Phase 2
Completed N=393
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
Source: ClinicalTrials.gov NCT00858468 ↗Enrolled (actual)
393
Serious AEs
1.8%
Results posted
Jul 2009
Primary outcomePrimary: Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. — 54; 47; 50; 44 Percentage of participants
Summary
Primary Objective:
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.
Observational Objective:
To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. |
54; 47; 50; 44; 6; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
- Considered to be in good health on the basis of reported medical history and history-directed physical examination.
- Available for the duration of the study.
- Parent/guardian willing and able to provide informed consent.
- Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
Exclusion Criteria
- Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- Receipt of any vaccine in the 7 days prior to enrollment.
- An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Known bleeding disorder.
- Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 that could interfere with trial conduct or completion.
- Known HIV-positive or HBsAg-positive mother.
- Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
- Blood or blood-derived products received in the past 2 months.
- 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.
Data sourced from ClinicalTrials.gov (NCT00858468). 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.