Trial Outcomes & Findings for A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females (NCT NCT00549900)
NCT ID: NCT00549900
Last Updated: 2018-07-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Throughout the study period (up to Month 7)
Results posted on
2018-07-20
Participant Flow
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period (up to Month 7)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.
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Events
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Day 0-6) period following each vaccinationSolicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
26 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
16 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
9 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Day 0-6) period following each vaccinationSolicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Arthralgia
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
10 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Axillary fever greater than 37 degrees Celcius
|
1 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Gastrointestinal symptoms
|
4 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Myalgia
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Rash
|
1 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Urticaria
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 30 days (Day 0-29) after any vaccinationAn 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.
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
4 Participants
|
PRIMARY outcome
Timeframe: At Month 0 and Month 7Population: Analysis was performed on subjects from the Total vaccinated cohort that completed the study.
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".
Outcome measures
| Measure |
Cervarix Group
n=29 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
ALT Above [Month 7]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
ALT Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Basophils Above [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Basophils Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Basophils Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Eosinophils Above [Month 0]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Eosinophils Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Eosinophils Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Eosinophils Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hematocrit Above [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Lymphocytes Above [Month 0]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Lymphocytes Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Lymphocytes Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Lymphocytes Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Monocytes Above [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Monocytes Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Monocytes Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Monocytes Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Neutrophils Above [Month 0]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Neutrophils Below [Month 0]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Neutrophils Above [Month 7]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Neutrophils Below [Month 7]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Platelets Above [Month 0]
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Platelets Below [Month 0]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Platelets Above [Month 7]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Platelets Below [Month 7]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Red blood cells Above [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Red blood cells Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Red blood cells Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Red blood cells Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
White blood cells Above [Month 0]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
White blood cells Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
White blood cells Above [Month 7]
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
White blood cells Below [Month 7]
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
ALT Above [Month 0]
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
ALT Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Basophils Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Creatinine Above [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Creatinine Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Creatinine Above [Month 7]
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Creatinine Below [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hematocrit Below [Month 0]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hematocrit Above [Month 7]
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hematocrit Below [Month 7]
|
13 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period (up to Month7)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.
Outcome measures
| Measure |
Cervarix Group
n=30 Participants
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Number of Subjects Reporting Medically Significant Adverse Events
|
2 Participants
|
Adverse Events
Cervarix Group
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=30 participants at risk
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.3%
1/30
|
Other adverse events
| Measure |
Cervarix Group
n=30 participants at risk
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|
|
General disorders
Pain
|
86.7%
26/30
|
|
General disorders
Redness
|
53.3%
16/30
|
|
General disorders
Swelling
|
30.0%
9/30
|
|
General disorders
Arthralgia
|
6.7%
2/30
|
|
General disorders
Fatigue
|
33.3%
10/30
|
|
General disorders
Gastrointestinal symptoms
|
13.3%
4/30
|
|
General disorders
Headache
|
26.7%
8/30
|
|
General disorders
Myalgia
|
23.3%
7/30
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER