A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains. Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization. Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,375
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Adjuvant
Placebo
US135
Hollywood, Florida, United States
US045
Savannah, Georgia, United States
US013
Stockbridge, Georgia, United States
Number of Subjects With Adverse Events (AEs)
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
Time frame: Day 0 - Day 182
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 28
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 28
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182.
Time frame: Day 0 - Day 182
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
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2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
2018-19 Licensed Seasonal Influenza Vaccine
US138
Rockville, Maryland, United States
US025
Norfolk, Nebraska, United States
US018
Omaha, Nebraska, United States
US078
Cary, North Carolina, United States
US108
Raleigh, North Carolina, United States
US137
Salisbury, North Carolina, United States
US132
Statesville, North Carolina, United States
...and 4 more locations
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 182
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio.
Time frame: Day 28 - Day 182
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR.
Time frame: Day 28 - Day 182
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR.
Time frame: Day 28 - Day 182