Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

NCT00534638CompletedPHASE4INTERVENTIONAL

Summary

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

Key Facts

Lead Sponsor

GlaxoSmithKline

Enrollment

34412

Start Date

2007-10-04

Completion Date

2014-12-17

Study Type

INTERVENTIONAL

Official Title

Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Interventions

CervarixEngerix-B

Conditions

InfectionsPapillomavirus

Eligibility

Age Range

12 Years – 15 Years

Sex

ALL

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.

Outcome Measures

Primary Outcomes

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)

Secondary Outcomes

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

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.

Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)

Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types

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).

Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)

Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types

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).

Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)

Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types

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).

Time frame: At the time of Visit 5 (at 18.5 years of age)

Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects

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.

Time frame: During the 7-day post-vaccination period following each dose and across doses

Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects

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.

Time frame: During the 7-day post-vaccination period following each dose and across doses

Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects

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.

Time frame: Within the 30-day post-vaccination period

Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects

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.

Time frame: Within 30 minutes following each vaccination dose

Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects

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.

Time frame: From Dose 1 (at Day 0) until Month 12

Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects

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.

Time frame: From Dose 1 (at Day 0) until Month 12

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)

Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)

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.

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)

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO

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.

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)

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

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.

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)

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)

Locations

GSK Investigational Site, Kotka, Finland

GSK Investigational Site, Kuopio, Finland

GSK Investigational Site, Lahti, Finland

GSK Investigational Site, Rauma, Finland

GSK Investigational Site, Tampere, Finland

GSK Investigational Site, Turku, Finland

Linked Papers

2025-11-24

Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis

Cervical cancer is the fourth most common cause of cancer-related death amongst females worldwide. Persistent infection with high-risk human papillomavirus (HPV) is the key factor in cervical cancer development. HPV vaccines aim to prevent cancer by generating antibodies against HPV infection. To evaluate the safety and efficacy of HPV vaccines, in females and males, to prevent cervical cancer and other HPV-related diseases, in standard (pairwise) and network meta-analysis (NMA) of randomised controlled trials. On 10 January 2022, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase. We searched Epistemonikos, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, the Health Technology Assessment database and vaccine manufacturer websites, and we checked reference lists from other relevant systematic reviews. We applied for Clinical Study Reports (CSRs) from the European Medicines Agency. An update search of electronic databases was done on 18 September 2024. We included randomised controlled trials (RCTs) regardless of language or publication status, assessing HPV vaccines pre-qualified by the World Health Organization (WHO) (Cervarix, Gardasil, Gardasil-9 and Cecolin). We used methods recommended by Cochrane. We primarily used CSRs to collect data, and we included outcome data irrespective of participants' baseline HPV infection or serostatus. We assessed risk of bias using the Cochrane tool (RoB 2). All outcomes were dichotomous, and we estimated risk ratios (RR) with 95% confidence intervals (CI). We used pairwise analysis for all outcomes. Where data were available, we carried out NMA for critical outcomes for networks in females and males in three age groups, ranking the vaccines using surface under the cumulative ranking curve (SUCRA) and mean ranks. We assessed the certainty of evidence using the GRADE approach. We included 60 individual studies with 157,414 participants ranging in follow-up from seven months to 11 years. Few participants were under 15. There were no studies for males under 15 years and males over 25 years. We obtained CSRs for 33 of the included studies. We assessed the risk of bias as low to 'some concerns' for the critical outcomes. Cancer and pre-cancer outcomes The studies were not of sufficient duration for cancers to develop. Four studies reported on cancer. No cancers were detected. Critical pre-cancer outcomes were reported in 15- to 25-year-old populations by 11 studies and in > 25-year-old females by three studies with up to seven years follow-up. None were reported in the under 15 years age group. In 15- to 25-year-old females, there was a reduction in CIN2+ irrespective of HPV type after six years (RR 0.70, 95% CI 0.56 to 0.88) (moderate-certainty) and a larger reduction in CIN2+ from vaccine-matched HPV types after six years (RR 0.40, 95% CI 0.30 to 0.54) (moderate-certainty). In females over 25 years old, there was little to no difference between Cervarix and Gardasil compared with control (moderate-certainty). There was no evidence on CIN2+ irrespective of HPV type from studies assessing Cecolin, or from studies assessing different dose schedules. In 15- to 25-year-old females, there was a slight reduction in vaccine-matched HPV-type high-grade vulval (VIN) or vaginal (VaIN) intraepithelial neoplasia following vaccination with Gardasil or Gardasil-9 (moderate-certainty). The NMA found a slight reduction of 1 case per 1000 following Gardasil (RR 0.21, 95% CI 0.1 to 0.45) and 0 cases per 1000 following Gardasil-9 (RR 0.16, 95% CI 0.05 to 0.51). Little to no difference was found in the NMA for Cervarix compared with control (RR 0.28, 95% CI 0.06 to 1.37), or for Cervarix, Gardasil and Gardasil-9 compared to each other. There was a reduction in high-grade anal intraepithelial neoplasia (AIN) irrespective of HPV type in the Gardasil group in one study in men who have sex with men (RR 0.75, 95% CI 0.53 to 1.07) (low-certainty). For both high-grade penile intraepithelial neoplasia (PeIN) irrespective of HPV type and vaccine-matched HPV-type high-grade PeIN, little to no difference per 1000 participants was reported in the Gardasil group in one study with 3880 participants at 36 months follow-up (RR 1.00, 95% CI 0.20 to 4.93) (low-certainty). Serious adverse events In a pairwise analysis of serious adverse events in 39 studies across all vaccine types with 97,272 participants, there was little to no difference in the HPV vaccine groups compared with the control group at up to 72 months follow-up (RR 0.99, 95% CI 0.94 to 1.04) (high-certainty). Treatment rates for HPV-related pre-invasive disease In pairwise analysis of five studies with 38,606 participants, there were 12 fewer people that needed to seek treatment per 1000 participants (95% CI 5 to 17 fewer per 1000) in the HPV vaccine groups compared with the control group rate at up to 84 months follow-up (RR 0.76, 95% CI 0.65 to 0.89) (moderate-certainty). Anogenital warts In pairwise analysis of three studies with 21,271 participants, there were 25 fewer cases of anogenital warts irrespective of HPV type per 1000 participants (95% CI 22 to 28 fewer per 1000) in the HPV vaccine groups compared with the control group rate at up to 48 months follow-up (RR 0.38, 95% CI 0.32 to 0.46) (high-certainty). In the NMA for females 15 to 25 years old, Gardasil-9 was most likely to reduce the risk of developing anogenital warts. The evidence in this network meta-analysis of HPV vaccines is based on extensive searches and analyses. There is evidence from randomised controlled trials that HPV vaccination reduces the risk of pre-cancerous outcomes such as CIN2+ and anogenital warts. No data were available for cervical cancer or other cancer outcomes, and no data on pre-cancer outcomes were available for vaccination under age 15 years. There were no safety concerns noted in the studies.

