Skip to main content

Table 2 Trial schedule

From: Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC]

  1. 1Screening visit may be performed on the same day as visit 1
  2. 2Informed consent must be signed prior to initiating any study procedures;
  3. 3Randomization is subjected to vaccine availability;
  4. 4Visit 1: third vaccine shot for participant (only one vaccine booster dose will be administered for the study);
  5. 5Physical examination will be done by a qualified study team member or a treating licensed healthcare provider. The physical examination on visit 1 will be conducted during screening prior to vaccination;
  6. 6Vital signs include pulse, systolic and diastolic blood pressure, respiratory rate, and body temperature prior to vaccination and blood collection;
  7. 7For women of child bearing potential, a urine pregnancy test will be conducted;
  8. 8At each study visit, a review for PCR-confirmed COVID-19 infection will be conducted. In most cases, such information will be available in the participant’s HealthHub mobile app;
  9. 9All AEs including a list of solicited and other events will be recorded for 7 days after vaccination. Unsolicited AEs will be recorded up to day 28 after vaccination. SAE will be recorded from study’s vaccination until the end of study period at 12 months. They will be assessed via the listed study procedures, safety laboratory tests, and participant self-recorded diary;
  10. 10Hematology tests include full blood count with differential and platelet counts;
  11. 11Liver panel includes albumin, total bilirubin, alkaline phosphatase (ALP), and alanine transaminase (ALT); Renal panel includes sodium, potassium, and creatinine;
  12. 12Cardiology panel includes creatine kinase and troponin;
  13. 13Blood samples will be collected at NCID research clinic, de-identified/coded before dispatch to research laboratories such as A*STAR Singapore Immunology Network, Duke-NUS and NCID’s National Public Health Laboratory. The study team based at NCID research clinic will maintain the codes linking the blood samples to its donor. Subjected to participant consent, any de-identified leftover blood samples may also be analyzed for exploratory research to find new scientific information about coronaviruses and related diseases, which may occur locally or overseas;
  14. 14Blood sample for immunogenic studies may be taken at Visit 1 instead of screening visit if blood draw at screening is not possible. The study team will make every effort to complete all blood-taking in one seating to minimize the number of needle pricks.
Back to article page

Trials

ISSN: 1745-6215