Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3238 | RSV vaccine formulation 1 Wiki | 1.00 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018357 | Respiratory Syncytial Virus Infections NIH | 0.33 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
The primary objectives of the study are: - To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline neutralizing antibody serostatus. - To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in Respiratory Syncytial Virus (RSV) seronegative participants. The secondary objectives of the study are: - To quantify the amount of vaccine virus shed by each participant by baseline neutralizing antibody serostatus. - To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus after vaccination by baseline neutralizing antibody serostatus. - To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seropositive participants. - To characterize serum RSV-A anti-F immunoglobulin G antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus. - To characterize serum RSV-A antibody responses (neutralizing and anti-F immunoglobulin G) to the study product in each vaccine group after the RSV season by baseline neutralizing antibody serostatus.
Description: Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination.
Measure: Number of participants reporting immediate adverse events Time: Within 30 minutes after vaccinationDescription: Solicited administrative site reaction: rhinorrhea. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Measure: Number of participants reporting solicited reactions Time: Within 28 days after vaccinationDescription: Unsolicited adverse events are spontaneously reported adverse events.
Measure: Number of participants reporting unsolicited adverse events Time: Within 28 days after vaccinationDescription: Adverse events of special interest pre-defined adverse event collected using the same process as for other adverse events.
Measure: Number of participants reporting adverse events of special interest Time: Within 28 days after vaccinationDescription: Medically attended adverse events are adverse events with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department.
Measure: Number of participants reporting medically attended adverse events Time: Within 28 days after vaccinationDescription: Serious adverse events are collected throughout the study, from Day 0 up to 1 month after the end of the RSV season.
Measure: Number of participants reporting serious adverse events Time: Day 0 to maximum Month 12Description: Vaccine induced RSV-A serum neutralizing antibody levels assessed in RSV seronegative participants in Cohorts 1, 2, 3, and 4.
Measure: Vaccine-induced RSV-A serum neutralizing antibody levels after first vaccine administration Time: Day 56Description: Vaccine induced RSV-A serum neutralizing antibody levels are assessed in RSV seronegative participants in Cohorts 2 and 4.
Measure: Vaccine-induced RSV-A serum neutralizing antibody levels after second vaccine administration Time: Day 84Description: Titers are assessed by plaque assay.
Measure: Titer of vaccine virus shedding (plaque assay) Time: 7 and 10 days after vaccinationDescription: Titers are assessed by PCR.
Measure: Titer of vaccine virus shedding (polymerase chain reaction [RT-PCR]) Time: 7 and 10 days after vaccinationDescription: Infection is defined as detection of vaccine in nasal wash by culture or PCR and / or a ≥ 4-fold rise in serum neutralizing antibodies or in serum antibodies to RSV F. Infectivity is assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
Measure: Number of participants infected with the vaccine virus Time: Day 56 and Day 84Description: RSV-A serum neutralizing antibody levels assessed in seropositive participants on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
Measure: Vaccine-induced RSV-A serum neutralizing antibody levels Time: Day 56 and Day 84Description: RSV-A F binding antibody levels assessed on Day 56 for Cohorts 1, 2, 3 and 4, and after vaccination 2 (Day 84) for Cohorts 2 and 4.
Measure: Vaccine-induced RSV-A F binding antibody levels Time: Day 56 and Day 84Description: Serum RSV-A antibody titers (neutralizing and anti-F) are assessed after the end of the RSV season (on average end of March in the Northern Hemisphere and end of September in the Southern Hemisphere).
Measure: RSV-A antibody titers after the RSV surveillance season Time: Within 1 month after the end of the RSV seasonAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports