Trial to Collect Safety Data and Sera for Immunogenicity Testing

Influenza Clinical Trial

Official title:

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389857
• Other study ID #: GRC34
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2006
• Last updated: April 12, 2016
• Start date: October 2006
• Est. completion date: July 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 Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 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 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 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.

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 Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (infant/children dose)
• Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (infant/children dose)

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	Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.	Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).	0 to 3 days post-vaccination 1	Yes
Other	Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.	Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).; Note: Influenza vaccine-primed group did not receive vaccination 2	0 to 3 days post-vaccination 2	Yes
Primary	Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination	GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.; Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)	14 days post-vaccination	No

External Links

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