2021-06-07

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

BackgroundCervical cancer elimination through human papillomavirus (HPV) vaccination programs requires the attainment of herd effect. Due to its uniquely high basic reproduction number, the vaccination coverage required to achieve herd effect against HPV type 16 exceeds what is attainable in most populations. We have compared how gender-neutral and girls-only vaccination strategies create herd effect against HPV16 under moderate vaccination coverage achieved in a population-based, community-randomized trial.Methods and findingsIn 2007–2010, the 1992–1995 birth cohorts of 33 Finnish communities were randomized to receive gender-neutral HPV vaccination (Arm A), girls-only HPV vaccination (Arm B), or no HPV vaccination (Arm C) (11 communities per trial arm). HPV16/18/31/33/35/45 seroprevalence differences between the pre-vaccination era (2005–2010) and post-vaccination era (2011–2016) were compared between all 8,022 unvaccinated women <23 years old and resident in the 33 communities during 2005–2016 (2,657, 2,691, and 2,674 in Arms A, B, and C, respectively). Post- versus pre-vaccination-era HPV seroprevalence ratios (PRs) were compared by arm. Possible outcome misclassification was quantified via probabilistic bias analysis. An HPV16 and HPV18 seroprevalence reduction was observed post-vaccination in the gender-neutral vaccination arm in the entire study population (PR16= 0.64, 95% CI 0.10–0.85; PR18= 0.72, 95% CI 0.22–0.96) and for HPV16 also in the herpes simplex virus type 2 seropositive core group (PR16= 0.64, 95% CI 0.50–0.81). Observed reductions in HPV31/33/35/45 seroprevalence (PR31/33/35/45= 0.88, 95% CI 0.81–0.97) were replicated in Arm C (PR31/33/35/45= 0.79, 95% CI 0.69–0.90).ConclusionsIn this study we only observed herd effect against HPV16/18 after gender-neutral vaccination with moderate vaccination coverage. With only moderate vaccination coverage, a gender-neutral vaccination strategy can facilitate the control of even HPV16. Our findings may have limited transportability to other vaccination coverage levels.Trial registrationClinicalTrials.gov numberNCT00534638,https://clinicaltrials.gov/ct2/show/NCT00534638.

Linked Investigators

Hanna Bergman

Hanna Kann

Joakim Dillner

Penelope Gray

Simopekka Vänskä

Tapio Luostarinen