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CompletedNCT02545543Updated May 23, 2018Results posted

A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age

A Phase 3 interventional study of Seqirus QIV and Comparator QIV in Influenza, Human, sponsored by Seqirus. Completed at 32 sites in United States. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-23.

Sponsored by Seqirus · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,278
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study summary

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.

02

Conditions studied

  • Influenza, Human

Browse trials for

03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 2,278 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Seqirus is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males or females 5 through 17 years of age on the day of first study vaccination.
  • Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws. Participant assent will also be obtained if required.
  • If applicable, females of childbearing potential (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine.

Exclusion criteria

Exclusion Criteria:

  • History of allergic reactions to egg proteins or any components of the Study Vaccines.
  • History of serious adverse reactions to any influenza vaccines.
  • History of Guillain-Barré syndrome or other demyelinating disease.
  • History of licensed or investigational influenza vaccination in the last 6 months.
  • Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on the day of planned Study Vaccine administration or within 48 hours preceding vaccination.
  • Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable (such as illness exacerbations) within the preceding 30 days.
  • History of any seizures, with the exception of a single febrile seizure.
  • Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C.
  • Known or suspected congenital or acquired immunosuppressive conditions.

  • Current or recent immunosuppressive or immunomodulatory therapy, as follows:

    • Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral prednisolone or equivalent daily;
    • Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination;
    • Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination.

Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable.

  • Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study.
  • Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period.
  • Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
  • Pregnant or lactating females.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,278 participants (actual)

Study arms

  • Experimental
    Seqirus Quadrivalent Inactivated 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).

    Biological: Seqirus QIV

  • Active comparator
    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.

    Biological: Comparator QIV

Interventions

  • BiologicalSeqirus 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.

  • BiologicalComparator 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.

    Also known as: Fluarix Quadrivalent

06

What researchers measure

Primary outcomes

  1. The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.

    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.

    Time frame: 28 days after last vaccination.

  2. The Difference in Seroconversion Rate (SCR) for Each Virus Strain.

    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.

    Time frame: 28 days after last vaccination.

Secondary outcomes

  1. Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.

    Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

    Time frame: 7 days after each vaccination.

  2. Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).

    Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

    Time frame: 7 days after each vaccination.

  3. Safety Endpoint: The Frequency of Cellulitis-like Reaction.

    Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose

    Time frame: 28 days after each vaccination.

  4. Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).

    Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose

    Time frame: 28 days after each vaccination.

  5. Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).

    Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.

    Time frame: 180 days after the last vaccination dose.

  6. Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)

    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

    Time frame: 28 days after last vaccination.

  7. Immunogenicity Endpoint: Seroconversion Rate (SCR)

    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

    Time frame: 28 days after last vaccination.

  8. Immunogenicity Endpoint: Seroprotection Rate

    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

    Time frame: 28 days after last vaccination.

  9. Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)

    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

    Time frame: 28 days after last vaccination.

07

Results

Posted Apr 18, 2017

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).

Participant flow — Overall Study
MilestoneSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Started1709569
Completed1628535
Not completed8134
Withdrew: Lost to follow-up6725
Withdrew: Physician decision30
Withdrew: Withdrawal by subject98
Withdrew: Noncomplaince10
Withdrew: Enrolment of subject at >1 study site11

Outcome measures

PrimaryThe Geometric Mean Titer (GMT) Ratio of Each Virus Strain.

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.

Time frame:
28 days after last vaccination.
Reported as:
Geometric mean · Ratio
The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
RatioGMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV
A/H1N11.01 (0.93 to 1.09)
A/H3N21.05 (0.96 to 1.15)
B/Yamagata0.89 (0.81 to 0.98)
B/Victoria0.92 (0.83 to 1.02)
PrimaryThe Difference in Seroconversion Rate (SCR) for Each Virus Strain.

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.

Time frame:
28 days after last vaccination.
Reported as:
Number · percentage of participants
The Difference in Seroconversion Rate (SCR) for Each Virus Strain.
percentage of participantsSCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR %
A/H1N1-3.1 (-8.0 to 1.8)
A/H3N20.4 (-4.5 to 5.3)
B/Yamagata-3.4 (-8.3 to 1.5)
B/Victoria-2.0 (-6.9 to 2.9)
SecondarySafety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.

Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

Time frame:
7 days after each vaccination.
Reported as:
Number · participants
Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.
participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Frequency of Solicited Local AEs909279
Severe (Grade 3) Solicited Local AEs7121
SecondarySafety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).

Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose

Time frame:
7 days after each vaccination.
Reported as:
Number · participants
Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).
participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Frequency of Solicited Systemic AEs499147
Severe (Grade 3) Solicited Systemic AEs246
SecondarySafety Endpoint: The Frequency of Cellulitis-like Reaction.

Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose

Time frame:
28 days after each vaccination.
Reported as:
Number · participants
Safety Endpoint: The Frequency of Cellulitis-like Reaction.
participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Safety Endpoint: The Frequency of Cellulitis-like Reaction.10
SecondarySafety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).

Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose

Time frame:
28 days after each vaccination.
Reported as:
Number · participants
Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).
participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
At least one Unsolicited AE26970
Severe (Grade 3) Unsolicited AE116
SecondarySafety Endpoint: The Frequency of Serious Adverse Events (SAEs).

Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.

Time frame:
180 days after the last vaccination dose.
Reported as:
Number · participants
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).82
SecondaryImmunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)

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

Time frame:
28 days after last vaccination.
Reported as:
Geometric mean · Titer
Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)
TiterSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
A/H1N1 (pre-vaccination)114.8 (106.79 to 123.33)119.5 (105.48 to 135.38)
A/H3N2 (pre-vaccination)75.2 (70.80 to 79.88)72.1 (64.61 to 80.40)
B/Yamagata (pre-vaccination)10.5 (10.12 to 10.99)10.4 (9.69 to 11.22)
B/Victoria (pre-vaccination)17.0 (16.10 to 17.85)16.9 (15.42 to 18.46)
A/H1N1 (post-vaccination)858.7 (821.46 to 897.65)875.1 (814.14 to 940.59)
A/H3N2 (post-vaccination)803.6 (763.01 to 846.26)825.6 (756.12 to 901.55)
B/Yamagata (post-vaccination)60.7 (57.52 to 64.01)54.3 (49.65 to 59.28)
B/Victoria (post-vaccination)140.9 (132.97 to 149.26)130.3 (117.07 to 145.06)
SecondaryImmunogenicity Endpoint: Seroconversion Rate (SCR)

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

Time frame:
28 days after last vaccination.
Reported as:
Number · percentage of participants
Immunogenicity Endpoint: Seroconversion Rate (SCR)
percentage of participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
A/H1N166.4 (64.0 to 68.7)63.3 (59.0 to 67.4)
A/H3N282.9 (81.0 to 84.7)83.3 (79.9 to 86.4)
B/Yamagata58.5 (56.0 to 60.9)55.1 (50.8 to 59.4)
B/Victoria72.1 (69.8 to 74.3)70.1 (66.0 to 74.0)
SecondaryImmunogenicity Endpoint: Seroprotection Rate

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

Time frame:
28 days after last vaccination.
Reported as:
Number · percentage of participants
Immunogenicity Endpoint: Seroprotection Rate
percentage of participantsSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
A/H1N1 (pre-vaccination)81.2 (79.2 to 83.1)82.0 (78.5 to 85.2)
A/H3N2 (pre-vaccination)76.7 (74.6 to 78.7)74.2 (70.3 to 77.9)
B/Yamagata (pre-vaccination)13.0 (11.4 to 14.7)14.2 (11.3 to 17.5)
B/Victoria (pre-vaccination)27.9 (25.7 to 30.2)27.8 (24.1 to 31.9)
A/H1N1 (post-vaccination)99.7 (99.3 to 99.9)99.6 (98.6 to 100.0)
A/H3N2 (post-vaccination)99.4 (98.9 to 99.7)99.4 (98.3 to 99.9)
B/Yamagata (post-vaccination)75.0 (72.8 to 77.1)74.2 (70.3 to 77.9)
B/Victoria (post-vaccination)90.3 (88.7 to 91.7)88.6 (85.6 to 91.2)
SecondaryImmunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)

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

Time frame:
28 days after last vaccination.
Reported as:
Geometric mean · Fold Change Titer (GMFI)
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)
Fold Change Titer (GMFI)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
A/H1N17.5 (6.99 to 8.01)7.3 (6.46 to 8.30)
A/H3N210.7 (10.09 to 11.31)11.5 (10.32 to 12.71)
B/Yamagata5.8 (5.44 to 6.08)5.2 (4.75 to 5.71)
B/Victoria8.3 (7.81 to 8.84)7.7 (6.92 to 8.62)

Adverse events

Collected over 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.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Seqirus Quadrivalent Influenza Vaccine—8/1,692 (0.5%)1,019/1,692 (60.2%)
Comparator Quadrivalent Influenza Vaccine—2/560 (0.4%)319/560 (57%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
Suicide attemptPsychiatric disorders0/16921/560
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/16921/560
Gasteritis viralInfections and infestations1/16920/560
InfluenzaInfections and infestations1/16920/560
DepressionPsychiatric disorders1/16920/560
Attention deficit/hyperactivity disorderPsychiatric disorders1/16920/560
Bipolar disorderPsychiatric disorders1/16920/560
Psychotic disorderPsychiatric disorders1/16920/560
Suicidal ideationPsychiatric disorders1/16920/560
Abdominal painGastrointestinal disorders1/16920/560
Most frequent other events
Most frequent other events
EventSeqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza Vaccine
PainGeneral disorders833/1692254/560
RednessGeneral disorders278/169293/560
HeadacheNervous system disorders251/169267/560
SwellingGeneral disorders224/169262/560
MyalgiaMusculoskeletal and connective tissue disorders213/169260/560
Malasia and FatigueGeneral disorders152/169236/560
NauseaGastrointestinal disorders120/169244/560
DiarrheaGastrointestinal disorders86/169221/560
VomitingGastrointestinal disorders34/169218/560
FeverGeneral disorders54/169212/560

Baseline characteristics

The Full Analysis Set (FAS) was used for analysis of subject characteristics and comprised all subjects who gave informed consent and who were randomized to treatment. Screening failures were not included in the FAS.

Age, Continuous
Age, Continuous(years)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
Mean9.5 ± 3.499.5 ± 3.469.5 ± 3.48
Age, Customized
Age, Customized(Participants)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
5 through 8 years8752911166
9 through 17 years8342781112
Sex: Female, Male
Sex: Female, Male(Participants)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
Female8252671092
Male8843021186
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
Hispanic or Latino412130542
Not Hispanic or Latino12934381731
Unknown or Not Reported415
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
American Indian or Alaska Native527
Asian16218
Native Hawaiian or Other Pacific Islander13215
Black or African American359113472
White12394301669
More than one race000
Unknown or Not Reported772097
Region of Enrollment
Region of Enrollment(participants)Seqirus Quadrivalent Influenza VaccineComparator Quadrivalent Influenza VaccineTotal
United States17095692278
08

Study locations

32 sites
  • Site 296
    Huntsville, Alabama 35802, United States
  • Site 401
    Madera, California 93637, United States
  • Site 397
    Ontario, California 91762, United States
  • Site 392
    Redding, California 96001, United States
  • Site 402
    Sacramento, California 95822, United States
  • Site 398
    San Jose, California 95127, United States
  • Site 388
    Hialeah, Florida 33012, United States
  • Site 293
    Melbourne, Florida 32934, United States
  • Site 289
    Boise, Idaho 83642, United States
  • Site 294
    Peoria, Illinois 61614, United States
  • Site 390
    Augusta, Kansas 67010, United States
  • Site 396
    Newton, Kansas 67114, United States
  • Site 400
    Park City, Kansas 67219, United States
  • Site 317
    Wichita, Kansas 67207, United States
  • Site 386
    Bardstown, Kentucky 40004, United States
  • Site 393
    Metairie, Louisiana 70002, United States
  • Site 287
    Saint Louis, Missouri 63141, United States
  • Site 316
    Bellevue, Nebraska 68005, United States
  • Site 382
    Omaha, Nebraska 68114, United States
  • Site 285
    Binghamton, New York 13901, United States
  • Site 387
    Cary, North Carolina 27511, United States
  • Site 385
    Cincinnati, Ohio 45246, United States
  • Site 383
    Cleveland, Ohio 44122, United States
  • Site 399
    Dayton, Ohio 45414, United States
  • Site 384
    Grove City, Ohio 43123, United States
  • Site 389
    Gresham, Oregon 97030, United States
  • Site 283
    Austin, Texas 78705, United States
  • Site 282
    Fort Worth, Texas 76135, United States
  • Site 288
    San Angelo, Texas 76904, United States
  • Site 394
    San Antonio, Texas 78229, United States
  • Site 395
    Layton, Utah 84041, United States
  • Site 300
    Salt Lake City, Utah 84124, United States
09

References and documents

Publications

  • Airey J, Albano FR, Sawlwin DC, Jones AG, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: A phase 3, randomized noninferiority study. Vaccine. 2017 May 9;35(20):2745-2752. doi: 10.1016/j.vaccine.2017.03.028. Epub 2017 Apr 5. PubMed 28390934 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02545543
Lead sponsor
Seqirus
Responsible party
Sponsor
First posted
Sep 10, 2015
Start date
Sep 2015
Primary completion
Jan 2016
Completion
Jun 2016
Results posted
Apr 18, 2017
Last update
May 23, 2018

Study contacts

Clinical Development Physician Seqirus
study director · Seqirus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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