Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey
- Summary
- This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster dose.
- Short title
- Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey
- Official title
- A Phase IIb Randomized Double-Blinded Positive Controlled Trial to Evaluate the Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults Who Have Completed Two Doses of CoronaVac® or the mRNA Vaccine (Comirnaty) in Turkey
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Reason stopped
- The plan has changed
- Completion date
- 2023-01-15
- First posted
- 2021-12-09
- Registry last updated
- 2022-08-11
- Primary completion date
- 2023-01-15
- Start date
- 2022-12-15
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Research and Development Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05150496
- ClinicalTrials.gov ID
- NCT05150496
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Immunogenicity index-GMT of neutralizing antibodies
Timeframe: 14 days (14-28 days) after the booster dose vaccination
GMT of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-Seropositivity rate of neutralizing antibodies
Timeframe: 14 days (14-28 days) after the booster dose vaccination
Seropositivity rate of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-GMI of neutralizing antibodies
Timeframe: 14 days (14-28 days) after the booster dose vaccination
GMI of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-The seropositivity rate of neutralizing antibody
Timeframe: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Seropositivity rate of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibody
Timeframe: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
GMT of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Timeframe: 7 days following the booster dose vaccination
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of unsolicited AEs
Timeframe: 28 days post booster vaccination
Occurrence, intensity, duration, and relationship of unsolicited AEs for 28 days post booster vaccination
Safety index-Occurrence and relationship of SAEs
Timeframe: From the booster dose to 12 months post booster vaccination
Occurrence and relationship of SAEs (from the booster dose to 12 months post booster vaccination)
Safety index-Occurrence and relationship of AESI
Timeframe: From the booster dose to 12 months post booster vaccination
Occurrence and relationship of AESI (from the booster dose to 12 months post booster vaccination)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- Healthy adults aged 18 years and above, who have received 2 prior doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty), with the second dose given 3-8 months (for CoronaVac® recipients) and 6-8 months (for Comirnaty recipients) prior to the day of booster vaccination in the present study;
- Antigen rapid testing negative at the day of enrollment on site or with a PCR negative result within 72 hours before enrollment;
- The participants are able to understand and sign the informed consent voluntarily;
- Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
- The participants are planning to be living in Turkey for the following 1 year after attending this study;
- The participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.
- History of confirmed or currently with the infection of SARS-CoV-2 prior to randomization;
- Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
- Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination in this study;
- Participation in other studies involving study intervention within 30 days prior to vaccination in this study;
- Receipt of attenuated live vaccines in the past 14 days prior to vaccination in this study;
- Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination in this study;
- Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc.);
- Acute febrile illness with axillary temperature >37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to vaccination;
- According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study.
- Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology UnitAnkara, Turkey (Türkiye)
- Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal DiseasesAnkara, Turkey (Türkiye)
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition