Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885105
• Other study ID #: GRC32
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2009
• Last updated: April 12, 2016
• Start date: October 2005
• Est. completion date: September 2007

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2007
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 11 Months

Eligibility

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.

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

Intervention

Biological:
• Influenza Virus Vaccine
0.25 mL, Intramuscular
• Influenza Virus Vaccine
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	Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.	Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.	Day 28 Post-vaccination	No
Other	Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.	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.	Day 28 Post-vaccination	No
Other	Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.	Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).	Day 28 post-vaccination	No
Other	Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.	Antibodies to polio viruses were measured by a serum neutralization assay.	Day 28 post-vaccination	No
Other	Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.	Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.	Days 0 up to 7 post-vaccination	Yes
Primary	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.	Day 28 Post-vaccination	No

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