Back to resultsEvaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Influenza Virus Vaccine
Influenza Virus Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Fluzone® vaccine, Influenza
Eligibility Criteria
Inclusion Criteria:
- Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
- Available for the duration of the study.
- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
- Parent/legal acceptable representative willing and able to provide informed consent.
- Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
- Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.
Exclusion Criteria:
- Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
- Previous history of influenza vaccination (Group 2 subjects only).
- Receipt of any vaccine in the 14 days prior to enrollment.
- An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
- Known bleeding disorder.
- Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional 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 human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
- Known HIV, hepatitis B, or hepatitis C infection.
- Receipt of blood or blood-derived products within 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
Active Comparator
Arm Label
Fluzone® Vaccine-Primed Group
Influenza Vaccine-Naive Group
Arm Description
Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
Participants who have never received influenza vaccine (and not in Study GRC27)
Outcomes
Primary Outcome Measures
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Secondary Outcome Measures
Full Information
NCT ID
NCT00885105
First Posted
April 20, 2009
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00885105
Brief Title
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Official Title
Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.
Observational Objectives:
To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
Detailed Description
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Fluzone® vaccine, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluzone® Vaccine-Primed Group
Arm Type
Experimental
Arm Description
Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
Arm Title
Influenza Vaccine-Naive Group
Arm Type
Active Comparator
Arm Description
Participants who have never received influenza vaccine (and not in Study GRC27)
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone® 2005-2006 Pediatric Formulation
Intervention Description
0.25 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone® 2005-2006 Pediatric Formulation
Intervention Description
0.25 mL, Intramuscular
Primary Outcome Measure Information:
Title
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Description
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Time Frame
Day 28 Post-vaccination
Other Pre-specified Outcome Measures:
Title
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.
Description
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Time Frame
Day 28 Post-vaccination
Title
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.
Description
Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).
Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.
The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.
Time Frame
Day 28 Post-vaccination
Title
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Description
Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).
Time Frame
Day 28 post-vaccination
Title
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Description
Antibodies to polio viruses were measured by a serum neutralization assay.
Time Frame
Day 28 post-vaccination
Title
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Description
Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Time Frame
Days 0 up to 7 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
Available for the duration of the study.
Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
Parent/legal acceptable representative willing and able to provide informed consent.
Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.
Exclusion Criteria:
Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
Previous history of influenza vaccination (Group 2 subjects only).
Receipt of any vaccine in the 14 days prior to enrollment.
An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
Known bleeding disorder.
Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional 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 human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
Known HIV, hepatitis B, or hepatitis C infection.
Receipt of blood or blood-derived products within 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 Monitor
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
27704
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
Seattle
State/Province
Washington
ZIP/Postal Code
98040
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
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