Phase 4
Completed N=30
Study of Safety and Immunogenicity of Fluzone® in Healthy Children
Source: ClinicalTrials.gov NCT00831675 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation — 3; 7; 0; 2 Participants
Summary
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, 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 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation |
3; 7; 0; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is aged ≥ 6 months to 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's 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 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.
- Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Data sourced from ClinicalTrials.gov (NCT00831675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.