Clinical trial NCT00988143: A Study of Influenza Virus Vaccines in Children and Adults
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Trivalent Influenza Virus Vaccine
Quadrivalent Influenza Virus Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
timeFrame: Day 0 up to 7 days post-vaccination
measure: Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
timeFrame: 21 Days post last vaccination
measure: Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
timeFrame: 21 Days post last vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 21 post final vaccination
measure: Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants
timeFrame: 21 Days post last vaccination
measure: Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
timeFrame: Day 21 post-vaccination
measure: Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants
timeFrame: 21 Days post last vaccination
measure: Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
timeFrame: Day 0 up to 21 days post-vaccination
measure: Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
timeFrame: Day 0 (pre-vaccination) and Day 21 post final vaccination
Locations:
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Jefferson Hills
country: United States
state: Pennsylvania
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: