A Phase 1 interventional study of GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine) in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 1 site in China. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention
A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A\&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis etc. up to 8 days before each HPV dose.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)
Intramuscular injection, 3 doses
Also known as: GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine
Number of Subjects Reporting Serious Adverse Events
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (up to Month 7)
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 7-day (Day 0-6) period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time frame: During the 7-day (Day 0-6) period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: Within 30 days (Day 0-29) after any vaccination
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".
Time frame: At Month 0 and Month 7
Number of Subjects Reporting Medically Significant Adverse Events
Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Throughout the study period (up to Month7)
| Milestone | Cervarix Group |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| Participants | Cervarix Group |
|---|---|
| Number of Subjects Reporting Serious Adverse Events | 1 |
Solicited local symptoms assessed include pain, redness and swelling.
| Participants | Cervarix Group |
|---|---|
| Pain | 26 |
| Redness | 16 |
| Swelling | 9 |
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
| Participants | Cervarix Group |
|---|---|
| Arthralgia | 2 |
| Fatigue | 10 |
| Axillary fever greater than 37 degrees Celcius | 1 |
| Gastrointestinal symptoms | 4 |
| Headache | 8 |
| Myalgia | 7 |
| Rash | 1 |
| Urticaria | 0 |
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
| Participants | Cervarix Group |
|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 4 |
Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".
| Participants | Cervarix Group |
|---|---|
| ALT Above [Month 0] | 3 |
| ALT Below [Month 0] | 0 |
| ALT Above [Month 7] | 1 |
| ALT Below [Month 7] | 0 |
| Basophils Above [Month 0] | 0 |
| Basophils Below [Month 0] | 0 |
| Basophils Above [Month 7] | 0 |
| Basophils Below [Month 7] | 0 |
| Creatinine Above [Month 0] | 0 |
| Creatinine Below [Month 0] | 0 |
| Creatinine Above [Month 7] | 3 |
| Creatinine Below [Month 7] | 0 |
| Eosinophils Above [Month 0] | 2 |
| Eosinophils Below [Month 0] | 0 |
| Eosinophils Above [Month 7] | 0 |
| Eosinophils Below [Month 7] | 0 |
| Hematocrit Above [Month 0] | 0 |
| Hematocrit Below [Month 0] | 0 |
| Hematocrit Above [Month 7] | 0 |
| Hematocrit Below [Month 7] | 13 |
| Lymphocytes Above [Month 0] | 1 |
| Lymphocytes Below [Month 0] | 0 |
| Lymphocytes Above [Month 7] | 0 |
| Lymphocytes Below [Month 7] | 0 |
| Monocytes Above [Month 0] | 0 |
| Monocytes Below [Month 0] | 0 |
| Monocytes Above [Month 7] | 0 |
| Monocytes Below [Month 7] | 0 |
| Neutrophils Above [Month 0] | 1 |
| Neutrophils Below [Month 0] | 1 |
| Neutrophils Above [Month 7] | 2 |
| Neutrophils Below [Month 7] | 2 |
| Platelets Above [Month 0] | 3 |
| Platelets Below [Month 0] | 2 |
| Platelets Above [Month 7] | 1 |
| Platelets Below [Month 7] | 1 |
| Red blood cells Above [Month 0] | 0 |
| Red blood cells Below [Month 0] | 0 |
| Red blood cells Above [Month 7] | 0 |
| Red blood cells Below [Month 7] | 0 |
| White blood cells Above [Month 0] | 2 |
| White blood cells Below [Month 0] | 0 |
| White blood cells Above [Month 7] | 2 |
| White blood cells Below [Month 7] | 1 |
Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
| Participants | Cervarix Group |
|---|---|
| Number of Subjects Reporting Medically Significant Adverse Events | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix Group | — | 1/30 (3.3%) | 26/30 (86.7%) |
| Event | Cervarix Group |
|---|---|
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/30 |
| Event | Cervarix Group |
|---|---|
| PainGeneral disorders | 26/30 |
| RednessGeneral disorders | 16/30 |
| FatigueGeneral disorders | 10/30 |
| SwellingGeneral disorders | 9/30 |
| HeadacheGeneral disorders | 8/30 |
| MyalgiaGeneral disorders | 7/30 |
| Gastrointestinal symptomsGeneral disorders | 4/30 |
| ArthralgiaGeneral disorders | 2/30 |
| Age, Continuous(years) | Cervarix Group |
|---|---|
| Mean | 28.0 ± 9.03 |
| Sex: Female, Male(Participants) | Cervarix Group |
|---|---|
| Female | 30 |
| Male | 0 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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