Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

Influenza Clinical Trial

Official title:

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755274
• Other study ID #: GRC40
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: April 12, 2016
• Start date: September 2008
• Est. completion date: January 2009

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 provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Observational Objectives:

To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.

Description:

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• Participant is = 6 months to < 5 years of age.

• Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.

• Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.

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

• Subject was 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.

• History of severe adverse event to any influenza vaccine.

• Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.

• Any vaccination scheduled between Visit 1 and Visit 2.

• Planned participation in any other interventional clinical trial during 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.

• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

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
• Orthomyxoviridae Infections

Intervention

Biological:
• Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
• Influenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

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 Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination		Day 28 post-single dose or Day 21 post-Dose 2	No
Other	Percentage of Participants With Influenza Titers = 1:40 After Fluzone® Vaccination (Seroprotection)	Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer = 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.	Day 28 post-single dose or Day 21 post-Dose 2	No
Other	Percentage of Participants With Influenza Titers = 1:40 After Fluzone® Vaccination (Seroprotection)	Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer = 1:40. Data presented for participants enrolled at age 36 to 59 months.	Day 28 post-single dose or Day 21 post-Dose 2	No
Other	Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)	Seroconversion was defined as a = 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.	Day 28 post-single dose or Day 21 post-Dose 2	No
Other	Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)	Seroconversion was defined as a = 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.	Day 28 post-single dose or Day 21 post-Dose 2	No
Primary	Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1	Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.	Day 0 to Day 3 post-vaccination 1	Yes
Primary	Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2	Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.	Day 0 to Day 3 post-vaccination 2	Yes

External Links

•   Link
•   Link