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Trial Outcomes & Findings for Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel (NCT NCT04523324)

NCT ID: NCT04523324

Last Updated: 2023-11-15

Results Overview

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

577 participants

Primary outcome timeframe

Day 28 days after vaccination

Results posted on

2023-11-15

Participant Flow

577 HCP were randomly allocated to receive either IIV4 or RIV4. Due to a delay in the delivery of RIV4 vaccines, 67 participants randomized to receive RIV4 had already been vaccinated in the community with IIV4 before the study started. Because they received the same IIV4 brand (Vaxigrip) as the study control vaccine, we allowed them to continue in the study as controls.

Participant milestones

Participant milestones
Measure
RIV4 (Flublok Quadrivalent)
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Overall Study
STARTED
211
366
Overall Study
COMPLETED
203
334
Overall Study
NOT COMPLETED
8
32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Total
n=537 Participants
Total of all reporting groups
Age, Continuous
47 years
n=5 Participants
44 years
n=7 Participants
45 years
n=5 Participants
Sex: Female, Male
Female
133 Participants
n=5 Participants
229 Participants
n=7 Participants
362 Participants
n=5 Participants
Sex: Female, Male
Male
70 Participants
n=5 Participants
105 Participants
n=7 Participants
175 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Arab
16 Participants
n=5 Participants
22 Participants
n=7 Participants
38 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Jewish, not Ultra-Orthodox
181 Participants
n=5 Participants
305 Participants
n=7 Participants
486 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Jewish, Ultra-Orthodox
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
Region of Enrollment
Israel
203 participants
n=5 Participants
334 participants
n=7 Participants
537 participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 28 days after vaccination

Population: Influenza A(H1N1)pdm09 Hemagglutination Inhibition Assay Outcome

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1
173.1 titers
Interval 148.5 to 201.7
83.9 titers
Interval 74.5 to 94.5

PRIMARY outcome

Timeframe: 0 to 28 days after vaccination

Population: Influenza A(H1N1)pdm09 Hemagglutination Inhibition Assay Outcome

The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4.

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1
4.0 Mean-Fold Change
Interval 3.2 to 5.0
1.9 Mean-Fold Change
Interval 1.6 to 2.2

PRIMARY outcome

Timeframe: Day 28 days after vaccination

Population: Egg-grown influenza A(H3N2) Hemagglutination Inhibition Assay Outcome

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2
241.9 titers
Interval 211.1 to 277.0
175.7 titers
Interval 158.0 to 195.3

PRIMARY outcome

Timeframe: 0 to 28 days after vaccination

Population: egg-grown influenza virus A/H3N2 Hemagglutination Inhibition Assay Outcome

The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2
4.1 Mean-Fold Change
Interval 3.4 to 5.0
2.4 Mean-Fold Change
Interval 2.1 to 2.8

PRIMARY outcome

Timeframe: Day 28 days after vaccination

Population: Cell-grown influenza A(H3N2) Hemagglutination Inhibition Assay Outcome

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2
185.3 Titers
Interval 163.4 to 210.1
86.7 Titers
Interval 78.7 to 95.7

PRIMARY outcome

Timeframe: 0 to 28 days after vaccination

Population: Cell-grown influenza virus A/H3N2 Hemagglutination Inhibition Assay Outcome

The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4.

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2
6.1 Mean-Fold Change
Interval 5.1 to 7.3
2.6 Mean-Fold Change
Interval 2.3 to 3.0

PRIMARY outcome

Timeframe: Day 28 days after vaccination

Population: Influenza B(Victoria) Hemagglutination Inhibition Assay Outcome

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria)

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Post-vaccination Geometric Mean Titer Against Influenza B(Victoria)
89.5 titers
Interval 77.7 to 103.2
76.0 titers
Interval 68.0 to 84.8

PRIMARY outcome

Timeframe: 0 to 28 days after vaccination

Population: Influenza B(Victoria) Hemagglutination Inhibition Assay Outcome

The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4.

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria)
1.9 Mean-Fold Change
Interval 1.5 to 2.3
1.5 Mean-Fold Change
Interval 1.3 to 1.7

PRIMARY outcome

Timeframe: Day 28 days after vaccination

Population: Influenza B(Yamagata) Hemagglutination Inhibition Assay Outcome

The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata)

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata)
191.1 titers
Interval 165.4 to 220.8
108.3 titers
Interval 96.8 to 121.2

PRIMARY outcome

Timeframe: 0 to 28 days after vaccination

Population: Influenza virus B(Yamagata) Hemagglutination Inhibition Assay Outcome

The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4.

Outcome measures

Outcome measures
Measure
RIV4 (Flublok Quadrivalent)
n=203 Participants
Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok
IIV4 (Vaxigrip Quadrivalent)
n=334 Participants
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata)
2.7 Mean-Fold Change
Interval 2.2 to 3.4
1.5 Mean-Fold Change
Interval 1.3 to 1.8

Adverse Events

RIV4 (Flublok Quadrivalent)

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

IIV4 (Vaxigrip Quadrivalent)

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

Dr. Ashley Fowlkes

Centers for Disease Control and Prevention

Phone: 4046394830

Results disclosure agreements

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