Trial · NCT00860067
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589). | geometric mean titer | GEOMETRIC_MEAN |
| SECONDARY | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231). | participants | NUMBER |
| SECONDARY | The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43). | participants | NUMBER |
| SECONDARY | The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249). | participants | NUMBER |
| SECONDARY | The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Day 28-35 | Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231). | participants | NUMBER |
| SECONDARY | The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination | Days 0-14 | The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597). | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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