Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age (NCT NCT02545543)
NCT ID: NCT02545543
Last Updated: 2018-05-23
Results Overview
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2278 participants
Primary outcome timeframe
28 days after last vaccination.
Results posted on
2018-05-23
Participant Flow
First Patient In: 14-SEP-2015, Last Patient Last Visit: 13-JUN-2016. Number of activated sites that enrolled subjects: 32 (all based in USA).
Number of subjects screened: 2349. Number of subjects randomized: 2278
Participant milestones
| Measure |
Seqirus Quadrivalent Influenza Vaccine
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
1709
|
569
|
|
Overall Study
COMPLETED
|
1628
|
535
|
|
Overall Study
NOT COMPLETED
|
81
|
34
|
Reasons for withdrawal
| Measure |
Seqirus Quadrivalent Influenza Vaccine
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
67
|
25
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Noncomplaince
|
1
|
0
|
|
Overall Study
Enrolment of subject at >1 study site
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
Baseline characteristics by cohort
| Measure |
Seqirus Quadrivalent Influenza Vaccine
n=1709 Participants
The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Comparator Quadrivalent Influenza Vaccine
n=569 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Total
n=2278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.5 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
9.5 years
STANDARD_DEVIATION 3.46 • n=7 Participants
|
9.5 years
STANDARD_DEVIATION 3.48 • n=5 Participants
|
|
Age, Customized
5 through 8 years
|
875 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
1166 Participants
n=5 Participants
|
|
Age, Customized
9 through 17 years
|
834 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
1112 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
825 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
1092 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
884 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
1186 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
412 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1293 Participants
n=5 Participants
|
438 Participants
n=7 Participants
|
1731 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
359 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1239 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
1669 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1709 participants
n=5 Participants
|
569 participants
n=7 Participants
|
2278 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after last vaccination.Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.
Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=2133 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
A/H1N1
|
1.01 Ratio
Interval 0.93 to 1.09
|
—
|
|
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
A/H3N2
|
1.05 Ratio
Interval 0.96 to 1.15
|
—
|
|
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
B/Yamagata
|
0.89 Ratio
Interval 0.81 to 0.98
|
—
|
|
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
B/Victoria
|
0.92 Ratio
Interval 0.83 to 1.02
|
—
|
PRIMARY outcome
Timeframe: 28 days after last vaccination.Population: The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.
Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=2133 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
A/H1N1
|
-3.1 percentage of participants
Interval -8.0 to 1.8
|
—
|
|
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
A/H3N2
|
0.4 percentage of participants
Interval -4.5 to 5.3
|
—
|
|
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
B/Yamagata
|
-3.4 percentage of participants
Interval -8.3 to 1.5
|
—
|
|
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
B/Victoria
|
-2.0 percentage of participants
Interval -6.9 to 2.9
|
—
|
SECONDARY outcome
Timeframe: 7 days after each vaccination.Population: The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.
Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1621 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=535 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
Frequency of Solicited Local AEs
|
909 participants
|
279 participants
|
|
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
Severe (Grade 3) Solicited Local AEs
|
71 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 7 days after each vaccination.Population: The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.
Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1621 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=535 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
Frequency of Solicited Systemic AEs
|
499 participants
|
147 participants
|
|
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
Severe (Grade 3) Solicited Systemic AEs
|
24 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 28 days after each vaccination.Population: The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.
Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1621 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=535 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 28 days after each vaccination.Population: The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data.
Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1692 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=560 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
At least one Unsolicited AE
|
269 participants
|
70 participants
|
|
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
Severe (Grade 3) Unsolicited AE
|
11 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 180 days after the last vaccination dose.Population: The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data
Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1692 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=560 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 28 days after last vaccination.Population: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results
The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- Geometric mean of HI titers prevaccination \& postvaccination
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1605 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=528 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
A/H1N1 (pre-vaccination)
|
114.8 Titer
Interval 106.79 to 123.33
|
119.5 Titer
Interval 105.48 to 135.38
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
A/H3N2 (pre-vaccination)
|
75.2 Titer
Interval 70.8 to 79.88
|
72.1 Titer
Interval 64.61 to 80.4
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
B/Yamagata (pre-vaccination)
|
10.5 Titer
Interval 10.12 to 10.99
|
10.4 Titer
Interval 9.69 to 11.22
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
B/Victoria (pre-vaccination)
|
17.0 Titer
Interval 16.1 to 17.85
|
16.9 Titer
Interval 15.42 to 18.46
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
A/H1N1 (post-vaccination)
|
858.7 Titer
Interval 821.46 to 897.65
|
875.1 Titer
Interval 814.14 to 940.59
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
A/H3N2 (post-vaccination)
|
803.6 Titer
Interval 763.01 to 846.26
|
825.6 Titer
Interval 756.12 to 901.55
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
B/Yamagata (post-vaccination)
|
60.7 Titer
Interval 57.52 to 64.01
|
54.3 Titer
Interval 49.65 to 59.28
|
|
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
B/Victoria (post-vaccination)
|
140.9 Titer
Interval 132.97 to 149.26
|
130.3 Titer
Interval 117.07 to 145.06
|
SECONDARY outcome
Timeframe: 28 days after last vaccination.Population: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.
The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- SCRs: % of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1605 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=528 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR)
A/H1N1
|
66.4 percentage of participants
Interval 64.0 to 68.7
|
63.3 percentage of participants
Interval 59.0 to 67.4
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR)
A/H3N2
|
82.9 percentage of participants
Interval 81.0 to 84.7
|
83.3 percentage of participants
Interval 79.9 to 86.4
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR)
B/Yamagata
|
58.5 percentage of participants
Interval 56.0 to 60.9
|
55.1 percentage of participants
Interval 50.8 to 59.4
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR)
B/Victoria
|
72.1 percentage of participants
Interval 69.8 to 74.3
|
70.1 percentage of participants
Interval 66.0 to 74.0
|
SECONDARY outcome
Timeframe: 28 days after last vaccination.Population: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results
The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1605 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=528 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Immunogenicity Endpoint: Seroprotection Rate
A/H1N1 (pre-vaccination)
|
81.2 percentage of participants
Interval 79.2 to 83.1
|
82.0 percentage of participants
Interval 78.5 to 85.2
|
|
Immunogenicity Endpoint: Seroprotection Rate
A/H3N2 (pre-vaccination)
|
76.7 percentage of participants
Interval 74.6 to 78.7
|
74.2 percentage of participants
Interval 70.3 to 77.9
|
|
Immunogenicity Endpoint: Seroprotection Rate
B/Yamagata (pre-vaccination)
|
13.0 percentage of participants
Interval 11.4 to 14.7
|
14.2 percentage of participants
Interval 11.3 to 17.5
|
|
Immunogenicity Endpoint: Seroprotection Rate
B/Victoria (pre-vaccination)
|
27.9 percentage of participants
Interval 25.7 to 30.2
|
27.8 percentage of participants
Interval 24.1 to 31.9
|
|
Immunogenicity Endpoint: Seroprotection Rate
A/H1N1 (post-vaccination)
|
99.7 percentage of participants
Interval 99.3 to 99.9
|
99.6 percentage of participants
Interval 98.6 to 100.0
|
|
Immunogenicity Endpoint: Seroprotection Rate
A/H3N2 (post-vaccination)
|
99.4 percentage of participants
Interval 98.9 to 99.7
|
99.4 percentage of participants
Interval 98.3 to 99.9
|
|
Immunogenicity Endpoint: Seroprotection Rate
B/Yamagata (post-vaccination)
|
75.0 percentage of participants
Interval 72.8 to 77.1
|
74.2 percentage of participants
Interval 70.3 to 77.9
|
|
Immunogenicity Endpoint: Seroprotection Rate
B/Victoria (post-vaccination)
|
90.3 percentage of participants
Interval 88.7 to 91.7
|
88.6 percentage of participants
Interval 85.6 to 91.2
|
SECONDARY outcome
Timeframe: 28 days after last vaccination.Population: The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.
The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit
Outcome measures
| Measure |
GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
n=1605 Participants
GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
|
Comparator Quadrivalent Influenza Vaccine
n=528 Participants
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
A/H1N1
|
7.5 Fold Change Titer (GMFI)
Interval 6.99 to 8.01
|
7.3 Fold Change Titer (GMFI)
Interval 6.46 to 8.3
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
A/H3N2
|
10.7 Fold Change Titer (GMFI)
Interval 10.09 to 11.31
|
11.5 Fold Change Titer (GMFI)
Interval 10.32 to 12.71
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
B/Yamagata
|
5.8 Fold Change Titer (GMFI)
Interval 5.44 to 6.08
|
5.2 Fold Change Titer (GMFI)
Interval 4.75 to 5.71
|
|
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
B/Victoria
|
8.3 Fold Change Titer (GMFI)
Interval 7.81 to 8.84
|
7.7 Fold Change Titer (GMFI)
Interval 6.92 to 8.62
|
Adverse Events
Seqirus Quadrivalent Influenza Vaccine
Serious events: 8 serious events
Other events: 1019 other events
Deaths: 0 deaths
Comparator Quadrivalent Influenza Vaccine
Serious events: 2 serious events
Other events: 319 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seqirus Quadrivalent Influenza Vaccine
n=1692 participants at risk
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Comparator Quadrivalent Influenza Vaccine
n=560 participants at risk
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
Infections and infestations
Gasteritis viral
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Infections and infestations
Influenza
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Depression
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.18%
1/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.18%
1/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Injury, poisoning and procedural complications
Pancreatic injury
|
0.06%
1/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
0.00%
0/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
Other adverse events
| Measure |
Seqirus Quadrivalent Influenza Vaccine
n=1692 participants at risk
The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).
Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
Comparator Quadrivalent Influenza Vaccine
n=560 participants at risk
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.
Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
|
|---|---|---|
|
General disorders
Pain
|
49.2%
833/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
45.4%
254/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
General disorders
Swelling
|
13.2%
224/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
11.1%
62/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
General disorders
Redness
|
16.4%
278/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
16.6%
93/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
120/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
7.9%
44/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
86/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
3.8%
21/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Nervous system disorders
Headache
|
14.8%
251/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
12.0%
67/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.6%
213/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
10.7%
60/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
General disorders
Malasia and Fatigue
|
9.0%
152/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
6.4%
36/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
General disorders
Fever
|
3.2%
54/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
2.1%
12/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
34/1692 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
3.2%
18/560 • Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after each vaccination dose. SAEs collected for 180 days after last vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Seqirus agreements and restrictions on publishing may vary with individual investigators; however, Seqirus will not prohibit any investigator from publishing. Seqirus supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER