Trial · NCT02508194
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| 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) | Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year. |
| 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) | Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC 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 Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA | Day 29 and End of Season 1 (approximately 1 year) | Palivizumab cELISA 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. |
| 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) | Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a \>= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year. |
| Secondary | Number of Participants With Any Solicited Symptoms | Day 1 (post-dose) through Day 7 | Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever \>= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | Day 1 (post-dose) through Day 29 | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state. |
| 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) | An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year. |
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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