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Trial Outcomes & Findings for Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP (NCT NCT03722589)

NCT ID: NCT03722589

Last Updated: 2024-07-22

Results Overview

MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

944 participants

Primary outcome timeframe

28 days post-vaccination during year 1

Results posted on

2024-07-22

Participant Flow

During year 1, participants were randomized to 1 of 4 vaccine assignments as shown. During year 2, some participants from year 1 were retained (n=546) and additional participants (n=217) were enrolled. During year 2, retained participants from year 1 were rerandomized to vaccine groups. Participants completed consent at year 1 start and again at year 2 start, so the number of enrolled participants at year 2 start is not the cumulative sum of participants enrolled at year 1 and year 2 start.

Participant milestones

Participant milestones
Measure
Flublok (Recombinant)
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok: 0.5 mL intramuscular dose of Flublok
Flucelvax (Cell-based)
Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain Flucelvax: 0.5 mL intramuscular dose of Flucelvax
Fluarix (Egg-based)
Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain Fluarix: 0.5 mL intramuscular dose of Fluarix
Fluzone (Egg-based)
Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain Fluzone: 0.5 mL intramuscular dose of Fluzone
Fluzone (Egg-based) High-Dose
Fluzone® Trivalent High-Dose by Sanofi Pasteur, 60µg of HA per strain Fluzone High-Dose: 0.5 mL intramuscular dose of Fluzone
Year 1 (2018-19)
STARTED
202
283
120
122
0
Year 1 (2018-19)
COMPLETED
195
279
97
86
0
Year 1 (2018-19)
NOT COMPLETED
7
4
23
36
0
Year 2 (2019-20)
STARTED
292
287
0
105
79
Year 2 (2019-20)
COMPLETED
285
281
0
103
79
Year 2 (2019-20)
NOT COMPLETED
7
6
0
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Flublok (Recombinant)
n=202 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok: 0.5 mL intramuscular dose of Flublok
Flucelvax (Cell-based)
n=283 Participants
Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain Flucelvax: 0.5 mL intramuscular dose of Flucelvax
Fluarix (Egg-based)
n=120 Participants
Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain Fluarix: 0.5 mL intramuscular dose of Fluarix
Fluzone (Egg-based)
n=122 Participants
Fluzone® Quadrivalent by Sanofi Pasteur, 15µg of HA per strain Fluzone: 0.5 mL intramuscular dose of Fluzone
Fluzone High Dose - Year 2
n=79 Participants
Fluzone High Dose by Sanofi Pasteur, 45µg of HA per strain Fluzone High Dose: 0.5 mL intramuscular dose of Fluzone
Total
n=806 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
202 Participants
n=5 Participants
283 Participants
n=7 Participants
120 Participants
n=5 Participants
122 Participants
n=4 Participants
79 Participants
n=21 Participants
806 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
157 Participants
n=5 Participants
232 Participants
n=7 Participants
103 Participants
n=5 Participants
107 Participants
n=4 Participants
53 Participants
n=21 Participants
652 Participants
n=10 Participants
Sex: Female, Male
Male
45 Participants
n=5 Participants
51 Participants
n=7 Participants
17 Participants
n=5 Participants
15 Participants
n=4 Participants
26 Participants
n=21 Participants
154 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants
n=5 Participants
37 Participants
n=7 Participants
19 Participants
n=5 Participants
13 Participants
n=4 Participants
4 Participants
n=21 Participants
110 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
165 Participants
n=5 Participants
246 Participants
n=7 Participants
101 Participants
n=5 Participants
109 Participants
n=4 Participants
75 Participants
n=21 Participants
696 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
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
Region of Enrollment
United States
202 participants
n=5 Participants
283 participants
n=7 Participants
120 participants
n=5 Participants
122 participants
n=4 Participants
79 participants
n=21 Participants
806 participants
n=10 Participants

PRIMARY outcome

Timeframe: 28 days post-vaccination during year 1

Population: For the primary analysis, the Fluarix and Fluzone arms were combined as prespecified in the study protocol.

MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40

Outcome measures

Outcome measures
Measure
Flublok (Recombinant)
n=202 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok: 0.5 mL intramuscular dose of Flublok
Flucelvax (Cell-based)
n=283 Participants
Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain Flucelvax: 0.5 mL intramuscular dose of Flucelvax
Fluarix (Egg-based)/Fluzone (Egg-based)
n=242 Participants
Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain Fluarix: 0.5 mL intramuscular dose of Fluarix
Fluzone High Dose
Fluzone® High Dose by Sanofi Pasteur, 45µg of HA per strain Fluzone High Dose: 0.5 mL intramuscular dose of Fluzone
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
112 Participants
48 Participants
29 Participants
—

PRIMARY outcome

Timeframe: 28 days post-vaccination during year 2

Population: For the primary analysis, the Fluarix and Fluzone arms were combined as prespecified in the study protocol.

MN responses to the cell-grown influenza A/H3N2 vaccine reference viruses for each study season at approximately 28 days post-vaccination, including by assessing SCR in the various vaccine arms defined as the proportion of participants with paired samples that achieved ≥ 4 fold rises comparing post- versus pre-vaccination titers, and post vaccination titers ≥ 40

Outcome measures

Outcome measures
Measure
Flublok (Recombinant)
n=103 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok: 0.5 mL intramuscular dose of Flublok
Flucelvax (Cell-based)
n=106 Participants
Flucelvax™ Quadrivalent by Seqirus, Inc., 15µg of HA per strain Flucelvax: 0.5 mL intramuscular dose of Flucelvax
Fluarix (Egg-based)/Fluzone (Egg-based)
n=102 Participants
Fluarix® Quadrivalent by GlaxoSmithKlein, 15µg of HA per strain Fluarix: 0.5 mL intramuscular dose of Fluarix
Fluzone High Dose
n=79 Participants
Fluzone® High Dose by Sanofi Pasteur, 45µg of HA per strain Fluzone High Dose: 0.5 mL intramuscular dose of Fluzone
Microneutralization (MN) Assay Response to Cell-grown Influenza A/H3N2 - Seroconversion Rate (SCR)
103 Participants
106 Participants
102 Participants
79 Participants

Adverse Events

Flublok (Recombinant)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Flucelvax (Cell-based)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fluarix (Egg-based)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fluzone (Egg-based)

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

Fatimah Dawood, Medical Officer

Centers for Disease Control and Prevention

Phone: 404-639-0431

Results disclosure agreements

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