A Phase 4 interventional study of Fluzone® Quadrivalent Influenza Vaccine, No Preservative and Fluzone® Quadrivalent Influenza 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 2015-10-19.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 4, Interventional, and Prevention
The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age.
Objective:
Observational objectives:
Participants will be assigned to the appropriate age group based on the age at the time of enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom 2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose during Visit 2 (28 days after Visit 1).
Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day 28 after the final vaccination.
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.
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Exclusion Criteria:
Participants at 6 months to \< 36 months age at enrollment
Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Participants at 3 years to \< 9 years of age at enrollment
Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
Also known as: Fluzone® Quadrivalent, No Preservative
0.5 mL, Intramuscular (2014-2015 formulation)
Also known as: Fluzone® Quadrivalent, No Preservative
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-any injection
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 28 post-final vaccination
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 28 post-final vaccination
Study participants were enrolled from 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.
| Milestone | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
| Percentage of participants | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| Injection-site Tenderness (N=30, 0) | 70.0 | NA |
| Grade 3 Injection-site Tenderness (N=30, 0) | 3.3 | NA |
| Injection site Pain (N=0, 30) | NA | 73.3 |
| Grade 3 Injection site Pain (N=0, 30) | NA | 10.0 |
| Injection-site Erythema | 50.0 | 66.7 |
| Grade 3 Injection-site Erythema | 0.0 | 0.0 |
| Injection-site Swelling | 23.3 | 43.3 |
| Grade 3 Injection site Swelling (6 to <36 months) | 0.0 | 0.0 |
| Fever | 20.7 | 3.3 |
| Grade 3 Fever | 0.0 | 0.0 |
| Vomiting (N=30, 0) | 16.7 | NA |
| Grade 3 Vomiting (N=30, 0) | 0.0 | NA |
| Crying abnormal (N=30, 0) | 33.3 | NA |
| Grade 3 Crying abnormal (N=30, 0) | 0.0 | NA |
| Drowsiness (N=30, 0) | 30.0 | NA |
| Grade 3 Drowsiness (N=30, 0) | 0.0 | NA |
| Appetite lost (N=30, 0) | 26.7 | NA |
| Grade 3 Appetite lost | 0.0 | NA |
| Irritability (N=30, 0) | 53.3 | NA |
| Grade 3 Irritability (N=30, 0) | 0.0 | NA |
| Headache (N=0, 30) | NA | 10.0 |
| Grade 3 Headache (N=0, 30) | NA | 0.0 |
| Malaise (N=0, 30) | NA | 13.3 |
| Grade 3 Malaise (N=0, 30) | NA | 0.0 |
| Myalgia (N=0, 30) | NA | 13.3 |
| Grade 3 Myalgia (N=0, 30) | NA | 0.0 |
Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
| Titers (1/dilutions) | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| A/H1N1; Pre-vaccination | 32.6 (16.4 to 64.9) | 361 (179 to 727) |
| A/H1N1; Post-vaccination | 447 (254 to 787) | 1235 (793 to 1924) |
| A/H3N2; Pre-vaccination | 55.9 (25.7 to 121) | 277 (162 to 473) |
| A/H3N2; Post-vaccination | 696 (416 to 1165) | 1250 (861 to 1814) |
| B (Yamagata); Pre-vaccination | 56.6 (30.3 to 106) | 281 (158 to 497) |
| B (Yamagata); Post-vaccination | 617 (342 to 1115) | 1425 (972 to 2090) |
| B (Victoria); Pre-vaccination | 12.5 (6.88 to 22.9) | 156 (85.9 to 284) |
| B (Victoria); Post-vaccination | 352 (203 to 612) | 1136 (706 to 1828) |
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
| Percentage of participants | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| A/H1N1; Pre-vaccination | 44.8 | 86.2 |
| A/H1N1; Post-vaccination | 93.1 | 96.6 |
| A/H3N2; Pre-vaccination | 62.1 | 93.1 |
| A/H3N2; Post-vaccination | 96.6 | 100.0 |
| B (Yamagata); Pre-vaccination | 55.2 | 89.7 |
| B (Yamagata); Post-vaccination | 100.0 | 100.0 |
| B (Victoria); Pre-vaccination | 17.2 | 82.8 |
| B (Victoria); Post-vaccination | 100.0 | 100.0 |
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
| Percentage of participants | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| A/H1N1 | 86.2 | 34.5 |
| A/H3N2 | 89.7 | 58.6 |
| B (Yamagata) | 86.2 | 58.6 |
| B (Victoria) | 89.7 | 69.0 |
Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
| Titer ratio | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| A/H1N1 | 10.9 (6.61 to 18.0) | 3.30 (2.14 to 5.11) |
| A/H3N2 | 10.4 (6.59 to 16.4) | 4.51 (3.09 to 6.58) |
| B (Yamagata) | 10.0 (6.35 to 15.9) | 5.02 (3.43 to 7.34) |
| B (Victoria) | 18.9 (11.6 to 30.8) | 7.10 (4.71 to 10.7) |
Collected over Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 6 to < 36 Months of Age | — | 1/30 (3.3%) | 21/30 (70%) |
| 3 to < 9 Years of Age | — | 0/30 (0%) | 22/30 (73.3%) |
| Event | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| Abscess neckInfections and infestations | 1/30 | 0/30 |
| Event | 6 to < 36 Months of Age | 3 to < 9 Years of Age |
|---|---|---|
| Injection site PainGeneral disorders | 0/30 | 22/30 |
| Injection site TendernessGeneral disorders | 21/30 | 0/30 |
| Injection site ErythemaGeneral disorders | 15/30 | 20/30 |
| IrritabilityPsychiatric disorders | 16/30 | 0/30 |
| Injection site SwellingGeneral disorders | 7/30 | 13/30 |
| Crying abnormalPsychiatric disorders | 10/30 | 0/30 |
| DrowsinessNervous system disorders | 9/30 | 0/30 |
| Appetite lostMetabolism and nutrition disorders | 8/30 | 0/30 |
| FeverGeneral disorders | 6/29 | 1/30 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/30 | 5/30 |
| Age, Categorical(Participants) | 6 to < 36 Months of Age | 3 to < 9 Years of Age | Total |
|---|---|---|---|
| <=18 years | 30 | 30 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | 6 to < 36 Months of Age | 3 to < 9 Years of Age | Total |
|---|---|---|---|
| Age Continuous | 25.0 ± 8.3 | 66.9 ± 21.8 | 45.9 ± 26.7 |
| Sex: Female, Male(Participants) | 6 to < 36 Months of Age | 3 to < 9 Years of Age | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 15 | 13 | 28 |
| Region of Enrollment(Participants) | 6 to < 36 Months of Age | 3 to < 9 Years of Age | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
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Sanofi Pasteur, a Sanofi Company