Trials / Unknown
UnknownNCT05886790
A Clinical Trial on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes
A Randomized, Open-Label, Parallel-controlled Clinical Study on Booster Immunization of Two COVID-19 Vaccines Constructed From Different Technical Routes Among People Aged 18 Years and Older
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Zhongnan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, randomized, parallel-controlled clinical trial conducted in people aged 18 years and older to evaluate the immunogenicity and safety of two SARS-CoV-2 bivalent vaccines constructed by adenovirus type 5-based or mRNA-based technics.
Detailed description
The clinical trial plans to recruit 450 subjects aged 18 years and above with an interval of ≥ 3 months between the previous dose of SARS-CoV-2 vaccine immunization and receive one dose of inhaled prototype strain and omicron BA.4/5 bivalent recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-NCO5T-IH), beta strain and omicron BA.4/5 bivalent SARS-CoV-2 mRNA vaccine (mbO5) or inhaled prototype recombinant SARS-CoV-2 vaccine (adenovirus vector type 5) (Ad5-nCoV-IH) for follow-up until 6 months after vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Prototype and Omicron BA.4/5 Bivalent Recombinant COVID-19 Vaccine(Adenovirus Type 5 Vector) For Inhalation | Containing two adenovirus type 5-based vaccines delivering the spike proteins of SARS-CoV-2 wild type and Omicron BA.4/5 mutant, respectively |
| BIOLOGICAL | Bivalent COVID-19 mRNA Vaccine | Containing two mRNA-based vaccines delivering the spike proteins of SARS-CoV-2 Beta and Omicron BA.4/5 mutant, respectively |
| BIOLOGICAL | Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) For Inhalation | Containing adenovirus type 5-based vaccine delivering the spike proteins of SARS-CoV-2 wild type |
Timeline
- Start date
- 2023-05-30
- Primary completion
- 2023-12-31
- Completion
- 2024-05-29
- First posted
- 2023-06-02
- Last updated
- 2023-06-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05886790. Inclusion in this directory is not an endorsement.