Trial · NCT00860067
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
NCT00860067, Phase 2, Phase 3, Completed, MedImmune LLC; results first posted 2011-08-12
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ConductScience Library. A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age. Trials, record NCT00860067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00860067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
- NCT number
- NCT00860067
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,800 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Healthy or Stable Underlying Chronic Medical Condition
- Interventions
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
- First posted
- 2009-03-11
- Last updated
- 2011-12-05
- Results first posted
- 2011-08-12
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 28-35 | 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 Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. | Day 0 and Day 28-35 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \<= 8 were considered to be serosusceptible for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \<= 8 were considered to be serosusceptible for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \<= 8 were considered to be serosusceptible for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \<= 8 were considered to be serosusceptible for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
| 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 | Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer \> 8 were considered to be seropositive for that strain. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Q/LAIV (MEDI3250) | A/H1N1 | 5.9 | Full Range 2 to 1024 | geometric mean titer |
| 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. | FluMist/B/Yamagata | A/H1N1 | NA | Full Range NA to NA | geometric mean titer |
| 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. | FluMist/B/Victoria | A/H1N1 | NA | Full Range NA to NA | geometric mean titer |
| 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. | All FluMist | A/H1N1 | 6.5 | Full Range 2 to 512 | geometric mean titer |
| 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. | Q/LAIV (MEDI3250) | A/H3N2 | 7.5 | Full Range 2 to 2896 | geometric mean titer |
| 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. | FluMist/B/Yamagata | A/H3N2 | NA | Full Range NA to NA | geometric mean titer |
| 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. | FluMist/B/Victoria | A/H3N2 | NA | Full Range NA to NA | geometric mean titer |
| 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. | All FluMist | A/H3N2 | 7.8 | Full Range 2 to 2048 | geometric mean titer |
| 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. | Q/LAIV (MEDI3250) | B/Yamagata | 51.2 | Full Range 2 to 2048 | geometric mean titer |
| 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. | FluMist/B/Yamagata | B/Yamagata | 56.4 | Full Range 2 to 2048 | geometric mean titer |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Q/LAIV (MEDI3250) | 1,200 | |
| Overall Study | STARTED | FluMist/B/Yamagata | 299 | |
| Overall Study | STARTED | FluMist/B/Victoria | 301 | |
| Overall Study | COMPLETED | Q/LAIV (MEDI3250) | 1,149 | |
| Overall Study | COMPLETED | FluMist/B/Yamagata | 290 | |
| Overall Study | COMPLETED | FluMist/B/Victoria | 292 | |
| Overall Study | NOT COMPLETED | Q/LAIV (MEDI3250) | 51 | |
| Overall Study | NOT COMPLETED | FluMist/B/Yamagata | 9 | |
| Overall Study | NOT COMPLETED | FluMist/B/Victoria | 9 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DIARRHOEA | Gastrointestinal disorders | Q/LAIV (MEDI3250) | 10 | 1,198 | 10 |
| other | DIARRHOEA | Gastrointestinal disorders | All FluMist | 6 | 598 | 7 |
| other | NAUSEA | Gastrointestinal disorders | Q/LAIV (MEDI3250) | 11 | 1,198 | 11 |
| other | NAUSEA | Gastrointestinal disorders | All FluMist | 6 | 598 | 6 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Q/LAIV (MEDI3250) | 14 | 1,198 | 14 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | All FluMist | 8 | 598 | 8 |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | Q/LAIV (MEDI3250) | 3 | 1,198 | 3 |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | All FluMist | 6 | 598 | 6 |
| other | HEADACHE | Nervous system disorders | Q/LAIV (MEDI3250) | 9 | 1,198 | 9 |
| other | HEADACHE | Nervous system disorders | All FluMist | 7 | 598 | 7 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Q/LAIV (MEDI3250) | ||
| Total, all-cause mortality | All FluMist | ||
| Total, other adverse events | Q/LAIV (MEDI3250) | 102 | 1,198 |
| Total, other adverse events | All FluMist | 57 | 598 |
| Total, serious adverse events | Q/LAIV (MEDI3250) | 12 | 1,198 |
| Total, serious adverse events | All FluMist | 6 | 598 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21983154 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons21
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Q/LAIV (MEDI3250) vs FluMist/B/Victoria: The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs All FluMist: Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Yamagata: The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Victoria: The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Victoria: The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Victoria: The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Yamagata: The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs FluMist/B/Yamagata: The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose. | Trial comparisons |
| Q/LAIV (MEDI3250) vs All FluMist: Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination | Trial comparisons |
| Q/LAIV (MEDI3250) vs All FluMist: The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose. | Trial comparisons |
1 to 10 of 21
See all 21 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00860067
GET https://conductscience.org/api/trials/v1/NCT00860067/registered?page=2