A Phase 4 interventional study of Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose and Fluzone®; Influenza Virus Vaccine, No Preservative in Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 sites in United States. Open to participants aged 6 Months to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-16.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 4, Interventional, and Prevention
The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.
Objective:
Observational Objectives:
All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be administered during Visit 2.
Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 60 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants at 6 months to \< 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).
Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
Participants at 3 years to \< 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.
Biological: Fluzone®; Influenza Virus Vaccine, No Preservative
0.25 mL dose, Intramuscular
Also known as: Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation
0.5 mL dose, Intramuscular
Also known as: Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Solicited injection site reactions (Age 6 to \< 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, \>103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, \>3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions (Age 24 Months to \< 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.
Time frame: Day 28 after final vaccination
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
The study participants were enrolled from 19 September 2012 to 12 December 2012 at 2 clinic centers in the United States.
| Milestone | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
Solicited injection site reactions (Age 6 to \< 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, \>103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, \>3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable. Solicited injection site reactions (Age 24 Months to \< 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
| Participants | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group |
|---|---|---|
| Injection site Tenderness (N = 15, 0) | 8 | NA (0 to 0) |
| Grade 3 Injection site Tenderness (N =15, 0) | 1 | NA (0 to 0) |
| Injection site Pain (N =15, 30) | 8 | 13 (0 to 0) |
| Grade 3 Injection site Pain (N = 15, 30) | 0 | 0 (0 to 0) |
| Injection site Erythema (N = 30, 30) | 8 | 9 (0 to 0) |
| Grade 3 Injection site Erythema (N = 30, 30) | 0 | 0 (0 to 0) |
| Injection site Swelling (N = 30, 30) | 5 | 7 (0 to 0) |
| Grade 3 Injection site Swelling (N = 30, 30) | 0 | 0 (0 to 0) |
| Fever (N = 30, 28) | 2 | 0 (0 to 0) |
| Grade 3 Fever (N = 30, 28) | 0 | 0 (0 to 0) |
| Headache (N = 15, 30) | 1 | 5 (0 to 0) |
| Grade 3 Headache (N = 15, 30) | 0 | 0 (0 to 0) |
| Malaise (N = 15, 30) | 4 | 4 (0 to 0) |
| Grade 3 Malaise (N = 15, 30) | 0 | 0 (0 to 0) |
| Myalgia (N = 15, 30) | 3 | 2 (0 to 0) |
| Grade 3 Myalgia (N = 15, 30) | 0 | 0 (0 to 0) |
| Vomiting (N = 15, 0) | 1 | NA (0 to 0) |
| Grade 3 Vomiting (N = 15, 0) | 0 | NA (0 to 0) |
| Abnormal crying (N = 15, 0) | 6 | NA (0 to 0) |
| Grade 3 Abnormal crying (N = 15, 0) | 0 | NA (0 to 0) |
| Drowsiness (N = 15, 0) | 5 | NA (0 to 0) |
| Grade 3 Drowsiness (N = 15, 0) | 0 | NA (0 to 0) |
| Loss of Appetite (N = 15, 0) | 4 | NA (0 to 0) |
| Grade 3 Loss of Appetite (N = 15, 0) | 0 | NA (0 to 0) |
| Irritability (N = 15, 0) | 9 | NA (0 to 0) |
| Grade 3 Irritability (N = 15, 0) | 1 | NA (0 to 0) |
The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
| Titers | 6 to < 36 Months Age Group | 3 to < 9 Years Age Group |
|---|---|---|
| A/H1N1 (pre-vaccination) | 20.6 (9.93 to 42.6) | 68.8 (30.5 to 155) |
| A/H1N1 (post-vaccination) | 334 (189 to 589) | 864 (559 to 1337) |
| A/H3N2 (pre-vaccination) | 23.3 (11.4 to 47.5) | 84.8 (49.5 to 145) |
| A/H3N2 (post-vaccination) | 506 (296 to 865) | 895 (585 to 1369) |
| B (pre-vaccination) | 5.82 (4.76 to 7.13) | 9.66 (7.42 to 12.6) |
| B (post-vaccination) | 16.7 (11.2 to 24.8) | 69.6 (46.4 to 105) |
Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).
| Participants | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group |
|---|---|---|
| A/H1N1 (pre-vaccination) | 10 | 18 (0 to 0) |
| A/H1N1 (post-vaccination) | 24 | 30 (0 to 0) |
| A/H3N2 (pre-vaccination) | 11 | 20 (0 to 0) |
| A/H3N2 (post-vaccination) | 25 | 30 (0 to 0) |
| B (pre-vaccination) | 1 | 2 (0 to 0) |
| B (post-vaccination) | 6 | 21 (0 to 0) |
Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.
| Participants | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group |
|---|---|---|
| A/H1N1 | 22 | 22 (0 to 0) |
| A/H3N2 | 23 | 25 (0 to 0) |
| B | 5 | 20 (0 to 0) |
Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens
| Ratio | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group |
|---|---|---|
| A/H1N1 | 11.6 (7.24 to 18.7) | 10.7 (5.56 to 20.5) |
| A/H3N2 | 16.2 (9.45 to 27.9) | 10.3 (5.88 to 18.1) |
| B | 1.82 (1.29 to 2.55) | 5.34 (3.75 to 7.60) |
Collected over Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 after final vaccination.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 6 to < 36 Months Age Group | — | 0/30 (0%) | 9/30 (30%) |
| 3 to < 9 Years Age Group | — | 0/30 (0%) | 13/30 (43.3%) |
| Event | 6 to < 36 Months Age Group | 3 to < 9 Years Age Group |
|---|---|---|
| IrritabilityPsychiatric disorders | 9/15 | — |
| Injection site TendernessGeneral disorders | 8/15 | — |
| Injection site PainGeneral disorders | 8/15 | 13/30 |
| Abnormal cryingPsychiatric disorders | 6/15 | — |
| DrowsinessNervous system disorders | 5/15 | — |
| Injection site ErythemaGeneral disorders | 8/30 | 9/30 |
| Loss of AppetiteMetabolism and nutrition disorders | 4/15 | — |
| MalaiseGeneral disorders | 4/15 | 4/30 |
| Injection site SwellingGeneral disorders | 5/30 | 7/30 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/15 | 2/30 |
| Age, Categorical(Participants) | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group | Total |
|---|---|---|---|
| <=18 years | 30 | 30 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group | Total |
|---|---|---|---|
| Mean | 1.8 ± 0.6 | 5.2 ± 1.6 | 3.5 ± 1.2 |
| Sex: Female, Male(Participants) | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 16 | 17 | 33 |
| Region of Enrollment(Participants) | Age 6 to < 36 Months Group | Age 3 to < 9 Years Group | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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Sanofi Pasteur, a Sanofi Company