Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

Influenza Clinical Trial

Official title:

Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858468
• Other study ID #: GRC27
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 5, 2009
• Last updated: April 12, 2016
• Start date: April 2005
• Est. completion date: December 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

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.

Description:

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 9 Months

Eligibility

Inclusion Criteria :

• Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.

• Born at full term of pregnancy (= 36 weeks) with a birth weight = 2.5 kg.

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

• Available for the duration of the study.

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

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

• Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

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.

• Receipt of any vaccine in the 7 days prior to enrollment.

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

• Known bleeding disorder.

• Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this 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 could interfere with trial conduct or completion.

• Known HIV-positive or HBsAg-positive mother.

• Known HIV, hepatitis B (HBsAg), or hepatitis C infection.

• Blood or blood-derived products received in the past 2 months.

• 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: 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 (2004-2005 Formulation)
0.25 mL, Intramuscular
• Influenza virus vaccine (2004-2005 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer = 40 Post-vaccination With Fluzone® (Seroprotection).	Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.; Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers = 40	21 days post-vaccination 2	No
Other	Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of = 10 That Had a Titer of = 40 Post-vaccination With Fluzone® (Seroconversion).	Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a = 4-fold increases in titer from pre- to post-vaccination.	21 days post-vaccination 2	No
Other	Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.	Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.	21 days post-vaccination 2	No
Primary	Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.	Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.	Day 0 to Day 7 post-vaccination	Yes

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