Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 4/21/2016 |
| Start Date: | September 2008 |
| End Date: | January 2009 |
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
Primary Objective:
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from
healthy children receiving the 2008-2009 formulation of the inactivated, split-virion
influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,
administered in a one- or two-dose schedule in accordance with Advisory Committee on
Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,
administered in a one- or two-dose schedule in accordance with ACIP recommendations, in
children ≥ 6 months to < 5 years of age.
To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from
healthy children receiving the 2008-2009 formulation of the inactivated, split-virion
influenza vaccine Fluzone® for further study.
Observational Objectives:
To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine,
administered in a one- or two-dose schedule in accordance with Advisory Committee on
Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.
To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine,
administered in a one- or two-dose schedule in accordance with ACIP recommendations, in
children ≥ 6 months to < 5 years of age.
The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that
all healthy children aged 6 through 59 months receive influenza vaccine. Because of the
growing emphasis on influenza immunization of infants and young children, Center for
Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from
children who have been vaccinated with the current formulation of Fluzone® vaccine. These
sera will be tested to evaluate each individual's immune response to the current formulation
of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order
to support formulation recommendations for the subsequent year (particularly for influenza B
strains, which predominantly affect the young).
all healthy children aged 6 through 59 months receive influenza vaccine. Because of the
growing emphasis on influenza immunization of infants and young children, Center for
Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from
children who have been vaccinated with the current formulation of Fluzone® vaccine. These
sera will be tested to evaluate each individual's immune response to the current formulation
of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order
to support formulation recommendations for the subsequent year (particularly for influenza B
strains, which predominantly affect the young).
Inclusion Criteria:
- Participant is ≥ 6 months to < 5 years of age.
- Participant is considered to be in good health on the basis of reported medical
history and a limited history-directed physical examination.
- Parent/legal acceptable representative is willing and able to bring the subject to
the scheduled visits and to comply with the study procedures during the entire
duration of the study.
- Parent/legal acceptable representative is willing and able to provide informed
consent.
- Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
(5.5 lbs).
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the
vaccine.
- History of severe adverse event to any influenza vaccine.
- Laboratory-confirmed influenza infection or vaccination against influenza in the 6
months preceding enrollment in the study.
- Any vaccination scheduled between Visit 1 and Visit 2.
- Planned participation in any other interventional clinical trial during participation
in the study.
- 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 Human immunodeficiency virus (HIV)-positive mother.
- Prior personal history of Guillain-Barré syndrome.
- Any condition which, in the opinion of the Investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM)
vaccination.
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