Trial Outcomes & Findings for Immune Responses Induced by Different Licensed Influenza Vaccines (NCT NCT00902278)

NCT ID: NCT00902278

Last Updated: 2017-11-20

Results Overview

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Recruitment status

COMPLETED

Study phase

Target enrollment

193 participants

Primary outcome timeframe

Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Results posted on

2017-11-20

Participant Flow

We recruited healthy adults subjects during the 2008-2009, 2009-2010, 2010-2011, and 2011-2012 influenza seasons in a clinical research setting.

Participant milestones

Participant milestones
Measure	Flulaval Flulaval: one 0.5-mL dose via intramuscular injection	Fluvirin Fluvirin: one 0.5-mL dose via intramuscular injection	Fluzone Fluzone: one 0.5-mL dose via intramuscular injection	Fluarix Fluarix: one 0.5-mL dose via intramuscular injection	Afluria Afluria: one 0.5-mL dose via intramuscular injection
Overall Study STARTED	54	36	54	12	37
Overall Study COMPLETED	50	34	49	12	35
Overall Study NOT COMPLETED	4	2	5	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Flulaval Flulaval: one 0.5-mL dose via intramuscular injection	Fluvirin Fluvirin: one 0.5-mL dose via intramuscular injection	Fluzone Fluzone: one 0.5-mL dose via intramuscular injection	Fluarix Fluarix: one 0.5-mL dose via intramuscular injection	Afluria Afluria: one 0.5-mL dose via intramuscular injection
Overall Study Physician Decision	1	0	2	0	1
Overall Study Lost to Follow-up	3	2	3	0	1

Baseline Characteristics

Immune Responses Induced by Different Licensed Influenza Vaccines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flulaval n=54 Participants Flulaval: one 0.5-mL dose via intramuscular injection	Fluvirin n=36 Participants Fluvirin: one 0.5-mL dose via intramuscular injection	Fluzone n=54 Participants Fluzone: one 0.5-mL dose via intramuscular injection	Fluarix n=12 Participants Fluarix: one 0.5-mL dose via intramuscular injection	Afluria n=37 Participants Afluria: one 0.5-mL dose via intramuscular injection	Total n=193 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	36 Participants n=7 Participants	54 Participants n=5 Participants	12 Participants n=4 Participants	37 Participants n=21 Participants	193 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants	141 Participants n=10 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants	52 Participants n=10 Participants
Region of Enrollment United States	54 participants n=5 Participants	36 participants n=7 Participants	54 participants n=5 Participants	12 participants n=4 Participants	37 participants n=21 Participants	193 participants n=10 Participants

PRIMARY outcome

Timeframe: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Population: Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for Flulaval group.Only participants with evaluable data were included in the analysis.

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Outcome measures

Outcome measures
Measure	Flulaval Flulaval: one 0.5-mL dose via intramuscular injection	Fluvirin n=10 Participants Fluvirin: one 0.5-mL dose via intramuscular injection	Fluzone n=12 Participants Fluzone: one 0.5-mL dose via intramuscular injection	Fluarix n=11 Participants Fluarix: one 0.5-mL dose via intramuscular injection	Afluria n=12 Participants Afluria: one 0.5-mL dose via intramuscular injection
T Cell Responses Following Immunization H1N1 virus	—	1.5 fold change Standard Deviation .55	1.7 fold change Standard Deviation .84	1.9 fold change Standard Deviation .56	1.6 fold change Standard Deviation .71
T Cell Responses Following Immunization H3N2 virus	—	2.4 fold change Standard Deviation 1.28	2.1 fold change Standard Deviation 1.34	2.7 fold change Standard Deviation 1.23	1.7 fold change Standard Deviation .60
T Cell Responses Following Immunization B virus	—	1.5 fold change Standard Deviation .61	1.6 fold change Standard Deviation .59	1.6 fold change Standard Deviation .59	1.4 fold change Standard Deviation .61

SECONDARY outcome

Timeframe: Prevaccination and approximately 1 month post vaccination

Population: Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for the flulaval group. Only participants with evaluable data were included in this analysis.

Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group