Trial · NCT02508194
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. | ||
| SECONDARY | Percentage of Participants Who Had a Post-dose Seroresponse to 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 Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA) | 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 Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA | 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 | Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA | 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 | Number of Participants With Any Solicited Symptoms | Day 1 (post-dose) through Day 7 | ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events | Day 1 (post-dose) through Day 29 | ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs) | Day 1 (post-dose) through end of Season 1 (approximately 1 year) | ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized. | Participants | COUNT_OF_PARTICIPANTS |
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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