NCT04895007

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

May 14, 2021

Last Update Submit

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.

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA 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.

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).

\- Any person, male or female, over 18 years of age, were vaccinated with mRNA Vaccine.

Biological: Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine

Interventions

Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.

Group, vaccinated with Inactive Vaccine (Sinovac Life Sciences, Beijing, China).Group, vaccinated with mRNA Vaccine (Pfizer/BionTEC).Group, vaccinated with recombinant human adenovirus serotype number 26 (rAd26 of Sputnik V).

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- 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)

RECRUITING

Selcuk University

Konya, 42250, Turkey (Türkiye)

RECRUITING

Tekirdag Namık Kemal University, Faculty of Medicine

Tekirdağ, Turkey (Türkiye)

NOT YET RECRUITING

Karadeniz Technic University, Faculty of Medicine

Trabzon, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Interventions

mRNA Vaccines

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex MixturesAntigensBiological Factors

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

Locations