Trial Outcomes & Findings for Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age. (NCT NCT00750360)

NCT ID: NCT00750360

Last Updated: 2018-11-06

Results Overview

An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 883 participants
• Primary outcome timeframe: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
• Results posted on: 2018-11-06

Participant Flow

Participant milestones

Measure	Unprimed, > 6 to < 72 Months Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Overall Study STARTED	294	1	384	79	46	71
Overall Study COMPLETED	294	1	384	79	46	71
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

Baseline characteristics by cohort

Measure	Unprimed, > 6 to < 72 Months n=294 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 Participants Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 Participants Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 Participants Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 Participants Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).	Total n=875 Participants Total of all reporting groups
Age, Continuous	13.7 months STANDARD_DEVIATION 10.60 • n=5 Participants	85.0 months STANDARD_DEVIATION 0 • n=7 Participants	38.3 months STANDARD_DEVIATION 18.80 • n=5 Participants	86.4 months STANDARD_DEVIATION 10.60 • n=4 Participants	132.7 months STANDARD_DEVIATION 22.00 • n=21 Participants	454.5 months STANDARD_DEVIATION 174.40 • n=10 Participants	73.2 months STANDARD_DEVIATION 128.07 • n=115 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	1 Participants n=7 Participants	178 Participants n=5 Participants	41 Participants n=4 Participants	27 Participants n=21 Participants	56 Participants n=10 Participants	445 Participants n=115 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	0 Participants n=7 Participants	206 Participants n=5 Participants	38 Participants n=4 Participants	19 Participants n=21 Participants	15 Participants n=10 Participants	430 Participants n=115 Participants

PRIMARY outcome

Timeframe: During the 21-day follow-up period (Day 0 to Day 20) after vaccination

An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities

Outcome measures

Measure	Unprimed, > 6 to < 72 Months n=294 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 Participants Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 Participants Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 Participants Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 Participants Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Number of Participants Reporting Severe Unsolicited Adverse Events	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: During the 4-day follow up (Day 0 to 3) after vaccination.

Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.

Outcome measures

Measure	Unprimed, > 6 to < 72 Months n=294 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=384 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Induration	3 participants	22 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Pain	3 participants	58 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Redness	3 participants	40 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Swelling	2 participants	36 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Fever	7 participants	9 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Shivering	0 participants	3 participants	—	—	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. Sweating/diaphoresis	1 participants	2 participants	—	—	—	—

SECONDARY outcome

Timeframe: During the 4-day follow up (Day 0 to 3) after vaccination.

Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.

Outcome measures

Measure	Unprimed, > 6 to < 72 Months n=1 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=79 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=46 Participants Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=71 Participants Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Pain	0 participants	23 participants	7 participants	10 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Redness	0 participants	11 participants	7 participants	4 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Swelling	0 participants	10 participants	6 participants	4 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Myalgia	0 participants	6 participants	3 participants	5 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Induration	0 participants	8 participants	5 participants	4 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Fatigue	0 participants	3 participants	3 participants	2 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Fever	0 participants	2 participants	1 participants	0 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Headache	0 participants	4 participants	2 participants	1 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Malaise	0 participants	1 participants	1 participants	1 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Shivering	0 participants	0 participants	0 participants	2 participants	—	—
Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. Sweating/diaphoresis	0 participants	0 participants	0 participants	2 participants	—	—

SECONDARY outcome

Timeframe: During the 21-day follow-up period (Day 0 to Day 20) after vaccination

An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	Unprimed, > 6 to < 72 Months n=294 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 Participants Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 Participants Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 Participants Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 Participants Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Number of Participant Reporting Unsolicited Adverse Events.	28 participants	0 participants	67 participants	12 participants	6 participants	3 participants

SECONDARY outcome

Timeframe: Within 1 month following vaccination

An SAE is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Measure	Unprimed, > 6 to < 72 Months n=294 Participants Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 Participants Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 Participants Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 Participants Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 Participants Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 Participants Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Number of Participants Reporting Serious Adverse Events (SAE).	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants

Adverse Events

Unprimed, > 6 to < 72 Months

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Unprimed, ≥ 72 to < 108 Months

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Primed, > 6 to < 72 Months

Serious events: 0 serious events

Other events: 90 other events

Deaths: 0 deaths

Primed, ≥ 72 to < 108 Months

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Primed, ≥ 108 to < 216 Months

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Primed, ≥ 216 Months

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Unprimed, > 6 to < 72 Months n=294 participants at risk Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 participants at risk Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 participants at risk Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 participants at risk Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 participants at risk Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 participants at risk Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
Infections and infestations Kawasaki's disease	0.34% 1/294	0.00% 0/1	0.00% 0/384	0.00% 0/79	0.00% 0/46	0.00% 0/71

Other adverse events

Measure	Unprimed, > 6 to < 72 Months n=294 participants at risk Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).	Unprimed, ≥ 72 to < 108 Months n=1 participants at risk Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).	Primed, > 6 to < 72 Months n=384 participants at risk Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).	Primed, ≥ 72 to < 108 Months n=79 participants at risk Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).	Primed, ≥ 108 to < 216 Months n=46 participants at risk Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).	Primed, ≥ 216 Months n=71 participants at risk Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
General disorders Pain	1.0% 3/294	0.00% 0/1	15.1% 58/384	29.1% 23/79	15.2% 7/46	14.1% 10/71
Skin and subcutaneous tissue disorders Erythema	1.0% 3/294	0.00% 0/1	10.4% 40/384	13.9% 11/79	15.2% 7/46	5.6% 4/71
General disorders Swelling	0.68% 2/294	0.00% 0/1	9.4% 36/384	12.7% 10/79	13.0% 6/46	5.6% 4/71
General disorders Induration	1.0% 3/294	0.00% 0/1	5.7% 22/384	10.1% 8/79	10.9% 5/46	5.6% 4/71
General disorders Fatigue	0.00% 0/294	0.00% 0/1	0.26% 1/384	3.8% 3/79	6.5% 3/46	2.8% 2/71
Nervous system disorders Headache	0.00% 0/294	0.00% 0/1	0.26% 1/384	5.1% 4/79	4.3% 2/46	1.4% 1/71
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/294	0.00% 0/1	0.26% 1/384	7.6% 6/79	6.5% 3/46	7.0% 5/71

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