- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01031069
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Campinas, Brazil, 13083-970
- GSK Investigational Site
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Rio de Janeiro, Brazil, 21040-360
- GSK Investigational Site
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São Paulo, Brazil, 03015000
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
- GSK Investigational Site
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- GSK Investigational Site
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Kohtla-Järve, Estonia, 30322
- GSK Investigational Site
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Tallinn, Estonia, 10617
- GSK Investigational Site
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Chennai, India, 600113
- GSK Investigational Site
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Kolkata, India, 700026
- GSK Investigational Site
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Mumbai, India, 400014
- GSK Investigational Site
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Pune, India, 411001
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Bangkok, Thailand, 10330
- GSK Investigational Site
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Chiangmai, Thailand, 50200
- GSK Investigational Site
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Khon Kaen, Thailand, 40002
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol.
- A female between, and including, 15 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject and/or from the subject's parent or LAR.
- Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.
For HIV seropositive subjects:
- Subjects must be HIV seropositive according to World Health Organization (WHO) case definition.
- Subject must be asymptomatic (or only have persistent generalized lymphadenopathy).
- Subjects should have a CD4 cell count > 350 cells/mm3.
- If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry.
For HIV seronegative subjects:
- Subjects confirmed as HIV seronegative at the screening visit.
For non-virgin female subjects:
- Subjects must have no history of abnormal cytology or CIN 1/2/3.
- Subjects must have had no more than six life-time sexual partners prior to enrollment.
- Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.
- 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 at screening and on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
Exclusion Criteria:
- Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24).
- ART not compliant with the National Guidelines.
- Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects).
- Current TB therapy.
- Hemoglobin < 8.0 g/dL at the screening visit.
- Creatinine > 1.5-fold the upper limit of normal (ULN) at the screening visit.
- Alanine aminotransferase (ALT) > 2.5-fold ULN at the screening visit.
- 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 (Day 0 to Month 24).
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0 - 29) before the first dose of study vaccine/control. Enrollment will be postponed until the subject is outside the specified window.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0 - 29) any dose of study vaccine.
- Previous administration of components of the investigational vaccine.
- Cancer or autoimmune disease under treatment.
- Hypersensitivity to latex.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
- Acute disease and/or fever at the time of enrollment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
- History of any neurological disorders or seizures.
- Pregnant or breastfeeding female.
- 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, up to two months after the last vaccine dose (i.e., up to Month 8).
- Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrollment will be postponed until the subject is outside the specified window.
- Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control.
- Current drugs or alcohol abuse.
- Child in care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: HIV+/Cervarix Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
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Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Names:
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ACTIVE_COMPARATOR: HIV+/Gardasil Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
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Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Names:
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EXPERIMENTAL: HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
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Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Names:
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ACTIVE_COMPARATOR: HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
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Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Assessed solicited local symptoms were pain, redness, swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = significant pain at rest, pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
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During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria.
Any = occurrence of the symptom regardless of intensity grade and relationship.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = temperature > 39.0 °C.
Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time Frame: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
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Number of HIV+ Subjects With Serious Adverse Events (SAEs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV+ Subjects With Medically Significant Conditions (MSCs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.)
no apparent congenital anomaly, elective termination (termin.)
congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.)
anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophilis [BSPH], creatinine [CRT], eosinophils [ESPH], haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP], monocytes [MONO], neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC].
Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Month 7 (30 days after the last vaccination dose at Month 6)
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Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
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At Month 7 (30 days after the last vaccination dose at Month 6)
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HIV Viral Load (VL) in HIV+ Subjects at Month 7
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
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At Month 7 (30 days after the last vaccination dose at Month 6)
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Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].
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At Month 7 (30 days after the last vaccination dose at Month 6)
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Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects. Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline). |
At Month 7 (30 days after the last vaccination dose at Month 6)
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Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline). |
At Month 7 (30 days after the last vaccination dose at Month 6)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Assessed solicited local symptoms were pain, redness, swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = significant pain at rest, pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
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During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria.
Any = occurrence of the symptom regardless of intensity grade and relationship.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 temperature = temperature > 39.0 °C.
Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
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Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 symptom = symptom that prevented normal activity.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
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Number of HIV- Subjects With Serious Adverse Events (SAEs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV- Subjects With Medically Significant Conditions (MSCs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)
Time Frame: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)
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Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Time Frame: During the entire study period (from Day 0 up to Month 24)
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Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.)
no apparent congenital anomaly, elective termination (termin.)
congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.)
anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
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During the entire study period (from Day 0 up to Month 24)
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Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
Time Frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophils [BSPH], creatinine [CRT], eosinophils [ESPH].
Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
Time Frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Among assessed haematological parameters were: haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP] and monocytes [MONO].
Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
Time Frame: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Among assessed haematological parameters were: neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC].
Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24
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Number of Subjects With SAEs
Time Frame: During the entire study period (from Day 0 up to Month 24)
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SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
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During the entire study period (from Day 0 up to Month 24)
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Number of Subjects With Medically Significant Conditions (MSCs)
Time Frame: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
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Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
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From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
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Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Time Frame: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
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Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)
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Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
Time Frame: At Months 12, 18 and 24
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CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
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At Months 12, 18 and 24
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HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
Time Frame: At Months 12, 18 and 24
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HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
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At Months 12, 18 and 24
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Number of HIV+ Subjects by WHO HIV Clinical Staging
Time Frame: At Months 12, 18 and 24
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HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].
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At Months 12, 18 and 24
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Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC
Time Frame: At Month 7 (30 days after the last vaccination dose at Month 6)
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Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], for HIV- subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline). |
At Month 7 (30 days after the last vaccination dose at Month 6)
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
Time Frame: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
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Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.
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At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
Time Frame: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
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Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.
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At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24
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Frequency of Specific B-cells for HPV-16/18 Antigens
Time Frame: At Day 0, Week 6, Week 10, Month 7 and Month 12
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B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay.
The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
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At Day 0, Week 6, Week 10, Month 7 and Month 12
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Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
Time Frame: At Day 0, Week 6, Week 10, Month 7 and Month 12
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The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS).
The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
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At Day 0, Week 6, Week 10, Month 7 and Month 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 109823
- 2013-003429-28 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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GlaxoSmithKlineCompletedHuman Papillomavirus InfectionBahrain
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Centre Hospitalier Universitaire de BesanconCompletedHuman Papillomavirus InfectionFrance
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University Hospital, GenevaCompletedHuman Papillomavirus InfectionSwitzerland
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University of ConnecticutCompletedHuman Papillomavirus Infection
Clinical Trials on GSK Biologicals' HPV vaccine 580299
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GlaxoSmithKlineCompletedInfections, PapillomavirusGermany, Taiwan, Thailand, Canada, Italy
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GlaxoSmithKlineCompletedInfections, Papillomavirus | Papillomavirus VaccinesBelgium
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GlaxoSmithKlineCompletedInfections, PapillomavirusBelgium
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GlaxoSmithKlineCompletedInfections, PapillomavirusUnited States
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GlaxoSmithKlineCompletedInfections, PapillomavirusGermany, Spain, France
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GlaxoSmithKlineCompletedInfections, PapillomavirusChina
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GlaxoSmithKlineCompletedInfections, PapillomavirusGermany, Canada
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GlaxoSmithKlineCompletedInfections, Papillomavirus | Papillomavirus VaccinesUnited States
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GlaxoSmithKlineCompletedCervical Intraepithelial Neoplasia | Papillomavirus InfectionTaiwan, Germany, Colombia, Honduras, Panama
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GlaxoSmithKlineCompletedInfluenzaUnited States