicited symptoms
Timeframe: During the 7-day period (Day 0-6) following each vaccination
Number of subjects reporting unsolicited adverse events
Timeframe: During the 30-day period (Day 0-29) following vaccination
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
Timeframe: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
Number of subjects reporting serious adverse events (SAEs)
Timeframe: During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
Interventions:
Biological/vaccine: Boostrix ® Polio
Biological/vaccine: GSK Biologicals’ HPV-16/18 L1 AS04 vaccine (Cervarix TM)
Enrollment:
751
Observational study model:
Not applicable
Primary completion date:
2008-17-03
Time perspective:
Not applicable
Clinical publications:
Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
February 2007 to July 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
10 - 18 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 10 and 18 years of age at the time of the first vaccination.
- 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 (up to Month 12/13).
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 10 and 18 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 legal age of consent, written informed consent obtained from the subject’s parent/LAR, and written informed assent must be obtained from the subject.
- Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
- Previously completed routine childhood vaccinations according to the recommended vaccination schedule at the time.
- Subjects must have a negative urine pregnancy test.
- 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 must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study, and therefore become of childbearing potential, must agree to follow the same precautions.
Exclusion criteria:
- 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 (up to Month 12/13).
- Concurrently participating in another clinical study, at any time during the study period, 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 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.
- 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 diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus (Td) booster or dTpa vaccine within the previous five years.
- Administration of a pre-school booster of Oral Polio Vaccine (OPV) or Inactivated Polio Virus (IPV) vaccine (4 or 5th dose) within the previous five years.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality or thrombocytopenia, 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.
- History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
- Temperature of >=40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa), not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa).
- Seizures with or without fever within three days of a prior dose of DTP vaccine (Diphtheria, Tetanus, whole cell Pertussis vaccine DTPw and/or Diphtheria, Tetanus, acellular Pertussis vaccine DTPa).
- Persistent, inconsolable crying lasting >=3 hours, occurring within 48 hours of a prior dose of DTP vaccine (DTPw and/or DTPa).
- Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
- Known exposure to diphtheria or household exposure to pertussis within 30 days before (i.e., Day 0-29) vaccination with Diphtheria, Tetanus, acellular Pertussis and inactivated polio virus vaccine (dTpa-IPV).
- Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days before (i.e., Day 0-29) vaccination with dTpa-IPV.
- Presence of a contra-indication to vaccination according to the product leaflet of the commercially available dTpa-IPV vaccine.
- 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 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
Trial location(s)
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30657
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76199
Status
Study Complete
Location
GSK Investigational Site
Ravensburg, Baden-Wuerttemberg, Germany, 88212
Status
Study Complete
Location
GSK Investigational Site
Nordhausen, Thueringen, Germany, 99734
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Rheinstetten, Baden-Wuerttemberg, Germany, 76287
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-17-03
Actual study completion date
2008-25-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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