Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390884
• Other study ID #: GRC29
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2006
• Last updated: April 12, 2016
• Start date: October 2006
• Est. completion date: September 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 compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Months to 14 Months

Eligibility

Inclusion Criteria :

• Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.

• Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.

• Available for the duration of the study.

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

• Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.

• Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

Exclusion Criteria :

• Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)

• Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.

• Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.

• An acute illness with fever (rectal temperature = 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).

• Known bleeding disorder.

• Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the investigator, could interfere with trial conduct or completion.

• Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.

• Known HIV, Hepatitis B, or Hepatitis C infection.

• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.

• Prior personal history of Guillain-Barré syndrome.

• Any condition that, 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
• Influenza Virus Vaccine, Fluzone®
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	Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®	Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination	Days 0-7 Post-vaccination	Yes
Primary	Percentage of Seroprotected Participants Post-vaccination With Fluzone®	Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.	Day 28 Post-vaccination	No
Secondary	Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®	Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.	Day 28 Post-vaccination	No

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