Trial · NCT01091246
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. . |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise from baseline. |
| 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 | Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | |
| Secondary | Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | |
| Secondary | Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | |
| Secondary | Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | Serosusceptible was defined as a baseline HAI titer ≤ 8. |
| Secondary | Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | Serosusceptible was defined as a baseline HAI titer ≤ 8. |
| Secondary | Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | Serosusceptible was defined as a baseline HAI titer ≤ 8. |
| Secondary | Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose | Day 28 post immunogenicity dose | Serosusceptible was defined as a baseline HAI titer ≤ 8. |
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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