Phase 4
Completed N=200
Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age
Influenza · Healthy
Source: ClinicalTrials.gov NCT03143101 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28 — 10.0; 5.4; 23.4 Percentage of participants — p=0.006
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28 |
10.0; 5.4; 23.4 | 0.006 sig |
| PRIMARY Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28 |
51.7; 64.3; 31.3 | — |
| PRIMARY Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28 |
50.0; 42.9; 57.8 | — |
| PRIMARY Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28 |
14.3; 35.9 | — |
| PRIMARY Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56 |
23.7; 12.5; 45.2 | <0.001 sig |
| PRIMARY Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56 |
54.2; 66.1; 40.3 | — |
| PRIMARY Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56 |
50.0; 53.6; 54.8 | — |
| PRIMARY Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56 |
25.0; 40.3 | — |
| SECONDARY Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR) |
86.7; 81.4; 94.9; 17.2; 25.6; 46.2 | — |
| SECONDARY Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR |
2.2; 2.2; 2.8; 1.2; 1.4; 1.3 | — |
| SECONDARY Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR |
3.79; 3.76; 3.70; 3.66; 3.81; 4.21 | — |
| SECONDARY Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus |
0.0; 10.0; 37.5; 25.0; 3.8; 2.8 | — |
| SECONDARY Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56 |
33.9; 31.7; 40.3; 40.6; 46.7; 67.7 | — |
| SECONDARY Percentage of Participants With Any Post Dose Strain-specific Antibody Response |
10.0; 5.4; 23.4; 3.3; 5.4; 15.9 | — |
| SECONDARY Percentage of Participants With Any Solicited Symptoms |
3.0; 1.5; 10.4; 3.2; 8.2; 6.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
29; 31; 34; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Age 24 months to = 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization
- History of asthma or history of recurrent wheezing
- Any known immunosuppressive condition or immune deficiency disease
- Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination
- Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination
- Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period
- Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- Known or suspected mitochondrial encephalomyopathy
- History of Guillian-Barre syndrome
- Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product
Data sourced from ClinicalTrials.gov (NCT03143101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.