Study of Safety and Immunogenicity of Fluzone® in Healthy Children

Influenza Clinical Trial

Official title:

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831675
• Other study ID #: GRC21
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: April 12, 2016
• Start date: September 2004
• Est. completion date: April 2006

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 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

Description:

To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria :

• Participant is aged = 6 months to < 36 months.

• 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/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.

• Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.

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:
• Influenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), Intramuscular
• Influenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), 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 Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation		14 days post-vaccination	No
Other	Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)	Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers =40 post-vaccination with Fluzone®.	14 days post-vaccination	No
Other	Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)	Seroconversion defined as the percentage of participants with a = 4-fold increases in titer from pre- to post-vaccination with Fluzone®.	Day 14 post-vaccination	Yes
Primary	Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation	Solicited local reactions: Erythema, bruising, induration, pain at injection site.; Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.	Days 0-3 Post-dose	Yes

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