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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418937
Other study ID # 114379
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 29, 2012
Est. completion date January 9, 2015

Study information

Verified date June 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date January 9, 2015
Est. primary completion date January 9, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 26 Years and older
Eligibility Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of the protocol.

- A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older.

- Written informed consent must be obtained from the subject prior to enrollment.

- Free of obvious health problems as established by medical history and clinical examination before entering into the study.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased.

- A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose.

- 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.

- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.

- 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 of each dose of the vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrollment will be deferred until the subject is outside of specified window.

- 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.

- Previous administration of vaccine components.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

- Cancer or autoimmune disease under treatment.

- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

- History of any neurological disorders or seizures.

- Acute disease and/or fever at the time of enrollment. Enrollment will be deferred until condition is resolved.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CervarixTM (GSK580299)
Three intramuscular injections

Locations

Country Name City State
Brazil GSK Investigational Site Campinas
Brazil GSK Investigational Site Curitiba
Brazil GSK Investigational Site Fortaleza
Brazil GSK Investigational Site Porto Alegre Rio Grande Do Sul
Brazil GSK Investigational Site São Paulo

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Serious Adverse Events (SAEs) Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Throughout the study period (from Month 0 up to Month 12)
Primary Number of Subjects With Potential Immune-mediated Disease (pIMDs) Throughout the study period (from Month 0 up to Month 12)
Primary Number of Subjects With Medically Significant Conditions (MSCs) MSCs include 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. Throughout the study period (from Month 0 up to Month 12)
Primary Number of Pregnant Subjects Reporting Pregnancy Outcomes The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births. Throughout the study period (from Month 0 up to Month 12)
See also
  Status Clinical Trial Phase
Terminated NCT01290393 - Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
Completed NCT00369824 - Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects Phase 3
Completed NCT00345878 - Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years Phase 3
Completed NCT00947115 - Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects Phase 3
Completed NCT01187927 - Drug Use Investigation for Cervarix® N/A
Completed NCT00169494 - Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18 Phase 3
Completed NCT01190176 - Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects Phase 3
Completed NCT00359619 - Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine Phase 2
Completed NCT00196937 - Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18 Phase 3
Completed NCT00534638 - Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents Phase 4
Completed NCT00250276 - Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. Phase 3
Completed NCT01031069 - Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females Phase 4
Completed NCT00996125 - Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects Phase 3
Completed NCT00779766 - Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects Phase 3
Completed NCT01953822 - Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom N/A
Completed NCT01153906 - Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination N/A
Completed NCT01207999 - Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer N/A
Completed NCT00693615 - Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females Phase 2
Completed NCT00693966 - Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females Phase 2
Completed NCT00541970 - Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs Phase 1