Trial · NCT01091246
A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
NCT01091246, Phase 3, Completed, MedImmune LLC; results first posted 2011-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children. Trials, record NCT01091246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01091246
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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 Live Attenuated Influenza Vaccine (LAIV) in Children
- NCT number
- NCT01091246
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,312 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Healthy or Stable Chronic Illness
- Interventions
- Q/LAIV (MEDI3250), FluMist/B/Yamagata, FluMist/B/Victoria
- First posted
- 2010-03-23
- Last updated
- 2011-09-26
- Results first posted
- 2011-09-22
Source ClinicalTrials.gov
Registered outcomes34
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 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. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
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 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 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group162
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 | 16.7 | Full Range 15.9 to 17.6 | 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 Group | A/H1N1 | 17.9 | Full Range 16.8 to 19.1 | 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 | 27.7 | Full Range 26.1 to 29.4 | 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 Group | A/H3N2 | 28.8 | Full Range 26.7 to 31.1 | 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 | 49.6 | Full Range 46.6 to 52.8 | 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 | 59.8 | Full Range 53.7 to 66.7 | Geometric mean titer |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 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) | 1,385 | |
| Overall Study | STARTED | FluMist/B/Yamagata | 464 | |
| Overall Study | STARTED | FluMist/B/Victoria | 463 | |
| Overall Study | COMPLETED | Q/LAIV (MEDI3250) | 1,350 | |
| Overall Study | COMPLETED | FluMist/B/Yamagata | 448 | |
| Overall Study | COMPLETED | FluMist/B/Victoria | 450 | |
| Overall Study | NOT COMPLETED | Q/LAIV (MEDI3250) | 35 | |
| Overall Study | NOT COMPLETED | FluMist/B/Yamagata | 16 | |
| Overall Study | NOT COMPLETED | FluMist/B/Victoria | 13 |
Source ClinicalTrials.gov
Adverse events48
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 | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Q/LAIV (MEDI3250) | 10 | 1,382 | 12 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | All FluMist Group | 12 | 923 | 14 |
| other | DIARRHOEA | Gastrointestinal disorders | Q/LAIV (MEDI3250) | 22 | 1,382 | 22 |
| other | DIARRHOEA | Gastrointestinal disorders | All FluMist Group | 19 | 923 | 19 |
| other | VOMITING | Gastrointestinal disorders | Q/LAIV (MEDI3250) | 36 | 1,382 | 37 |
| other | VOMITING | Gastrointestinal disorders | All FluMist Group | 20 | 923 | 21 |
| other | PYREXIA | General disorders | Q/LAIV (MEDI3250) | 23 | 1,382 | 23 |
| other | PYREXIA | General disorders | All FluMist Group | 6 | 923 | 8 |
| other | OTITIS MEDIA | Infections and infestations | Q/LAIV (MEDI3250) | 12 | 1,382 | 12 |
| other | OTITIS MEDIA | Infections and infestations | All FluMist Group | 12 | 923 | 12 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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 Group | ||
| Total, other adverse events | Q/LAIV (MEDI3250) | 176 | 1,382 |
| Total, other adverse events | All FluMist Group | 105 | 923 |
| Total, serious adverse events | Q/LAIV (MEDI3250) | 6 | 1,382 |
| Total, serious adverse events | All FluMist Group | 5 | 923 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Q/LAIV (MEDI3250) vs All FluMist Group: serious adverse events |
Source Trial comparisons
Tests0
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/NCT01091246
GET https://conductscience.org/api/trials/v1/NCT01091246/registered?page=2