Comparative Evaluation of Covid-19 Vaccines Response
1 other identifier
observational
1,500
1 country
4
Brief Summary
Study Population Population with vaccinated with three different Covid Vaccines (Inactive Vaccine (Sinovac Life Sciences, Beijing, China), recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V), mRNA Vaccine (Pfizer/BionTEC). This is multi center study, 5 centers will be joined to study from different part of the country. Approximately 1500 people will be enrolled to study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJuly 15, 2021
July 1, 2021
1 year
May 14, 2021
July 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody at 12 months
* Baseline Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 14th day after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 3 Months after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 6 Months after second dose * Change of Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody levels at 12 Months after second dose
12 Months
Study Arms (3)
Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China).
\- Any person, male or female, over 18 years of age, were vaccinated with Inactive Vaccine.
Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V).
\- Any person, male or female, over 18 years of age, were vaccinated with recombinant human adenovirus serotype number 26.
Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).
\- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine.
Interventions
Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.
Eligibility Criteria
\- Any person, male or female, over 18 years of age.
You may qualify if:
- \- Any person, male or female, over 18 years of age.
- The patient has signed an informed consent form.
- The patient was vaccinated with SARS-CoV-2 vaccine.
You may not qualify if:
- Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- Person under safeguard of justice
- Person under guardianship or curator ship.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Karamanoglu Mehmetbey University
Karaman, 70200, Turkey (Türkiye)
Selcuk University
Konya, 42250, Turkey (Türkiye)
Tekirdag Namık Kemal University, Faculty of Medicine
Tekirdağ, Turkey (Türkiye)
Karadeniz Technic University, Faculty of Medicine
Trabzon, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pulmonary Medicine
Study Record Dates
First Submitted
May 14, 2021
First Posted
May 20, 2021
Study Start
June 1, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
July 15, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share