A Study of Influenza Virus Vaccines in Children and Adults

Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: 2009-2010 Trivalent Influenza Virus Vaccine; Biological: 2008-2009 Trivalent Influenza Virus Vaccine; Biological: Quadrivalent Influenza Virus Vaccine

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
  • Ohio
    • Cincinnati, Ohio, United States, 45249
  • Pennsylvania
    • Jefferson Hills, Pennsylvania, United States, 15025
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria :

• Subject is ≥ 6 months to < 5 years of age or 18 years of age or older on the day of inclusion.
• 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.

Exclusion Criteria :

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.

For subjects 18 years of age and older:

• Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
• Diabetes mellitus requiring pharmacological control.
• Person deprived of freedom by an administrative or court order (having legal or medical guardian).
• For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
• Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.

• Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/exclusion criteria:

  • An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs or review of systems (Investigator judgment).
  • Received any vaccinations within the preceding 14 days.
  • Participation in any other interventional clinical trial within 30 days prior to enrollment.
  • Receipt of blood or blood products within the three months preceding enrollment in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1; Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives)	Biological: 2009-2010 Trivalent Influenza Virus Vaccine; 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.; Other Names: Fluzone®
Active Comparator: Study Group 2; Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV)	Biological: 2008-2009 Trivalent Influenza Virus Vaccine; 0.25 mL, Intramuscular; 0.5 mL, Intramuscular.; Other Names: Fluzone®
Active Comparator: Study Group 3; Participants will receive the Quadrivalent Influenza Vaccine (QIV)	Biological: Quadrivalent Influenza Virus Vaccine; 0.5 mL, Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine	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 to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)	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	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.	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	Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.	Day 21 post-vaccination
Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study 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.	21 Days post last vaccination
Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines	Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.	Day 0 up to 21 days post-vaccination
Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines	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 to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil).	Day 0 (pre-vaccination) and Day 21 post final vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (Estimate): October 2, 2009

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Influenza; Trivalent Influenza Virus Vaccine; Quadrivalent Influenza Virus Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GRC43; UTN: U1111-1111-5427 (Other Identifier: WHO)