Trials / Unknown
UnknownNCT05480436
Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population
Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: a Multicentre, Randomised, Controlled, Phase 4 Trial
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- China National Biotec Group Company Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
Detailed description
Participants aged ≥18 undergoing hemodialysis were recruited and randomly assigned to one of three study groups. Experimental Group : The participants received the first dose of BBIBP-Corv and IIV4 simultaneously on Day 0, and received the second dose of BBIBP-Corv and PPV23 simultaneously on Day 28. Control Group 1: The participants received two doses of BBIBP-Corv on Day 0 and Day 28, respectively. Control Group 2 : The participants received one doses of IIV4 on Day 0 and received one doses of PPV23 on Day 28. Three blood samples were collected on days 0, 28 and 56 to test humoral immunity, and three blood samples were collected on days 0, 42 and 56 to test cellular immunity to SARS-CoV-2. Any local or systemic adverse events after vaccination will be recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | coadministration | the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and IIV4 on Day 0, and the coadministration of BBIBP-CorV and PPV23 on Day 28 |
| BIOLOGICAL | COVID-19 vaccine | received two doses of inactivated COVID-19 vaccine (BBIBP-CorV) |
| BIOLOGICAL | IIV4+PPV23 | received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28 |
Timeline
- Start date
- 2022-08-05
- Primary completion
- 2023-01-30
- Completion
- 2023-07-30
- First posted
- 2022-07-29
- Last updated
- 2022-08-30
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05480436. Inclusion in this directory is not an endorsement.