Trial · NCT04605159
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (\<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Primary | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Primary | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Secondary | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. |
| Secondary | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Secondary | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Secondary | Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The number of infant participants with all-cause pneumonia is presented in this outcome measure. |
| Secondary | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Secondary | Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery | From study intervention administration (Day 1) to Day 181 post-delivery | RSV-associated MA-RTI is defined as a medically attended visit for RTI symptoms and confirmed RSV infection. |
| Secondary | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | At Day 1 (before study intervention administration), at Day 31 and at delivery | RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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GET https://conductscience.org/api/trials/v1/NCT04605159/registered