---
title: Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)
nct_id: NCT05216484
overall_status: UNKNOWN
phase: PHASE3
sponsor: Chinese Academy of Medical Sciences
study_type: INTERVENTIONAL
primary_condition: SARS-CoV-2 Infection
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05216484.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05216484"
ct_last_update_post_date: 2022-05-23
last_seen_at: "2026-05-12T07:29:07.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)

**NCT ID:** [NCT05216484](https://clinicaltrials.gov/study/NCT05216484)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 480
- **Lead Sponsor:** Chinese Academy of Medical Sciences
- **Collaborators:** Hubei Provincial Center for Disease Control and Prevention
- **Conditions:** SARS-CoV-2 Infection
- **Start Date:** 2022-02-18
- **Completion Date:** 2022-12-30
- **CT.gov Last Update:** 2022-05-23

## Brief Summary

To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Axillary temperature ≤37.0 ℃.
2. aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion Criteria:

1. Persons with a clear history of SARS-CoV-2 infection.
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.
```

## Arms

- **two doses CoronaVac group** (EXPERIMENTAL) — the third does was given 6 months after two doses CoronaVac group
- **two doses BBIBP-CorV** (EXPERIMENTAL) — the third does was given 6 months after two doses BBIBP-CorV
- **first does CoronaVac and second does BBIBP-CorV** (EXPERIMENTAL) — the third does was given 6 months after first does CoronaVac and second does BBIBP-CorV
- **first does BBIBP-CorV and second does CoronaVac** (EXPERIMENTAL) — the third does was given 6 months after first does BBIBP-CorV and second does CoronaVac

## Interventions

- **SARS-CoV-2 Vaccine, Inactivated (Vero Cell)** (BIOLOGICAL) — the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

## Primary Outcomes

- **Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2** _(time frame: From 0 days to 6 month after the third dose)_ — Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
- **SARS-CoV-2 specific memory B and T cell response** _(time frame: From 0 days to 6 month after the third dose)_ — SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
- **Adverse reactions/events rate** _(time frame: 7 days after vaccination)_ — Occurence of adverse reactions/events after vaccination
- **Adverse reactions/events rate** _(time frame: 28 days after vaccination)_ — Occurence of adverse reactions/events after vaccination

## Locations (1)

- Xiangyang City Centers for Disease Control and Prevention, Xiangyang, Hubei, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xiangyang city centers for disease control and prevention|xiangyang|hubei|china` — added _(2026-05-12)_

---

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