A Study of Influenza Virus Vaccines in Children and Adults

NCT ID: NCT00988143

Last Updated: 2013-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group 1

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

Group Type: EXPERIMENTAL

2009-2010 Trivalent Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

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

Study Group 2

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

Group Type: ACTIVE_COMPARATOR

2008-2009 Trivalent Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

0.25 mL, Intramuscular; 0.5 mL, Intramuscular.

Study Group 3

Participants will receive the Quadrivalent Influenza Vaccine (QIV)

Group Type: ACTIVE_COMPARATOR

Quadrivalent Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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.

Intervention Type: BIOLOGICAL

2008-2009 Trivalent Influenza Virus Vaccine

0.25 mL, Intramuscular; 0.5 mL, Intramuscular.

Intervention Type: BIOLOGICAL

Quadrivalent Influenza Virus Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®; Fluzone®

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.

• 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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Jefferson Hills, Pennsylvania, United States

Norfolk, Virginia, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

UTN: U1111-1111-5427

Identifier Type: OTHER

Identifier Source: secondary_id

GRC43

Identifier Type: -

Identifier Source: org_study_id