Sars-CoV-2 InfectionNCT05362682
Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
An observational study of Sars-CoV-2 Infection, run by International Vaccine Institute at 1 site in Mozambique.
Trial summary
Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Sinopharm Vaccine
- Type of treatment
- Vaccines
- How many people
- 3,000 participants
- Where
- 1 siteMozambique
- Study dates
- 24 Feb 2022to 30 Aug 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in the Dondo District. For surveillance the catchment area will include participants from Dondo Sede and Mafambisse administrative posts. The participant will come for screening in the following health facilities; Dondo, Baptista, Mandruzi, Canhandula, Samora Machel) and in Mafambisse (Mafambisse and Bloco Nove) and at the community level, the study will involve walk-throughs for COVID-19 testing.
Who may be able to join
- They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
- They are at least 18 years of age during first round of mass vaccination.
- Their onset of symptoms was <10 days prior to testing.
- For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.
Who cannot join
- We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
- Any Participant not matching the inclusion criteria mentioned above.
Trial locations and contacts
1 site in 1 country.
Mozambique1 site, 1 recruiting
- Recruiting
Dondo Health Facility
Dondo, 2104
Ilesh Jani, PhD, +258825802221, ilesh.jani@ins.gov.mz
About this study
Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Sinopharm Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinopharm VaccineOther
Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Other: Sinopharm Vaccine | |
| Test Negative Control | Not described Receives: Other: Sinopharm Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease
Protection conferred by two completed doses of Sinopharm vaccine against RT-PCR-confirmed COVID-19 disease measured as the reduction in risk in adults who received two completed doses of the vaccine compared to those who are not vaccinated.
Measured: 2 years
Secondary outcomes (1)
Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection
Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against RT-PCR confirmed severe SARS-CoV-2 infection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start24 Feb 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Coalition for Epidemic Preparedness Innovations (CEPI), Instituto Nacional de Saúde, Mozambique, University of Antananarivo, International Centre for Diarrhoeal Disease Research, Bangladesh, Harvard University, Heidelberg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362682
- Sponsor's protocol ID
- IVI-ECOVA-03
- Status last verified
- Apr 2023
- First submitted
- 2 May 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
- ClinicalTrials.gov ID
- NCT05362682
- Acronym / sponsor ID
- IVI-ECOVA-03
- Conditions
- Sars-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- The Coalition for Epidemic Preparedness Innovations (CEPI), Instituto Nacional de Saúde, Mozambique, University of Antananarivo, International Centre for Diarrhoeal Disease Research, Bangladesh, Harvard University, Heidelberg University
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Sinopharm Vaccine |
| Test Negative Control | – | Other: Sinopharm Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in the Dondo District. For surveillance the catchment area will include participants from Dondo Sede and Mafambisse administrative posts. The participant will come for screening in the following health facilities; Dondo, Baptista, Mandruzi, Canhandula, Samora Machel) and in Mafambisse (Mafambisse and Bloco Nove) and at the community level, the study will involve walk-throughs for COVID-19 testing.
Key inclusion criteria (4 listed)
- They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
- They are at least 18 years of age during first round of mass vaccination.
- Their onset of symptoms was <10 days prior to testing.
- For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.
Key exclusion criteria (2 listed)
- We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
- Any Participant not matching the inclusion criteria mentioned above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinopharm VaccineSinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign | Other | Case, Test Negative Control |
Primary outcome
Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease
Time frame: 2 years
Protection conferred by two completed doses of Sinopharm vaccine against RT-PCR-confirmed COVID-19 disease measured as the reduction in risk in adults who received two completed doses of the vaccine compared to those who are not vaccinated.
1 secondary outcome
Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV-2 Infection, run by International Vaccine Institute at 1 site in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Marks, PhD (+821087033813, fmarks@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.