Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    QIV04
Previous Study | Return to List | Next Study

Study of Quadrivalent Influenza Vaccine Among Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01240746
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : January 14, 2014
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE November 11, 2010
First Posted Date  ICMJE November 15, 2010
Results First Submitted Date  ICMJE July 3, 2013
Results First Posted Date  ICMJE January 14, 2014
Last Update Posted Date July 14, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
  • Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
  • Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
  • Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
  • Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. [ Time Frame: Day 28 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2010)
Information on the immune response to each of the four influenza virus strains at 21 days post-vaccination. [ Time Frame: Day 21 post-vaccination ]
Immune response as assessed by seroconversion rates and geometric mean titer ratios for each of the four virus strains separately post-vaccination.
Change History Complete list of historical versions of study NCT01240746 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2010)
Information on the safety of the influenza virus vaccines in terms of solicited and unsolicited adverse events post-vaccination [ Time Frame: Day O up to 6 months post-vaccination ]
Safety will be assessed in terms of solicited injection-site and systemic adverse reactions collected for 7 days after each vaccination, unsolicited adverse events collected from Visit 1 to Visit 2, or Visit 1 to Visit 3 and adverse events of special interest and serious adverse events collected for up to 6 months after the final vaccination.
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2013)
  • Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination
  • Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)
  • Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.
  • Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.
  • Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
  • Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. [ Time Frame: Day 28 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
  • Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants [ Time Frame: Day 28 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
  • Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants [ Time Frame: Day 28 post final vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
  • Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable. Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity.
  • Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Quadrivalent Influenza Vaccine Among Children
Official Title  ICMJE Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine
Brief Summary

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children.

Primary Objective:

To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age

Secondary Objective:

To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates.

Observational Objective:

To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Detailed Description Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
    0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular
    Other Name: Fluzone®
  • Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
    0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular
  • Biological: Quadrivalent Influenza Vaccine, No Preservative
    0.25 mL (6 to 35 months), or 0.5 mL(3 to <9 years), Intramuscular
Study Arms  ICMJE
  • Active Comparator: Group 1: Licensed 2010-2011 TIV
    Participants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain.
    Intervention: Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
  • Experimental: Group 2: Investigational TIV
    Participants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain
    Intervention: Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
  • Experimental: Group 3: Investigational QIV
    Participants will receive the investigational Quadrivalent Influenza Vaccine
    Intervention: Biological: Quadrivalent Influenza Vaccine, No Preservative
Publications * Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014 Jun;33(6):630-6. doi: 10.1097/INF.0000000000000254.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2012)
4363
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2010)
4940
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is 6 months to < 9 years of age on the day of inclusion.
  • Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Subject is in reasonably good health as assessed by the Investigator.
  • Informed consent is granted by the parent(s) or other legally acceptable representative; assent by subjects 7 to < 9 years of age.
  • For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

  • History of allergy to egg proteins or any constituents of the vaccine.
  • History of serious adverse reaction to any influenza vaccine.
  • Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for those requiring two doses).
  • Receipt of any vaccine in the 4 weeks preceding the first study vaccination.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Personal history of Guillain-Barré syndrome.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Personal or immediate family history of congenital immune deficiency.
  • Personal developmental delay, neurologic disorder, or seizure disorder.
  • Any chronic illness that, in the opinion of the Investigator, is not well controlled and may interfere with trial conduct or completion, or with assessment of adverse events.
  • Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
  • Receipt of blood or blood-derived products (including immunoglobulin therapy) in the past 3 months, which might interfere with assessment of the immune response.
  • Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01240746
Other Study ID Numbers  ICMJE QIV04
UTN: U1111-1114-3713 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP