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A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

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ClinicalTrials.gov Identifier: NCT02914275
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief 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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: Seqirus Quadrivalent Inactivated Influenza Vaccine Biological: Comparator Quadrivalent Inactivated Influenza Vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : March 9, 2017
Actual Study Completion Date : August 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Seqirus QIV Cohort A
Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age
Biological: 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 (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.
Other Name: Seqirus QIV

Experimental: Seqirus QIV Cohort B
Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age
Biological: 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 (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.
Other Name: Seqirus QIV

Active Comparator: Comparator QIV Cohort A
Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age
Biological: Comparator Quadrivalent Inactivated Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
Other Name: Comparator QIV

Active Comparator: Comparator QIV Cohort B
Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age
Biological: Comparator Quadrivalent Inactivated Influenza Vaccine
The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
Other Name: Comparator QIV




Primary Outcome Measures :
  1. The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. [ Time Frame: Postvaccination (28 days after last vaccination) ]

    Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) 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.

    B/VIC = B/Victoria B/YAM = B/Yamagata


  2. The Difference in Seroconversion Rate (SCR) for Each Virus Strain. [ Time Frame: Postvaccination (28 days after last vaccination) ]
    Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. 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 vaccine (for each strain) will be determined.


Secondary Outcome Measures :
  1. Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) [ Time Frame: Postvaccination (up to 7 days after vaccination) ]
    Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose

  2. Number of Participants With Cellulitis-like Reactions [ Time Frame: Postvaccination (up to 28 days after each vaccination) ]
    Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose

  3. Number of Participants With Unsolicited AEs [ Time Frame: Postvaccination (up to 28 days after vaccination) ]
    Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose

  4. Number of Participants With Serious Adverse Events (SAE) [ Time Frame: 180 days after the last vaccination dose. ]
    Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest

  5. Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain [ Time Frame: 28 days after last vaccination. ]
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination & postvaccination.

  6. Seroconversion Rates (SCRs) of Each Virus Strain [ Time Frame: 28 days after last vaccination ]
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % 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.

  7. Seroprotection Rates of Each Virus Strain [ Time Frame: 28 days after last vaccination. ]
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.

  8. Geometric Mean Fold Increase (GMFI) of Each Virus Strain [ Time Frame: Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) ]
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
  • 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.
  • Subject is in generally good health as per the Investigator's medical judgment

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 such as encephalomyelitis and transverse myelitis;
  • History of licensed or investigational influenza vaccination in the last 6 months;
  • Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination 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
  • 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
  • Current or medical history of malignant neoplasms;
  • Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
  • Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
  • Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
  • Medical conditions or treatment contraindicating intramuscular vaccination due to increased risk of bleeding.
  • Family members of the employees of the Investigator or study center with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study center.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914275


  Show 39 Study Locations
Sponsors and Collaborators
Seqirus
  Study Documents (Full-Text)

Documents provided by Seqirus:
Study Protocol  [PDF] May 24, 2016
Statistical Analysis Plan  [PDF] August 22, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02914275     History of Changes
Other Study ID Numbers: CSLCT-QIV-15-03
First Posted: September 26, 2016    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs