Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

Influenza Clinical Trial

Official title:

A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836953
• Other study ID #: GRC17
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2009
• Last updated: April 12, 2016
• Start date: September 2003
• Est. completion date: July 2004

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 describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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

Description:

The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

Inclusion Criteria :

• Aged = 6 months to < 36 months.

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

• Available for the duration of the study (44 days +4 days).

• Parent/guardian is willing and able to provide informed consent.

• Parent/guardian is willing and able to meet protocol requirements.

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.

• An acute illness with or without fever (temperature > 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.

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza virus vaccine (Pediatric formulation)
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, 

References & Publications (1)

Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers = 40 (Seroprotection)	Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers =40 pre- and post-vaccination.	Day 0 and Day 14 after Dose 2	No
Other	Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)	Seroconversion defined as the percentage of participants with = 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.	Day 0 and Day 14 Post-dose 2	No
Primary	Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination	Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.	Day 0 to 3 post-vaccination	Yes

External Links

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