Influenza
Conditions
Keywords
Fluzone®, Influenza Virus Vaccine
Brief summary
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.
Interventions
BIOLOGICALInfluenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0 and Day 28)
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 36 Months
Healthy volunteers
Yes
Inclusion criteria
* Participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday). * Participant is considered to be in good health on the basis of reported medical history and limited physical examination. * Participant is available for the duration of the study. * Parent/legal acceptable representative is willing and able to provide informed consent. * Parent/legal acceptable representative is willing and able to meet protocol requirements. * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
Exclusion criteria
* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * 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 (Enrollment may be deferred). * Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * Participation in any other interventional 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 |
|---|---|---|
| Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Day 14 post-vaccination | GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | 0 to 3 days post-vaccination 1 | Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting. |
| Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | 0 to 3 days post-vaccination 2 | Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting Note: Influenza vaccine-primed group received only dose 1 |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from October to December 2005
Pre-assignment details
A total of 30 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine-naive Group Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively. | 15 |
| Influenza Vaccine-primed Group Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 15 Participants | 15 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 | 19.18 Months STANDARD_DEVIATION 10.24 | 11.92 Months STANDARD_DEVIATION 6.36 | 26.43 Months STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 30 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 17 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 15 | 5 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
Time frame: Day 14 post-vaccination
Population: Geometric Mean Titers were assessed on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New Caledonia/20/99 (H1N1) - Pre | 5.0 Titer |
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New Caledonia/20/99 (H1N1) - Post | 187.8 Titer |
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New York/55/2004 (H3N2) - Pre | 8.5 Titer |
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New York/55/2004 (H3N2) - Post | 328.6 Titer |
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu B/Jiangsu/10/2003 - Pre | 9.2 Titer |
| Influenza Vaccine-naive Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu B/Jiangsu/10/2003 - Post | 59.7 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu B/Jiangsu/10/2003 - Pre | 5.3 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New Caledonia/20/99 (H1N1) - Pre | 8.2 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New York/55/2004 (H3N2) - Post | 249.8 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New Caledonia/20/99 (H1N1) - Post | 95.1 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu B/Jiangsu/10/2003 - Post | 39.0 Titer |
| Influenza Vaccine-primed Group | Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination | Flu A/New York/55/2004 (H3N2) - Pre | 32.8 Titer |
Other Pre-specified
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1
Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.
Time frame: 0 to 3 days post-vaccination 1
Population: Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Solicited Injection Site Reaction post-dose 1 | 3 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Tenderness | 2 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Erythema | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Erythema (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Swelling | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Solicited Systemic Reactions post-dose 1 | 10 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Fever (≥ 100.4°F) | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Fever (> 103.2°F) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Crying abnormal | 4 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Crying abnormal (> 3 hours) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Irritability | 6 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Vomiting (per 24 hours) | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Drowsiness | 6 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Drowsiness (Sleeps most time) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Appetite lost | 4 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Appetite lost (Refuse most feeds) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Drowsiness (Sleeps most time) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Solicited Injection Site Reaction post-dose 1 | 2 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Crying abnormal | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Tenderness | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Crying abnormal (> 3 hours) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Erythema | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Appetite lost (Refuse most feeds) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Erythema (≥ 5.0 cm) | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Irritability | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any injection site Swelling | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Drowsiness | 3 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Solicited Systemic Reactions post-dose 1 | 5 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Appetite lost | 1 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Fever (≥ 100.4°F) | 2 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Any Vomiting (per 24 hours) | 0 Participants |
| Influenza Vaccine-primed Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1 | Grade 3 Fever (> 103.2°F) | 0 Participants |
Other Pre-specified
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2
Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting Note: Influenza vaccine-primed group received only dose 1
Time frame: 0 to 3 days post-vaccination 2
Population: Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any solicited injection site reaction post-dose 2 | 2 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any injection site Tenderness | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any injection site Erythema | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 injection site Erythema (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any injection site Swelling | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any solicited systemic reactions post-dose 2 | 8 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Fever (≥ 100.4 ºF) | 5 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Fever (> 103.2 ºF) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Crying abnormal | 3 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Crying abnormal (> 3 hours) | 1 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Irritability | 5 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Irritability (inconsolable) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Vomiting (per 24 hours) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Drowsiness | 2 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Drowsiness (sleeping most time) | 0 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Any Appetite lost | 3 Participants |
| Influenza Vaccine-naive Group | Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2 | Grade 3 Appetite lost (refuses most feeds) | 0 Participants |