Back to results

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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Influenza virus vaccine (2004-2005 Formulation)

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Influenza vaccine

Eligibility Criteria

2 Months - 9 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Participants aged 6 to 12 Weeks at enrollment

Participants aged 24 to 36 Weeks at enrollment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00858468

First Posted

March 5, 2009

Last Updated

April 12, 2016

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00858468

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

394 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Participants aged 6 to 12 Weeks at enrollment

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Participants aged 24 to 36 Weeks at enrollment

Intervention Type

Biological

Intervention Name(s)

Influenza virus vaccine (2004-2005 Formulation)

Other Intervention Name(s)

Fluzone® Preservative-free

Intervention Description

0.25 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Influenza virus vaccine (2004-2005 Formulation)

Other Intervention Name(s)

Fluzone® Preservative-free

Intervention Description

0.25 mL, Intramuscular

Primary Outcome Measure Information:

Title

Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.

Description

Time Frame

Day 0 to Day 7 post-vaccination

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).

Description

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

Time Frame

21 days post-vaccination 2

Title

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).

Description

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.

Time Frame

21 days post-vaccination 2

Title

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.

Description

Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.

Time Frame

21 days post-vaccination 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

9 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs