At a glance
ClinicalIndex Comparison Record- ✓Age ≥6 months to <36 months
- ✓Good health based on medical history and limited physical examination
- ✓Born at ≥37 weeks gestation with birth weight ≥2.5 kg
- ✓Available for study duration
- ✕Allergy to egg proteins, chicken proteins, or vaccine components
- ✕Prior influenza infection
- ✕Acute illness with or without fever (≥100.4 °F rectal) in 72 hours before enrollment
- ✕Immunocompromise or immunosuppressive therapy/immunoglobulin since birth
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
In Brief
A Phase 4 clinical trial evaluating Influenza Virus Vaccine (Fluzone®) for Influenza. Completed, enrolled 30 participants across 1 site.
Detailed Summary
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.
Study Details
Timeline
Interventions
0.25 mL, Intramuscular (Day 0 and Day 28)
0.25 mL, Intramuscular (Day 0)