Stay updated on ABNCoV2 Vaccine in Previous SARS-CoV-2 Vaccinated Adults Clinical Trial

Sign up to get notified when there's something new on the ABNCoV2 Vaccine in Previous SARS-CoV-2 Vaccinated Adults Clinical Trial page.
Latest website image capture
Clouds background image

Latest updates to the ABNCoV2 Vaccine in Previous SARS-CoV-2 Vaccinated Adults Clinical Trial page

  1. Check
    today
    No Change Detected
  2. Check
    yesterday
    No Change Detected
  3. Check
    3 days ago
    No Change Detected
  4. Check
    4 days ago
    Change Detected
    Summary
    The study has expanded to include 57 locations, and the revision has been updated from v2.9.7 to v2.10.0.
    Difference
    0.3%
    Check dated 2024-07-23T14:55:08.000Z thumbnail image
  5. Check
    5 days ago
    No Change Detected
  6. Check
    11 days ago
    Change Detected
    Summary
    The website has been updated to Revision v2.9.7 from v2.9.6.
    Difference
    0.1%
    Check dated 2024-07-16T08:23:04.000Z thumbnail image
  7. Check
    25 days ago
    Change Detected
    Summary
    The value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent change in the webpage content.
    Difference
    0.1%
    Check dated 2024-07-02T13:58:23.000Z thumbnail image
  8. Check
    30 days ago
    Change Detected
    Summary
    The value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent change in the webpage content.
    Difference
    0.1%
    Check dated 2024-06-27T10:00:00.000Z thumbnail image
  9. Check
    31 days ago
    Change Detected
    Summary
    The value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.
    Difference
    0.1%
    Check dated 2024-06-26T08:47:14.000Z thumbnail image
  10. Check
    32 days ago
    Change Detected
    Summary
    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus related topics: Vaccines FDA Drug and Device Resources Show less Design Details Primary Purpose : Prevention Allocation : Randomized Interventional Model : Parallel Assignment Masking : Double ( Participant Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : ABNCoV2 100μg single dose ABNCoV2 100μg single dose Biological : ABNCoV2 ABNCoV2 100μg single dose Active Comparator : Comirnaty Comirnaty Biological : Comirnaty Comirnaty Primary Outcome Measures Outcome Measure Measure Description Time Frame Non-inferiority, or superiority in terms of neutralizing antibodies against the SARS-CoV-2 index virus (Wuhan wild type isolate), in Part A Cohort 1 and 2 To assess non-inferiority, or superiority, of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against the SARS-CoV-2 index virus (Wuhan wild type isolate), in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination). - Geometric mean titer (GMT) of neutralizing antibodies against the SARS-CoV-2 index virus at 2 weeks after trial vaccination, in each Part A cohort 2 weeks after vaccination Secondary Outcome Measures Outcome Measure Measure Description Time Frame Non-inferiority, or superiority, in terms of neutralizing antibodies against SARS-CoV-2 variants of concern (VOCs). To assess in Part A cohorts the non-inferiority, or superiority, of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against SARS-CoV-2 variants of concern (VOCs) circulating at time of the trial. - GMT of neutralizing antibodies against the SARS-CoV-2 VOCs circulating at time of the trial, at 2 weeks after trial vaccination, in the Part A cohort(s) in which the primary endpoint success criterion is met 2 weeks after vaccination Neutralizing antibody titers against the SARS-CoV-2 index virus after vaccination with ABNCoV2 To assess neutralizing antibody titers against the SARS-CoV-2 index virus after vaccination with ABNCoV2 in the immunogenicity subsets of Part B Cohort 1 and Cohort 2. - GMTs of neutralizing antibodies against the SARS-CoV-2 index virus at 2 weeks after trial vaccination in subjects receiving ABNCoV2 in the immunogenicity subsets of Part B Cohort 1 and Cohort 2. 2 weeks after vaccination Safety and tolerability of the ABNCoV2 vaccine as measured by the incidence of solicited and unsolicited adverse events occurring during or after the trial vaccination. Part A: For all subjects receiving ABNCoV2 compared to those receiving Comirnaty, the percent who report the below: Parts A and B: For all subjects receiving ABNCoV2, the percent who report the below: Serious adverse events (SAEs) or adverse events of special interest (AESIs) assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up. Grade 3 or higher adverse events (AEs) assessed as related to trial vaccine in the 8 day period starting with the day of vaccination. SAEs, AESIs or medically attended AEs (MAAEs), regardless of relationship, during the active trial phase. SAE, AESI or MAAEs, regardless of relationship, during the entire trial period. Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase. Solicited local AEs in the 8 day period starting with the day of vaccination. Solicited general AEs in the 8 day period starting with the day of vaccination. During active trial phase (defined as the period from the trial vaccination up to and including the end of active trial phase (EAP) visit at 28 to 35 days after trial vaccination) or during entire trial period for SAE/AESI Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. No Revision: v2.9.1.'
    Difference
    25%
    Check dated 2024-06-25T08:24:36.000Z thumbnail image

Stay in the know with updates to ABNCoV2 Vaccine in Previous SARS-CoV-2 Vaccinated Adults Clinical Trial

Enter your email address, and we'll notify you when there's something new on the ABNCoV2 Vaccine in Previous SARS-CoV-2 Vaccinated Adults Clinical Trial page.