Influenza
Conditions
Keywords
Influenza, Fluzone®, Children
Brief summary
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months
Detailed description
The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
Interventions
BIOLOGICALInfluenza virus vaccine (Pediatric formulation)
0.25 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
: * Aged ≥ 6 months to \< 36 months. * Considered to be in good health on the basis of reported medical history and limited physical examination. * Available for the duration of the study (44 days +4 days). * Parent/guardian is willing and able to provide informed consent. * Parent/guardian is willing and able to meet protocol requirements.
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. * An acute illness with or without fever (temperature \> 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment). * Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Day 0 to 3 post-vaccination | Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | Day 0 and Day 14 after Dose 2 | Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination. |
| Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) | Day 0 and Day 14 Post-dose 2 | Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 11 through 25 September 2003 in 1 US site.
Pre-assignment details
A total of 33 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Study Group Participants received study vaccine on Days 0 and 30. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 33 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous Age Continuous | 19.08 Months STANDARD_DEVIATION 9.69 |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Time frame: Day 0 to 3 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Local Reaction Post-Dose 1 | 9 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Redness (> 5 mm) | 6 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Redness (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Induration (> 5 mm) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Induration (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Bruising (> 5 mm) | 3 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Induration (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Bruising (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Pain | 7 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Pain (Cries when leg or arm is moved) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Local Reaction Post-Dose 2 | 12 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Redness (> 5 mm) | 6 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Redness (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Induration (> 5 mm) | 5 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Bruising (> 5 mm) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Bruising (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Pain | 9 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Pain (Cries when leg or arm is moved) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Local Reaction Post-Any Dose | 14 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Redness (> 5 mm) | 8 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Redness (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Induration (> 5 mm) | 5 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Induration (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Bruising (> 5 mm) | 5 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Bruising (> 50 mm) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Pain | 10 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Pain (Cries when leg or arm is moved) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Systemic Reaction Post-Dose 1 | 19 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Fever (Rectal Temp) | 6 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Fever (> 103.1 ºF) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Irritability | 10 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Irritability (> 3 hours) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Crying | 11 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Crying (inconsolable for > 3 hours) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Lethargy | 9 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Lethargy (Uninterested in usual activity) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Appetite Decreased | 11 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Vomiting | 3 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Vomiting ( ≥ 3 episodes) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Diarrhea | 6 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Diarrhea ( > 5 diarrhea stools/day) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Rash - Presence of Welts | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Systemic Reaction Post-Dose 2 | 14 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Fever (Rectal Temp) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Fever (> 103.1 ºF) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Irritability | 12 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Irritability (> 3 hours) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Crying | 7 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Crying (inconsolable for > 3 hours) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Lethargy | 7 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Lethargy (Uninterested in usual activity) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Appetite Decreased | 8 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Vomiting | 3 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Vomiting ( ≥ 3 episodes) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Diarrhea | 4 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Diarrhea (> 5 diarrhea stools/day) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Rash - Presence of Welts | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Solicited Systemic Reaction Post-Any Dose | 22 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Fever | 7 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Fever (> 103.1 ºF) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Irritability | 15 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Irritability (> 3 hours) | 2 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Crying | 12 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Crying (inconsolable for > 3 hours) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Lethargy | 11 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Lethargy (Uninterested in usual activity) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Appetite Decreased | 14 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Vomiting | 4 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Vomiting (≥ 3 episodes) | 1 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Any Diarrhea | 7 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Grade 3 Diarrhea (> 5 diarrhea stools/day) | 0 Participants |
| Study Group | Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination | Rash - Presence of Welts | 1 Participants |
Other Pre-specified
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)
Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
Time frame: Day 0 and Day 14 Post-dose 2
Population: Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) | A/Panama (H3N2) | 84 Percentage of Participants |
| Study Group | Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) | A/New Caledonia (H1N1) | 94 Percentage of Participants |
| Study Group | Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion) | B/Hong Kong | 81 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)
Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
Time frame: Day 0 and Day 14 after Dose 2
Population: Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | A/Panama (H3N2) Pre-vaccination | 10 Percentage of Participants |
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | A/Panama (H3N2) Post-dose 2 | 77 Percentage of Participants |
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | A/New Caledonia (H1N1) Pre-vaccination | 10 Percentage of Participants |
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | A/New Caledonia (H1N1) Post-dose 2 | 81 Percentage of Participants |
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | B/Hong Kong Pre-vaccination | 0 Percentage of Participants |
| Study Group | Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection) | B/Hong Kong Post-dose 2 | 48 Percentage of Participants |