A Study of Influenza Virus Vaccines in Children and Adults

NCT00988143 | Completed Phase 2 Results

• 2 other identifiers: GRC43UTN: U1111-1111-5427
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives:

• To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
• To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Conditions

Influenza

Keywords

Influenza; Trivalent Influenza Virus Vaccine; Quadrivalent Influenza Virus Vaccine

Outcome Measures

Primary Outcomes (3)

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.

  Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.

  Day 0 up to 7 days post-vaccination

• Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult 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.

  21 Days post last vaccination

• Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult 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.

  21 Days post last vaccination

Other Outcomes (6)

• Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine

  Day 0 (pre-vaccination) and Day 21 post final vaccination

• Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants

  21 Days post last vaccination

• Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines

  Day 21 post-vaccination

Study Arms (3)

Study Group 1

EXPERIMENTAL

Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives)

Biological: 2009-2010 Trivalent Influenza Virus Vaccine

Study Group 2

ACTIVE COMPARATOR

Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV)

Biological: 2008-2009 Trivalent Influenza Virus Vaccine

Study Group 3

ACTIVE COMPARATOR

Participants will receive the Quadrivalent Influenza Vaccine (QIV)

Biological: Quadrivalent Influenza Virus Vaccine

Interventions

2009-2010 Trivalent Influenza Virus Vaccine BIOLOGICAL

0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.

Also known as: Fluzone®

Study Group 1

2008-2009 Trivalent Influenza Virus Vaccine BIOLOGICAL

0.25 mL, Intramuscular; 0.5 mL, Intramuscular.

Also known as: Fluzone®

Study Group 2

Quadrivalent Influenza Virus Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Study Group 3

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
• Subject in reasonably good health as assessed by the Investigator.
• Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to give informed consent.
• For subjects ≥ 6 months to \< 5 years of age: subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
• For a woman, inability to bear a child or negative serum/urine pregnancy test, if applicable.

You may not qualify if:

• For all subjects:
• History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
• History of serious adverse reaction to any influenza vaccine.
• Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study.
• Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.
• Participation in any other interventional drug or vaccine trial during participation in this study.
• Thrombocytopenia or bleeding disorder 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.
• Prior personal history of Guillain-Barré syndrome.
• For subjects \> 6 months to \< 5 years of age:
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay, neurologic disorder, or seizure disorder.
• Chronic medical, congenital, or developmental disorder.
• Known HIV-positive mother.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Unknown Facility

Durham, North Carolina, 27704, United States

Location

Unknown Facility

Cincinnati, Ohio, 45249, United States

Location

Unknown Facility

Jefferson Hills, Pennsylvania, 15025, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: December 12, 2013
• Results First Posted: December 12, 2013

Record last verified: 2013-11

Locations

US (4)