Trials / Unknown
UnknownNCT05470803
An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine, mRNA Covid-19 Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine as 4th Dose in Individuals Primed/ Boosted With Various Regimens
An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine (AstraZeneca/Fiocruz), mRNA Covid-19 (Comirnaty, Pfizer/Wyeth) Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019-Clover) as 4th Dose in Individuals Primed/ Boosted With Various Regimens
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- D'Or Institute for Research and Education · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is an exploratory phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of various SARS-CoV-2 vaccines. There will be 04 study cohorts, that have previously received 03 doses of the indicated vaccine (s), divided into 10 groups; and each one of the 10 study groups will receive the 4th dose. This exploratory study will enroll up to 360 participants in 4 cohorts and a total of 10 groups: Cohort A (N=90), Cohort B (N= 90), Cohort C (N=150) and Cohort D (N=30). In cohorts A-C participants will be randomized 1:1:1 to three different 4th dose regimens. The number of proposed participants will provide a reasonable accurate descriptive summary of the safety and immunogenicity of the tested vaccination regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AstraZeneca/Fiocruz | 4th dose of SARS-CoV-2 vaccine |
| BIOLOGICAL | Pfizer/Wyeth | 4th dose of SARS-CoV-2 vaccine |
| BIOLOGICAL | Clover SCB-2019 | 4th dose of SARS-CoV-2 vaccine |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2022-12-01
- Completion
- 2023-08-01
- First posted
- 2022-07-22
- Last updated
- 2022-07-22
Locations
3 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05470803. Inclusion in this directory is not an endorsement.