Trial Outcomes & Findings for Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM (NCT NCT01160237)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

21 days after vaccination

Results posted on

2016-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Pandemrix Group Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pandemrix Group n=4 Participants Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group n=3 Participants Subjects previously vaccinated with Pandemrix received one dose of Fluarix.	Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.	Total n=7 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 9.50 • n=5 Participants	55.3 years STANDARD_DEVIATION 18.80 • n=7 Participants	—	58.7 years STANDARD_DEVIATION 13.16 • n=4 Participants
Gender Female	3 subjects n=5 Participants	2 subjects n=7 Participants	—	5 subjects n=4 Participants
Gender Male	1 subjects n=5 Participants	1 subjects n=7 Participants	—	2 subjects n=4 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 7 days (Day 0 - Day 6) after vaccination

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During 31 days (Day 0 - Day 30) after vaccination

Population: The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.

Outcome measures

Outcome measures
Measure	Pandemrix Group n=4 Participants Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group n=3 Participants Subjects previously vaccinated with Pandemrix received one dose of Fluarix.	Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Number of Subjects Reporting Unsolicited Adverse Events	0 subjects	2 subjects	—

SECONDARY outcome

Timeframe: During the whole study period (Day 0 - Day 182)

Population: The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.

Outcome measures

Outcome measures
Measure	Pandemrix Group n=4 Participants Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group n=3 Participants Subjects previously vaccinated with Pandemrix received one dose of Fluarix.	Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Number of Subjects Reporting Serious Adverse Events	1 subjects	0 subjects	—

SECONDARY outcome

Timeframe: During the whole study period (Day 0 - Day 182)

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Days 0, 7 and 182

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Outcome measures

Outcome data not reported

Adverse Events

Pandemrix Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pandemrix Group n=4 participants at risk Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group n=3 participants at risk Subjects previously vaccinated with Pandemrix received one dose of Fluarix.	Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Injury, poisoning and procedural complications femoral neck fracture	25.0% 1/4	0.00% 0/3	— 0/0

Other adverse events

Other adverse events
Measure	Pandemrix Group n=4 participants at risk Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.	Fluarix Group n=3 participants at risk Subjects previously vaccinated with Pandemrix received one dose of Fluarix.	Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Infections and infestations Upper respiratory tract infection	0.00% 0/4	33.3% 1/3	— 0/0
Cardiac disorders Hypertension	0.00% 0/4	33.3% 1/3	— 0/0

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