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Trial Outcomes & Findings for Immune Response Following Seasonal Influenza Vaccination (NCT NCT03163342)

NCT ID: NCT03163342

Last Updated: 2019-04-26

Results Overview

To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Day 29 after vaccine

Results posted on

2019-04-26

Participant Flow

Participant milestones

Participant milestones
Measure
Open Label
Licensed seasonal influenza vaccine, intramuscular Licensed seasonal influenza vaccine: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Response Following Seasonal Influenza Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Open Label
n=20 Participants
Licensed seasonal influenza vaccine, intramuscular Licensed seasonal influenza vaccine: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Age, Continuous
34.2 years
n=93 Participants
Sex: Female, Male
Female
10 Participants
n=93 Participants
Sex: Female, Male
Male
10 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=93 Participants
Race (NIH/OMB)
White
9 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Day 29 after vaccine

To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.

Outcome measures

Outcome measures
Measure
FluZone
n=20 Participants
Open label
HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain
293.4 Geometric Mean Titer
Interval 186.7 to 461.3

SECONDARY outcome

Timeframe: Day 29 after vaccine

l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine

Outcome measures

Outcome measures
Measure
FluZone
n=20 Participants
Open label
Antibody Response to Divergent Influenza Strains
A/Brisbane/59/2007 (H1 strain)
12.3 GMT
Interval 6.9 to 21.8
Antibody Response to Divergent Influenza Strains
A/New Jersey/76 (H1 strain)
37.3 GMT
Interval 22.5 to 61.9
Antibody Response to Divergent Influenza Strains
A/Saint-Petersburg/61/2015 (H1 strain)
40.7 GMT
Interval 21.8 to 76.1
Antibody Response to Divergent Influenza Strains
A/Vietnam/1203/2004XPR8 (H5 strain)
9.3 GMT
Interval 6.0 to 14.6

SECONDARY outcome

Timeframe: Day 8 after vaccine

To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine

Outcome measures

Outcome measures
Measure
FluZone
n=20 Participants
Open label
Cellular Immune Response
37.1 GMT
Interval 14.3 to 96.2

SECONDARY outcome

Timeframe: Day 29 after vaccine

To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine

Outcome measures

Outcome measures
Measure
FluZone
n=20 Participants
Open label
Mucosal Influenza Antibody Response
1.8 GMT
Interval 1.2 to 2.7

Adverse Events

FluZone

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

Stephanie Holland, Clinical Project Manager

Altimmune

Phone: 240

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place