Clinical trial · Observational
A Study to Evaluate Vaccines Against COVID-19 in the Real World
A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No sponsor
Summary
Brief summary (as posted)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%. Although these randomized clinical trials are considered the "gold standard" for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout. The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Liver Disease | — | UNRESOLVED | — |
| Hepatic Carcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Immunogenicity index-seroconversion rates of neutralizing antibody
- timeFrame
- The 4 weeks after the second dose vaccination
- description
- Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
Secondary outcomes (2)
- measure
- Safety index-incidence of adverse reactions
- timeFrame
- Day 0-28 after each dose vaccination
- description
- Incidence of adverse reactions after each dose vaccination
- measure
- Immunogenicity index-seropositive rates of neutralizing antibody
- timeFrame
- The 4, 12, 24, and 48 weeks after the second dose vaccination
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects received COVID-19 vaccines; * Able to comprehend and provide written informed consent in accordance with institutional guidelines. Exclusion Criteria: * Not received any COVID-19 vaccines; * Not willing to participate and/or give their written informed consent.
References
Publications (0)
Data not yet available