Trial Outcomes & Findings for Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US (NCT NCT00799825)

Results Overview

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

346 participants

Primary outcome timeframe

Throughout the study (up to Month 12)

Results posted on

2018-07-12

Participant Flow

Subjects in this study come from the primary study (NCT00122681) where they were included in the control group and received Hepatitis A vaccination. The number of subjects that started the study included only those subjects with the vaccine dose administered.

Participant milestones

Participant milestones
Measure	Cervarix Group Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Overall Study STARTED	344
Overall Study COMPLETED	296
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix Group Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	38
Overall Study Pregnancy	3

Baseline Characteristics

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix Group n=344 Participants Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Age, Continuous	25.4 Years STANDARD_DEVIATION 2.81 • n=5 Participants
Sex: Female, Male Female	344 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout the study (up to Month 12)

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Cervarix Group n=344 Participants Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Any SAEs	8 Subjects
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Grade 3 SAEs	5 Subjects
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects

PRIMARY outcome

Timeframe: Throughout the study (up to Month 12)

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs 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. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Cervarix Group n=344 Participants Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) Any MSCs	32 Subjects
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) Grade 3 MSCs	9 Subjects
Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) Related MSCs	0 Subjects

PRIMARY outcome

Timeframe: Throughout the study (up to Month 12)

Population: The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

Outcome measures

Outcome measures
Measure	Cervarix Group n=19 Participants Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Number of Subjects With Pregnancies and Pregnancy Outcomes. Live infant NO apparent congenital anomaly	14 Subjects
Number of Subjects With Pregnancies and Pregnancy Outcomes. Lost to follow up	1 Subjects
Number of Subjects With Pregnancies and Pregnancy Outcomes. Elective termination NO apparent congenital anom.	2 Subjects
Number of Subjects With Pregnancies and Pregnancy Outcomes. Spontaneous abortion NO apparent congenital anom.	2 Subjects

Adverse Events

Cervarix Group

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cervarix Group n=344 participants at risk Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous complete	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Pregnancy, puerperium and perinatal conditions Blighted ovum	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Hepatobiliary disorders Cholecystitis	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Hepatobiliary disorders Cholecystitis acute	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Metabolism and nutrition disorders Dehydration	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Congenital, familial and genetic disorders Dermoid cyst	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Psychiatric disorders Obsessive-compulsive disorder	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.
Blood and lymphatic system disorders Thrombocytopenia	0.29% 1/344 • SAEs were reported throughout the study period, from Day 0 up to Month 12. No other adverse events were reported.

Other adverse events

Adverse event data not reported

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