Trial · NCT02508194
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
NCT02508194, Phase 2, Terminated, MedImmune LLC; results first posted 2017-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy of MEDI7510 in Older Adults. Trials, record NCT02508194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02508194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
- NCT number
- NCT02508194
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1,900 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Respiratory Syncytial Virus
- Interventions
- MEDI7510, IIV, Placebo
- First posted
- 2015-07-24
- Last updated
- 2017-12-26
- Results first posted
- 2017-12-20
- Limitations and caveats
- The study was terminated due to failure to meet the primary efficacy endpoint.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 | Day 14 after dosing through end of surveillance period (approximately 7 months) | ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year. |
| Secondary | Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 | Day 14 after dosing through end of surveillance period (approximately 7 months) | Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year. |
| Secondary | Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Day 1, Day 29, and End of Season 1 (approximately 1 year) | Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year. |
| Secondary | Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay | Day 29 and End of Season 1 (approximately 1 year) | Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year. |
| Secondary | Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay | Day 29 and End of Season 1 (approximately 1 year) | Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (\>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year. |
| Secondary | Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine | Day 1 (post-dose) and Day 29 of Season 1 | GMT was calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year. |
| Secondary | Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine | Day 29 of Season 1 | Geometric mean fold change was calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year. |
| Secondary | Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody | Day 29 of Season 1 | Seroresponse was defined as a \>= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year. |
| Secondary | Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay | Day 29 and End of Season 1 (approximately 1 year) | Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 \[mean (log2 xi)\], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year. |
| Secondary | Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay | Day 29 and End of Season 1 (approximately 1 year) | Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 \[mean (log2 yi)\], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 | Day 14 after dosing through end of surveillance period (approximately 7 months) | Per-protocol population: All participants in the as-treated population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 | Day 14 after dosing through end of surveillance period (approximately 7 months) | Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population. | Percentage of Participants | NUMBER |
| SECONDARY | Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Day 1, Day 29, and End of Season 1 (approximately 1 year) | Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. | Fragment antigen-binding (F AB) unit/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay | Day 29 and End of Season 1 (approximately 1 year) | Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. | Fold Change | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay | Day 29 and End of Season 1 (approximately 1 year) | Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510. | Percentage of Participants | NUMBER |
| SECONDARY | Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine | Day 1 (post-dose) and Day 29 of Season 1 | Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine | Day 29 of Season 1 | Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. | Fold Change | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody | Day 29 of Season 1 | Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine. | Percentage of Participants | NUMBER |
| SECONDARY | Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay | Day 29 and End of Season 1 (approximately 1 year) | Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure. | ||
| SECONDARY | Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay | Day 29 and End of Season 1 (approximately 1 year) | Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 | Placebo + IIV | 1.6 | Percentage of Participants | ||
| Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 | MEDI7510 + IIV | 1.7 | Percentage of Participants | ||
| Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 | Placebo + IIV | 1.6 | Percentage of Participants | ||
| Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 | MEDI7510 + IIV | 1.7 | Percentage of Participants | ||
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Placebo + IIV | Day 1 | 83.39 | 95% Confidence Interval 78.91 to 88.12 | Fragment antigen-binding (F AB) unit/mL |
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | MEDI7510 + IIV | Day 1 | 77.96 | 95% Confidence Interval 73.66 to 82.50 | Fragment antigen-binding (F AB) unit/mL |
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Placebo + IIV | Day 29 | 80.05 | 95% Confidence Interval 75.68 to 84.68 | Fragment antigen-binding (F AB) unit/mL |
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | MEDI7510 + IIV | Day 29 | 999.03 | 95% Confidence Interval 944.40 to 1056.81 | Fragment antigen-binding (F AB) unit/mL |
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | Placebo + IIV | End of Season 1 | 79.95 | 95% Confidence Interval 75.27 to 84.93 | Fragment antigen-binding (F AB) unit/mL |
| Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay | MEDI7510 + IIV | End of Season 1 | 370.88 | 95% Confidence Interval 350.90 to 391.99 | Fragment antigen-binding (F AB) unit/mL |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Inactivated Influenza Vaccine (IIV) | 949 | |
| Overall Study | STARTED | MEDI7510 + IIV | 951 | |
| Overall Study | COMPLETED | Placebo + Inactivated Influenza Vaccine (IIV) | 897 | |
| Overall Study | COMPLETED | MEDI7510 + IIV | 907 | |
| Overall Study | NOT COMPLETED | Placebo + Inactivated Influenza Vaccine (IIV) | 52 | |
| Overall Study | NOT COMPLETED | MEDI7510 + IIV | 44 |
Source ClinicalTrials.gov
Adverse events226
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 | Fatigue | General disorders | Placebo + IIV | 11 | 948 | 13 |
| other | Fatigue | General disorders | MEDI7510+IIV | 16 | 946 | 19 |
| other | Injection site pain | General disorders | Placebo + IIV | 18 | 948 | 35 |
| other | Injection site pain | General disorders | MEDI7510+IIV | 10 | 946 | 28 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo + IIV | 10 | 948 | 10 |
| other | Upper respiratory tract infection | Infections and infestations | MEDI7510+IIV | 16 | 946 | 16 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo + IIV | 10 | 948 | 10 |
| other | Viral upper respiratory tract infection | Infections and infestations | MEDI7510+IIV | 13 | 946 | 13 |
| other | Headache | Nervous system disorders | Placebo + IIV | 13 | 948 | 15 |
| other | Headache | Nervous system disorders | MEDI7510+IIV | 10 | 946 | 11 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + IIV | 5 | 948 |
| Total, all-cause mortality | MEDI7510+IIV | 3 | 946 |
| Total, other adverse events | Placebo + IIV | 52 | 948 |
| Total, other adverse events | MEDI7510+IIV | 48 | 946 |
| Total, serious adverse events | Placebo + IIV | 57 | 948 |
| Total, serious adverse events | MEDI7510+IIV | 64 | 946 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo + IIV vs MEDI7510 + IIV: Number of Participants With Any Solicited Symptoms | Trial comparisons |
| Placebo + IIV vs MEDI7510 + IIV: Number of Participants With Treatment-Emergent Adverse Events | Trial comparisons |
| Placebo + IIV vs MEDI7510+IIV: deaths from any cause | Trial comparisons |
| Placebo + IIV vs MEDI7510+IIV: serious adverse events | 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/NCT02508194
GET https://conductscience.org/api/trials/v1/NCT02508194/results?page=2