Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

Influenza Clinical Trial

Official title:

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561002
• Other study ID #: GRC38
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2007
• Last updated: April 12, 2016
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria:

• Participant is aged = 6 months (24 weeks) to < 36 months (3rd birthday).

• Participant is considered to be in good health on the basis of reported medical history and limited physical examination.

• Participant is available for the duration of the study.

• Parent/legal acceptable representative is willing and able to provide informed consent.

• Parent/legal acceptable representative is willing and able to meet protocol requirements.

• 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.

• An acute illness with or without fever (For infants/toddlers: temperature = 100.4°F rectal; For children: temperature = 99.5°F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).

• Clinically significant findings in vital signs or review of systems (Investigator judgment; defer or exclude).

• Participation in any other interventional clinical trial within 30 days prior to enrollment or planned 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.

• Received any vaccinations within the preceding 14 days (enrollment may be deferred).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular
• 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination		Day 0 and Day 14 after last dose of Fluzone	No
Other	Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)	Seroprotection was defined as a serum hemagglutination inhibition antibody titer =40.	Day 14 post-vaccination	No
Other	Seroconversion Rates for Each Influenza Antigen Post-Vaccination	Seroconversion was defined as a post-vaccination titer = 40 for participants with a titer < 10 on Day 0 and a =4-fold increase for participants with a titer = 10 on Day 0.	Day 14 post-vaccination	No
Primary	Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation	Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.	Days 0-3 post-dose	Yes

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