Influenza, Orthomyxoviridae Infections
Conditions
Keywords
Influenza, Orthomyxoviruses, Orthomyxoviridae Infections, Influenza vaccine
Brief 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.
Detailed 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).
Interventions
BIOLOGICALInfluenza Virus Vaccine No Preservative: Pediatric Dose
0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Day 0 to Day 3 post-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. |
| Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Day 0 to Day 3 post-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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | Day 28 post-single dose or Day 21 post-Dose 2 | 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. |
| Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | Day 28 post-single dose or Day 21 post-Dose 2 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 15 September to 1 October 2008 in 1 clinical center in the US.
Pre-assignment details
A total of 32 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Primed Group Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | 24 |
| Naive/Inadequately Primed Group Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Naive/Inadequately Primed Group | Primed Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 24 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 22.1 Months STANDARD_DEVIATION 10.36 | 32.8 Months STANDARD_DEVIATION 10.52 | 30.1 Months STANDARD_DEVIATION 11.34 |
| Region of Enrollment United States | 8 participants | 24 participants | 32 participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 24 | 4 / 8 |
| serious Total, serious adverse events | 0 / 24 | 0 / 8 |
Outcome results
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.
Time frame: Day 0 to Day 3 post-vaccination 1
Population: Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Vomiting | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Erythema | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Vomiting (≥ 6 Episodes per 24 hours) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Irritability | 2 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Crying Abnormal | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Crying Abnormal (> 3 hours) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Tenderness (Cries When Limb Is Moved) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Drowsiness | 4 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Swelling | 1 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Drowsiness (Sleeps most of time) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Solicited Injection Site Reaction | 10 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Pain | 8 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Headache | 1 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Solicited Systemic Reaction | 12 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Appetite Lost | 1 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Malaise | 4 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Fever | 2 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Myalgia | 6 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Fever (> 103.1 ºF) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Tenderness | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Appetite Lost | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Solicited Injection Site Reaction | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Tenderness | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Tenderness (Cries When Limb Is Moved) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Pain | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Erythema | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Erythema (≥ 5 cm) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Swelling | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Swelling (≥ 5 cm) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Solicited Systemic Reaction | 4 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Fever | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Fever (> 103.1 ºF) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Vomiting | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Vomiting (≥ 6 Episodes per 24 hours) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Crying Abnormal | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Crying Abnormal (> 3 hours) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Drowsiness | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Irritability | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Headache | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Malaise | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Any Myalgia | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Grade 3 Drowsiness (Sleeps most of time) | 0 Participants |
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.
Time frame: Day 0 to Day 3 post-vaccination 2
Population: Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Solicited injection site reaction | 3 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Tenderness | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Tenderness (Cries when limb is moved) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Pain | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Pain (Incapacitating) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Erythema | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Erythema (≥ 5cm) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Swelling | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Swelling (≥ 5cm) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Solicited Systemic Reaction | 4 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Fever | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Fever (> 103.1 ºF) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Vomiting | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Vomiting (≥ 6 Episode per 24 hour) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Crying Abnormal | 2 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Crying Abnormal (> 3 hours) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Drowsiness | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Drowsiness (Sleeps most of the time) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Appetite Lost | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Irritability | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Headache | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Malaise | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Any Myalgia | 1 Participants |
| Naive/Inadequately Primed Group | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, All | 54.8 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Pre, All | 24.5 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Pre, All | 5.3 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, 6-35 mo | 46.5 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Pre, 6-35 mo | 17.9 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Pre, 6-35 mo | 5.2 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, All | 320.0 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Post, All | 510.5 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Post, All | 26.2 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, 6-35 mo | 320.0 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Post, 6-35 mo | 424.1 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Post, 6-35 mo | 18.3 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Post, 6-35 mo | 226.3 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, All | 8.6 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, All | 168.1 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Pre, All | 10.5 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, 6-35 mo | 168.1 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Pre, All | 5.0 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Post, All | 226.3 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, 6-35 mo | 8.6 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Post, 6-35 mo | 31.2 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/X175-C Pre, 6-35 mo | 10.5 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Post, All | 31.2 Titers |
| Naive/Inadequately Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006 Pre, 6-35 mo | 5.0 Titers |
Other Pre-specified
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148, Pre 36-59 mo | 84.8 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/ X175-C, Pre 36-59 mo | 56.6 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006, Pre 36-59 mo | 5.6 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H1N1 Flu A/Brisbane/59/2007 IVR-148, Post 36-59 mo | 320.0 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | H3N2 Flu A/Uruguay/716/2007/ X175-C, Post 36-59 mo | 780.2 Titers |
| Primed Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | B Flu B/Florida/04/2006, Post 36-59 mo | 59.4 Titers |
Other Pre-specified
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.
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo | 50 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H3N2 Flu A/Uruguay/716/2007/X-175-C, 36-59 mo | 83 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | B Flu B/Florida/04/2006, 36-59 mo | 67 Percentage of participants |
Other Pre-specified
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.
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H3N2 Flu A/Uruguay/716/2007/X175-C - All | 91 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo | 50 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - All | 50 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | B Flu B/Florida/04/2006 - All | 41 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | B Flu B/Florida/04/2006 - 6-35 mo | 31 Percentage of participants |
| Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo | 94 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | B Flu B/Florida/04/2006 - 6-35 mo | 71 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - All | 86 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H3N2 Flu A/Uruguay/716/2007/X175-C - All | 86 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | B Flu B/Florida/04/2006 - All | 71 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo | 86 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo | 86 Percentage of participants |
Other Pre-specified
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.
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Seroprotection post-vaccination were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - All | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H3N2 Flu A/Uruguay/716/2007/X175-C - All | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | B Flu B/Florida/04/2006 - All | 44 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | B Flu B/Florida/04/2006 - 6-35 mo | 31 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo | 86 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - All | 100 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo | 100 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H3N2 Flu A/Uruguay/716/2007/X175-C - All | 86 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | B Flu B/Florida/04/2006 - 6-35 mo | 71 Percentage of participants |
| Naive/Inadequately Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | B Flu B/Florida/04/2006 - All | 71 Percentage of participants |
Other Pre-specified
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.
Time frame: Day 28 post-single dose or Day 21 post-Dose 2
Population: Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | H3N2 Flu A/Uruguay/716/2007/ X175-C, 36-59 mo | 100 Percentage of participants |
| Primed Group | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | B Flu B/Florida/04/2006, 36-59 mo | 71 Percentage of participants |