Trial Outcomes & Findings for Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting (NCT NCT01654224)

Last Updated: 2017-07-02

Results Overview

The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

205 participants

Primary outcome timeframe

30 days

Results posted on

2017-07-02

Participant Flow

Participants were enrolled during the 2011-2012 and 2012-2013 influenza seasons

A total of 205 participants from 15 community-based LTCFs who met all inclusion and none of the exclusion criteria were enrolled.

Participant milestones

Participant milestones
Measure	HD IIV Frail adults 65 years or older who received Fluzone High Dose intramuscularly.	SD IIV Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
Overall Study STARTED	95	110
Overall Study COMPLETED	89	98
Overall Study NOT COMPLETED	6	12

Reasons for withdrawal

Reasons for withdrawal
Measure	HD IIV Frail adults 65 years or older who received Fluzone High Dose intramuscularly.	SD IIV Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
Overall Study Lost to Follow-up	2	2
Overall Study Did not receive allocation	1	8
Overall Study Insufficient blood sample	3	2

Baseline Characteristics

Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HD IIV n=89 Participants Frail adults 65 years and older who received Fluzone High Dose intramuscularly	SD IIV n=98 Participants Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly	Total n=187 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	89 Participants n=5 Participants	98 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	71 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=5 Participants	96 Participants n=7 Participants	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	89 Participants n=5 Participants	96 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	98 participants n=7 Participants	187 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	High Dose Inactivated Influenza Vaccine n=89 Participants For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin	Standard Dose Inactivated Influenza Vaccine n=98 Participants For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/California/07/2009(H1N1)-2011-2012 Season	78.2 titers Interval 45.1 to 135.7	27.4 titers Interval 17.0 to 44.3
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/Victoria/210/2009(H3N2	26.2 titers Interval 17.1 to 40.0	10.2 titers Interval 7.0 to 14.8
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings B/Brisbane/60/2008	25.6 titers Interval 18.7 to 34.9	14.3 titers Interval 11.1 to 18.4
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/California/07/2009(H1N1)- 2012-2013 Season	45.6 titers Interval 32.9 to 63.2	50.0 titers Interval 37.4 to 67.0
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/Victoria/361/2011(H3N2)	23.4 titers Interval 17.6 to 31.0	14.2 titers Interval 11.0 to 18.4
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings B/Texas/6/2011	26.0 titers Interval 21.2 to 31.9	17.4 titers Interval 13.9 to 21.9

PRIMARY outcome

Timeframe: Day 0

Outcome measures

Outcome measures
Measure	High Dose Inactivated Influenza Vaccine n=89 Participants For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin	Standard Dose Inactivated Influenza Vaccine n=98 Participants For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/California/07/2009(H1N1)2011-2012 Season	17.1 titers Interval 11.3 to 25.9	16.6 titers Interval 10.3 to 26.7
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/Victoria/210/2009(H3N2	8.9 titers Interval 6.5 to 12.3	7.3 titers Interval 5.3 to 10.0
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings B/Brisbane/60/2008	15.3 titers Interval 10.3 to 22.6	11.6 titers Interval 8.6 to 15.5
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/California/07/2009(H1N1) 2012-2013 Season	23.6 titers Interval 16.7 to 33.4	32.3 titers Interval 23.8 to 43.9
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings A/Victoria/361/2011(H3N2)	7.2 titers Interval 6.1 to 8.3	6.2 titers Interval 5.4 to 7.1
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings B/Texas/6/2011	7.9 titers Interval 6.5 to 9.5	9.1 titers Interval 7.5 to 11.0

SECONDARY outcome

Timeframe: 6 months

Population: The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected.

Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents

Outcome measures

Outcome measures
Measure	High Dose Inactivated Influenza Vaccine n=79 Participants For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin	Standard Dose Inactivated Influenza Vaccine n=83 Participants For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
Non-inferiority and Immunoprotection Persistence at 6 Months A/California/07/2009(H1N1) 2011-2012 Season	59.7 Titers Interval 33.5 to 106.3	28.3 Titers Interval 15.3 to 52.4
Non-inferiority and Immunoprotection Persistence at 6 Months A/Victoria/210/2009(H3N2)	22.3 Titers Interval 14.5 to 34.3	9.4 Titers Interval 6.0 to 14.8
Non-inferiority and Immunoprotection Persistence at 6 Months B/Brisbane/60/2008	22.9 Titers Interval 16.3 to 32.0	15.4 Titers Interval 11.8 to 20.2
Non-inferiority and Immunoprotection Persistence at 6 Months A/California/07/2009(H1N1) @012-2013 Season	46.8 Titers Interval 33.2 to 65.9	51.8 Titers Interval 37.8 to 71.1
Non-inferiority and Immunoprotection Persistence at 6 Months A/Victoria/361/2011(H3N2)	24.7 Titers Interval 18.3 to 33.2	13.4 Titers Interval 10.3 to 17.5
Non-inferiority and Immunoprotection Persistence at 6 Months B/Texas/6/2011	25.3 Titers Interval 20.8 to 30.9	18.9 Titers Interval 14.9 to 23.9

Adverse Events

HD IIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SD IIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Nace, MD, MPH

University of Pittsburgh

Phone: 412 692-2366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place