Study of Quadrivalent Influenza Vaccine Among Children

NCT01240746 | Completed Phase 3 Results

• 2 other identifiers: QIV04UTN: U1111-1114-3713
• Study Type: interventional
• Target: 4,363
• Locations: 1 country
• Sites: 67

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.

Conditions

Influenza

Keywords

Influenza; Quadrivalent Influenza Vaccine; Trivalent Influenza Vaccine; Influenza viruses; Fluzone®

Outcome Measures

Primary Outcomes (5)

• Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants

  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.

  Day 28 post final vaccination

• 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

  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.

  Day 28 post final vaccination

• 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

  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.

  Day 28 post final vaccination

• 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.

  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.

  Day 28 post final vaccination

• 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.

  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.

  Day 28 post-vaccination

Other Outcomes (10)

• Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants

  Day 28 post final vaccination

• Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants

  Day 28 post final vaccination

• Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants

  Day 28 post final vaccination

Study Arms (3)

Group 1: Licensed 2010-2011 TIV

ACTIVE COMPARATOR

Participants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain.

Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative

Group 2: Investigational TIV

EXPERIMENTAL

Participants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain

Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative

Group 3: Investigational QIV

EXPERIMENTAL

Participants will receive the investigational Quadrivalent Influenza Vaccine

Biological: Quadrivalent Influenza Vaccine, No Preservative

Interventions

Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative BIOLOGICAL

0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular

Also known as: Fluzone®

Group 1: Licensed 2010-2011 TIV

Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative BIOLOGICAL

0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular

Group 2: Investigational TIV

Quadrivalent Influenza Vaccine, No Preservative BIOLOGICAL

0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular

Group 3: Investigational QIV

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (67)

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Dothan, Alabama, 36305, United States

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Chandler, Arizona, 85224, United States

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Chandler, Arizona, 85225, United States

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Mesa, Arizona, 85203, United States

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Mesa, Arizona, 85213, United States

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Scottsdale, Arizona, 85258, United States

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Little Rock, Arkansas, 72205, United States

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Los Angeles, California, 90036, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Colorado Spring, Colorado, 80922, United States

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Denver, Colorado, 80239, United States

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Ridgefield, Connecticut, 06877, United States

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Boca Raton, Florida, 33432, United States

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Jacksonville, Florida, 32216, United States

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Melbourne, Florida, 32935, United States

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Miami Beach, Florida, 33141, United States

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Ponte Vedra, Florida, 32081, United States

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Sarasota, Florida, 34231, United States

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Sarasota, Florida, 34239, United States

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South Miami, Florida, 33143, United States

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Marietta, Georgia, 30625, United States

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Arkansas City, Kansas, 67005, United States

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Newton, Kansas, 67114, United States

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Overland Park, Kansas, 66202, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Bardstown, Kentucky, 40004, United States

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Crestview Hills, Kentucky, 41017, United States

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Lexington, Kentucky, 40509, United States

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Metairie, Louisiana, 70006, United States

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Columbia, Maryland, 21045, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89104, United States

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Binghamton, New York, 13901, United States

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Cary, North Carolina, 27518, United States

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Akron, Ohio, 44311, United States

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Cleveland, Ohio, 44121, United States

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Columbus, Ohio, 43212, United States

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Portland, Oregon, 97203, United States

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Pittsburgh, Pennsylvania, 15220, United States

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Pittsburgh, Pennsylvania, 15227, United States

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Scranton, Pennsylvania, 18510, United States

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Warwick, Rhode Island, 02886, United States

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Barnwell, South Carolina, 26812, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Clarksville, Tennessee, 37043, United States

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Kingsport, Tennessee, 37664, United States

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Austin, Texas, 78705, United States

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Fort Worth, Texas, 76107, United States

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Fort Worth, Texas, 76135, United States

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Houston, Texas, 77074, United States

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Katy, Texas, 77450, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84107, United States

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Orem, Utah, 84057, United States

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Provo, Utah, 84604, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Salt Lake City, Utah, 84124, United States

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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 84088, United States

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Charlottesville, Virginia, 22902, United States

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Midlothian, Virginia, 23113, United States

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Williamsburg, Virginia, 23185, United States

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Marshfield, Wisconsin, 54449, United States

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Related Publications (1)

• 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.

  PMID: 24445833 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 14, 2015
• Results First Posted: January 14, 2014

Record last verified: 2015-06

Locations

US (67)