Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age (NCT NCT00492544)

Last Updated: 2018-09-04

Results Overview

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

One month post Dose 3 (Month 7)

Results posted on

2018-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cervarix Group Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Age, Continuous	12.1 years STANDARD_DEVIATION 1.60 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 7)

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.

Outcome measures

Outcome measures
Measure	Cervarix Group n=94 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-16	92 Participants
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-18	94 Participants

PRIMARY outcome

Timeframe: Before vaccination (PRE) and one month post Dose 3 (Month 7)

Population: Analysis was performed on the ATP cohort for immunogenicity.

Titers are given as geometric mean titers (GMTs) calculated on all subjects.

Outcome measures

Outcome measures
Measure	Cervarix Group n=99 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers Anti-HPV-16 (PRE)	4.4 titer Interval 4.1 to 4.8
Anti-HPV-16 and Anti-HPV-18 Antibody Titers Anti-HPV-16 (Month 7)	19748.0 titer Interval 17147.7 to 22742.7
Anti-HPV-16 and Anti-HPV-18 Antibody Titers Anti-HPV-18 (PRE)	3.7 titer Interval 3.5 to 3.9
Anti-HPV-16 and Anti-HPV-18 Antibody Titers Anti-HPV-18 (Month 7)	8765.3 titer Interval 7543.8 to 10184.4

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period following each vaccination

Solicited local symptoms assessed include pain, redness and swelling.

Outcome measures

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Solicited Local Symptoms Pain	98 Participants
Number of Subjects Reporting Solicited Local Symptoms Redness	85 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling	81 Participants

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) period following each vaccination

Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

Outcome measures

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Solicited General Symptoms Headache	33 Participants
Number of Subjects Reporting Solicited General Symptoms Arthralgia	15 Participants
Number of Subjects Reporting Solicited General Symptoms Fatigue	40 Participants
Number of Subjects Reporting Solicited General Symptoms Fever	10 Participants
Number of Subjects Reporting Solicited General Symptoms Gastrointestinal symptoms	17 Participants
Number of Subjects Reporting Solicited General Symptoms Myalgia	26 Participants
Number of Subjects Reporting Solicited General Symptoms Rash	5 Participants
Number of Subjects Reporting Solicited General Symptoms Urticaria	3 Participants

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) period following each vaccination

Unsolicited adverse event= 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

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Unsolicited Adverse Events (AE)	63 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 7

NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.

Outcome measures

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions Medically significant conditions	18 Participants
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions NOCDs	0 Participants

SECONDARY outcome

Timeframe: Up to Month 7

Population: There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.

According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 0 up to Month 7

Serious adverse events assessed include 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

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Serious Adverse Events (SAEs)	0 Participants

SECONDARY outcome

Timeframe: At Day 0 and Month 7

Abnormalities include values outside (above or below) the normal ranges. Normal ranges: alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL

Outcome measures

Outcome measures
Measure	Cervarix Group n=100 Participants Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above (Day 0)	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Blood urea nitrogen Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Blood urea nitrogen Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Creatinine Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters AST Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Basophils Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above (Month 7)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters AST Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters AST Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters AST Above (Month 7)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Basophils Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Basophils Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Basophils Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Blood urea nitrogen Above (Day 0)	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Blood urea nitrogen Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Creatinine Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Creatinine Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Creatinine Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Eosinophils Above (Day 0)	17 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Eosinophils Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Eosinophils Above (Month 7)	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Eosinophils Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hematocrit Above (Day 0)	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hematocrit Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hematocrit Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hematocrit Below (Month 7)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hemoglobin Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hemoglobin Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hemoglobin Above (Month 7)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Hemoglobin Below (Month 7)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Lymphocytes Above (Day 0)	13 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Lymphocytes Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Lymphocytes Above (Month 7)	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Lymphocytes Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Monocytes Above (Day 0)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Monocytes Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Monocytes Above (Month 7)	13 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Monocytes Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Neutrophils Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Neutrophils Below (Day 0)	21 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Neutrophils Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Neutrophils Below (Month 7)	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Platelets Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Platelets Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Platelets Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Platelets Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Red blood cells Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Red blood cells Below (Day 0)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Red blood cells Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Red blood cells Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total protein Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total protein Below (Day 0)	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total protein Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total protein Below (Month 7)	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total bilirubin Above (Day 0)	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total bilirubin Below (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total bilirubin Above (Month 7)	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Total bilirubin Below (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters White blood cells Above (Day 0)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters White blood cells Below (Day 0)	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters White blood cells Above (Month 7)	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters White blood cells Below (Month 7)	5 Participants

Adverse Events

Cervarix Group

Serious events: 0 serious events

Other events: 100 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cervarix Group n=100 participants at risk Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
Infections and infestations Nasopharyngitis	18.0% 18/100
General disorders Injection site pruritus	16.0% 16/100
General disorders Injection site warmth	9.0% 9/100
Gastrointestinal disorders Abdominal pain	6.0% 6/100
Reproductive system and breast disorders Dysmenorrhoea	6.0% 6/100
General disorders Pain	98.0% 98/100
General disorders Redness	85.0% 85/100
General disorders Swelling	81.0% 81/100
General disorders Arthralgia	15.0% 15/100
General disorders Fatigue	40.0% 40/100
General disorders Fever	10.0% 10/100
General disorders Gastrointestinal symptoms	17.0% 17/100
General disorders Headache	33.0% 33/100
General disorders Myalgia	26.0% 26/100

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