- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534638
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Kotka, Finland, 48100
- GSK Investigational Site
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Kuopio, Finland, 70100
- GSK Investigational Site
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Lahti, Finland, 15110
- GSK Investigational Site
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Rauma, Finland, 26100
- GSK Investigational Site
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Tampere, Finland, 33100
- GSK Investigational Site
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Turku, Finland, 20100
- 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:
- Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.
A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.
Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study.
- Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse).
- Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement.
- If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Previous vaccination against HPV or Hepatitis B virus.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).)
- Pregnant or lactating female.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cervarix/Engerix-B A Group
The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine.
To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix).
Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination).
Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
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Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
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Experimental: Cervarix/Engerix-B B Group
The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine.
To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix).
In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine.
Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females).
Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
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Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
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Active Comparator: Engerix-B Group
In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine.
Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
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Intramuscular injection, 3 doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group
Time Frame: At the time of Visit 5 (i.e. at 18.5 years of age)
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The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering.
The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
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At the time of Visit 5 (i.e. at 18.5 years of age)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group
Time Frame: At the time of Visit 5 (i.e. at 18.5 years of age)
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The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group). Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure. |
At the time of Visit 5 (i.e. at 18.5 years of age)
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Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types
Time Frame: At the time of Visit 5 (i.e. at 18.5 years of age)
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The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering.
The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
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At the time of Visit 5 (i.e. at 18.5 years of age)
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Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types
Time Frame: At the time of Visit 5 (i.e. at 18.5 years of age)
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The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering.
The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
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At the time of Visit 5 (i.e. at 18.5 years of age)
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Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types
Time Frame: At the time of Visit 5 (at 18.5 years of age)
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The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering.
The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
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At the time of Visit 5 (at 18.5 years of age)
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Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects
Time Frame: During the 7-day post-vaccination period following each dose and across doses
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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During the 7-day post-vaccination period following each dose and across doses
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Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects
Time Frame: During the 7-day post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day post-vaccination period following each dose and across doses
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Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects
Time Frame: Within the 30-day post-vaccination period
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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 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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Within the 30-day post-vaccination period
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Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects
Time Frame: Within 30 minutes following each vaccination dose
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The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported.
Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame.
Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.
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Within 30 minutes following each vaccination dose
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Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects
Time Frame: From Dose 1 (at Day 0) until Month 12
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MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases.
Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
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From Dose 1 (at Day 0) until Month 12
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Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects
Time Frame: From Dose 1 (at Day 0) until Month 12
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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From Dose 1 (at Day 0) until Month 12
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Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination
Time Frame: During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)
Time Frame: During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.
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During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO
Time Frame: During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section. |
During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
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Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects
Time Frame: At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
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The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA).
The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
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At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
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Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects
Time Frame: At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)
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The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA).
The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
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At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lehtinen M, Eriksson T, Apter D, Hokkanen M, Natunen K, Paavonen J, Pukkala E, Angelo MG, Zima J, David MP, Datta S, Bi D, Struyf F, Dubin G. Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial. Hum Vaccin Immunother. 2016 Dec;12(12):3177-3185. doi: 10.1080/21645515.2016.1183847.
- Adhikari I, Eriksson T, Harjula K, Hokkanen M, Apter D, Nieminen P, Luostarinen T, Lehtinen M. Association of Chlamydia trachomatis infection with cervical atypia in adolescent women with short-term or long-term use of oral contraceptives: a longitudinal study in HPV vaccinated women. BMJ Open. 2022 Jun 1;12(6):e056824. doi: 10.1136/bmjopen-2021-056824.
- Gray P, Kann H, Pimenoff VN, Eriksson T, Luostarinen T, Vanska S, Surcel HM, Faust H, Dillner J, Lehtinen M. Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial. PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun.
- Kalliala I, Eriksson T, Aro K, Hokkanen M, Lehtinen M, Gissler M, Nieminen P. Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial. Prev Med. 2021 May;146:106473. doi: 10.1016/j.ypmed.2021.106473. Epub 2021 Feb 24.
- Gray P, Kann H, Pimenoff VN, Adhikari I, Eriksson T, Surcel HM, Vanska S, Dillner J, Faust H, Lehtinen M. Long-term follow-up of human papillomavirus type replacement among young pregnant Finnish females before and after a community-randomised HPV vaccination trial with moderate coverage. Int J Cancer. 2020 Dec 15;147(12):3511-3522. doi: 10.1002/ijc.33169. Epub 2020 Jul 7.
- Vanska S, Luostarinen T, Baussano I, Apter D, Eriksson T, Natunen K, Nieminen P, Paavonen J, Pimenoff VN, Pukkala E, Soderlund-Strand A, Dubin G, Garnett G, Dillner J, Lehtinen M. Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied. J Infect Dis. 2020 Aug 17;222(6):948-956. doi: 10.1093/infdis/jiaa099.
- Bi D, Apter D, Eriksson T, Hokkanen M, Zima J, Damaso S, Soila M, Dubin G, Lehtinen M, Struyf F. Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12-15 years: end-of-study results from a community-randomized study up to 6.5 years. Hum Vaccin Immunother. 2020 Jun 2;16(6):1392-1403. doi: 10.1080/21645515.2019.1692557. Epub 2019 Dec 12.
- Lehtinen M, Apter D, Eriksson T, Harjula K, Hokkanen M, Lehtinen T, Natunen K, Damaso S, Soila M, Bi D, Struyf F. Effectiveness of the AS04-adjuvanted HPV-16/18 vaccine in reducing oropharyngeal HPV infections in young females-Results from a community-randomized trial. Int J Cancer. 2020 Jul 1;147(1):170-174. doi: 10.1002/ijc.32791. Epub 2019 Dec 14.
- Lehtinen M, Luostarinen T, Vanska S, Soderlund-Strand A, Eriksson T, Natunen K, Apter D, Baussano I, Harjula K, Hokkanen M, Kuortti M, Palmroth J, Petaja T, Pukkala E, Rekonen S, Siitari-Mattila M, Surcel HM, Tuomivaara L, Paavonen J, Nieminen P, Dillner J, Dubin G, Garnett G. Gender-neutral vaccination provides improved control of human papillomavirus types 18/31/33/35 through herd immunity: Results of a community randomized trial (III). Int J Cancer. 2018 Nov 1;143(9):2299-2310. doi: 10.1002/ijc.31618. Epub 2018 Aug 10.
- Lehtinen M, Soderlund-Strand A, Vanska S, Luostarinen T, Eriksson T, Natunen K, Apter D, Baussano I, Harjula K, Hokkanen M, Kuortti M, Palmroth J, Petaja T, Pukkala E, Rekonen S, Siitari-Mattila M, Surcel HM, Tuomivaara L, Paavonen J, Dillner J, Dubin G, Garnett G. Impact of gender-neutral or girls-only vaccination against human papillomavirus-Results of a community-randomized clinical trial (I). Int J Cancer. 2018 Mar 1;142(5):949-958. doi: 10.1002/ijc.31119. Epub 2017 Nov 9.
- Lehtinen M, Apter D, Baussano I, Eriksson T, Natunen K, Paavonen J, Vanska S, Bi D, David MP, Datta S, Struyf F, Jenkins D, Pukkala E, Garnett G, Dubin G. Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial. Vaccine. 2015 Mar 3;33(10):1284-90. doi: 10.1016/j.vaccine.2014.12.019. Epub 2015 Jan 12.
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
Other Study ID Numbers
- 106636
- 2007-001731-55 (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
Study Data/Documents
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Individual Participant Data Set
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 106636Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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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