Trial · NCT01091246
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
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 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464; FV=463; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445; FV=437; All FM=883). | Geometric mean titer | GEOMETRIC_MEAN |
| SECONDARY | The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1320; All FM=878). | percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; All FM=879). | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FY=441). | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FV=437). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191). | Percent of participants | NUMBER |
| SECONDARY | Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=460; All FM=321). | Percent of participants | NUMBER |
| SECONDARY | Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=364; All FM=244). | Percent of participants | NUMBER |
| SECONDARY | Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165). | Percent of participants | NUMBER |
| SECONDARY | Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose | Day 0 and Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159). | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; All FM=883). | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445). | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FV=437). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192). | Percent of participants | NUMBER |
| SECONDARY | Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191). | Percent of 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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