A Phase 4 interventional study of Influenza Virus Vaccine (Fluzone®) and Influenza Virus Vaccine (Fluzone®) in Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in United States. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 4, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 30 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.
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Exclusion Criteria:
Subjects have never received Influenza virus vaccine in the past
Biological: Influenza Virus Vaccine (Fluzone®)
Subjects have received Influenza virus vaccine in the past
Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0 and Day 28)
Also known as: Fluzone®
0.25 mL, Intramuscular (Day 0)
Also known as: Fluzone®
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
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
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
Subjects were enrolled from October to December 2005
| Milestone | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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)
| Titer | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|
| Flu A/New Caledonia/20/99 (H1N1) - Pre | 5.0 (5.0 to 5.0) | 8.2 (4.3 to 15.6) |
| Flu A/New Caledonia/20/99 (H1N1) - Post | 187.8 (105.4 to 334.5) | 95.1 (44.0 to 205.9) |
| Flu A/New York/55/2004 (H3N2) - Pre | 8.5 (4.9 to 14.7) | 32.8 (10.9 to 98.4) |
| Flu A/New York/55/2004 (H3N2) - Post | 328.6 (181.2 to 596.0) | 249.8 (88.1 to 708.6) |
| Flu B/Jiangsu/10/2003 - Pre | 9.2 (4.6 to 18.7) | 5.3 (4.7 to 5.8) |
| Flu B/Jiangsu/10/2003 - Post | 59.7 (22.7 to 156.9) | 39.0 (17.2 to 88.7) |
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.
| Participants | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|
| Any Solicited Injection Site Reaction post-dose 1 | 3 | 2 |
| Any injection site Tenderness | 2 | 1 |
| Grade 3 injection site Tenderness-reduced movement | 0 | 0 |
| Any injection site Erythema | 1 | 1 |
| Grade 3 injection site Erythema (≥ 5.0 cm) | 0 | 1 |
| Any injection site Swelling | 1 | 1 |
| Grade 3 injection site Swelling (≥ 5.0 cm) | 0 | 0 |
| Any Solicited Systemic Reactions post-dose 1 | 10 | 5 |
| Any Fever (≥ 100.4°F) | 1 | 2 |
| Grade 3 Fever (> 103.2°F) | 0 | 0 |
| Any Crying abnormal | 4 | 1 |
| Grade 3 Crying abnormal (> 3 hours) | 0 | 0 |
| Any Irritability | 6 | 1 |
| Grade 3 Irritability (Inconsolable) | 0 | 0 |
| Any Vomiting (per 24 hours) | 1 | 0 |
| Grade 3 Vomiting (≥ 6 episodes) | 0 | 0 |
| Any Drowsiness | 6 | 3 |
| Grade 3 Drowsiness (Sleeps most time) | 0 | 0 |
| Any Appetite lost | 4 | 1 |
| Grade 3 Appetite lost (Refuse most feeds) | 0 | 0 |
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
| Participants | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|
| Any solicited injection site reaction post-dose 2 | 2 | — |
| Any injection site Tenderness | 1 | — |
| Grade 3 injection site Tenderness-reduced movement | 0 | — |
| Any injection site Erythema | 0 | — |
| Grade 3 injection site Erythema (≥ 5.0 cm) | 0 | — |
| Any injection site Swelling | 1 | — |
| Grade 3 injection site Swelling (≥ 5.0 cm) | 0 | — |
| Any solicited systemic reactions post-dose 2 | 8 | — |
| Any Fever (≥ 100.4 ºF) | 5 | — |
| Grade 3 Fever (> 103.2 ºF) | 0 | — |
| Any Crying abnormal | 3 | — |
| Grade 3 Crying abnormal (> 3 hours) | 1 | — |
| Any Irritability | 5 | — |
| Grade 3 Irritability (inconsolable) | 0 | — |
| Any Vomiting (per 24 hours) | 0 | — |
| Grade 3 Vomiting (≥ 6 episodes) | 0 | — |
| Any Drowsiness | 2 | — |
| Grade 3 Drowsiness (sleeping most time) | 0 | — |
| Any Appetite lost | 3 | — |
| Grade 3 Appetite lost (refuses most feeds) | 0 | — |
Collected over Adverse events data were collected from day of vaccination for 2 weeks (Influenza vaccine-Primed) and 6 weeks (Influenza vaccine naive) participants.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Influenza Vaccine-naive Group | — | 0/15 (0%) | 13/15 (86.7%) |
| Influenza Vaccine-primed Group | — | 0/15 (0%) | 5/15 (33.3%) |
| Event | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group |
|---|---|---|
| IrritabilityPsychiatric disorders | 8/15 | 1/15 |
| PyrexiaGeneral disorders | 6/15 | 2/15 |
| SomnolenceNervous system disorders | 6/15 | 3/15 |
| AnorexiaMetabolism and nutrition disorders | 6/15 | 1/15 |
| CryingPsychiatric disorders | 5/15 | 1/15 |
| Injection site tendernessGeneral disorders | 3/15 | 1/15 |
| PyrexiaGeneral disorders | 3/15 | 0/15 |
| Upper respiratory tract infectionInfections and infestations | 3/15 | 0/15 |
| Injection site erythemaGeneral disorders | 1/15 | 1/15 |
| Injection site swellingGeneral disorders | 1/15 | 1/15 |
| Age, Categorical(Participants) | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group | Total |
|---|---|---|---|
| <=18 years | 15 | 15 | 30 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group | Total |
|---|---|---|---|
| Mean | 11.92 ± 6.36 | 26.43 ± 8.00 | 19.18 ± 10.24 |
| Sex: Female, Male(Participants) | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group | Total |
|---|---|---|---|
| Female | 10 | 7 | 17 |
| Male | 5 | 8 | 13 |
| Region of Enrollment(participants) | Influenza Vaccine-naive Group | Influenza Vaccine-primed Group | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company