SARS-CoV-2 InfectionPhase 4NCT05952505
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
A Phase 4 study testing Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine, Inactivated SARS-CoV-2 vaccine coadministered with MMR and Inactivated SARS-CoV-2 vaccine administered alone in people with SARS-CoV-2 Infection and Varicella, run by Shanghai Municipal Center for Disease Control and Prevention at 1 site in China.
Trial summary
Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. Read more about this study
- Who is it for?
- Ages 4 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Varicella, Measles
- What is being tested?
- Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine, Inactivated SARS-CoV-2 vaccine coadministered with MMR and Inactivated SARS-CoV-2 vaccine administered alone
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Dec 2024
- Phase
- Phase 4
- 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 4 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 4 years old
- With legal guardian signing the informed consent
- Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
- With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
- the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
- With an axillary temperature ≤37.5℃ at the time of vaccination
Who cannot join
- First dose exclusion criteria:
- With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
- allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
- Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
- With acute illness, severe or acute attack of chronic illness or fever
- With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
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- Received non specific immunoglobulin within 3 months
- Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：
- Occurrence of any serious adverse event that may be related to the previous dose of study vaccine
- Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination
- Any new situations that fit the first dose exclusion criteria
- Any situation that researchers thought that might influence the consequence of the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai Municipality, 021
Zhuoying Huang, 86-21-62758710, huangzhuoying@scdc.sh.cn
About this study
Official title: Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Varicella Vaccine and Measles, Mumps and Rubella Combined Vaccine in Shanghai, China: A Non-inferiority, Open-label, Randomised, Controlled, Phase 4 Trial
Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
- Conditions
- SARS-CoV-2 Infection, Varicella, Measles, Mumps, Rubella
- Being tested
- Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine, Inactivated SARS-CoV-2 vaccine coadministered with MMR, Inactivated SARS-CoV-2 vaccine administered alone
- Keywords
- Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine
- Medical subject headings
- COVID-19, Chickenpox, Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccineBiological
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Inactivated SARS-CoV-2 vaccine coadministered with MMRBiological
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Inactivated SARS-CoV-2 vaccine administered aloneBiological
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. Receives: Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine |
| Group 2 | Experimental | immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28. Receives: Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR |
| Group 3 | Active comparator | immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. Receives: Biological: Inactivated SARS-CoV-2 vaccine administered alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
Measured: on day 28 after vaccination
non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
Measured: on day 28 after vaccination
non-inferiority of the seroconversion rate and IgG antibody level against varicella
IgG antibodies of varicella is an index of immunogenicity
Measured: on day 28 after vaccination
Secondary outcomes (1)
incidence of reported vaccine-related adverse events within 28 days of each immunization.
adverse events including local and systemic symptoms followng immunization
Measured: from 0 to 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Center for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Principal investigator, HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention
- Investigators
- Zhuoying Huang, Study director, Shanghai Municipal Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952505
- Sponsor's protocol ID
- SH2023-9
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Varicella Vaccine and Measles, Mumps and Rubella Combined Vaccine in Shanghai, China: A Non-inferiority, Open-label, Randomised, Controlled, Phase 4 Trial
- ClinicalTrials.gov ID
- NCT05952505
- Acronym / sponsor ID
- SH2023-9
- Conditions
- SARS-CoV-2 Infection, Varicella, Measles, Mumps, Rubella
- Keywords
- Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Shanghai Municipal Center for Disease Control and PreventionUniversity, hospital or other
- Collaborators
- China National Biotec Group Company Limited
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jul 2023 (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.
Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccineimmunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. |
| Group 2 | Experimental | Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMRimmunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28. |
| Group 3 | Active comparator | Biological: Inactivated SARS-CoV-2 vaccine administered aloneimmunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 4 years old
- With legal guardian signing the informed consent
- Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
- With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
- the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
Key exclusion criteria (12 listed)
- With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
- allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
- Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
- With acute illness, severe or acute attack of chronic illness or fever
- With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
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 |
|---|---|---|
| Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccineSubjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine. | Biological | Group 1 |
| Inactivated SARS-CoV-2 vaccine coadministered with MMRSubjects will be coadministered with SARS-CoV-2 vaccine and MMR. | Biological | Group 2 |
| Inactivated SARS-CoV-2 vaccine administered aloneSubjects will be immunized with inactivated SARS-CoV-2 vaccine alone | Biological | Group 3 |
Primary outcome
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
Time frame: on day 28 after vaccination
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
Time frame: on day 28 after vaccination
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
non-inferiority of the seroconversion rate and IgG antibody level against varicella
Time frame: on day 28 after vaccination
IgG antibodies of varicella is an index of immunogenicity
1 secondary outcome
incidence of reported vaccine-related adverse events within 28 days of each immunization.
Time frame: from 0 to 28 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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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.
Zhuoying Huang study director
Shanghai Municipal Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine, Inactivated SARS-CoV-2 vaccine coadministered with MMR and Inactivated SARS-CoV-2 vaccine administered alone in people with SARS-CoV-2 Infection and Varicella, run by Shanghai Municipal Center for Disease Control and Prevention at 1 site in China.
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 6 inclusion and 12 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 Jul 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhuoying Huang (86-21-62758710, huangzhuoying@scdc.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2 (time frame: on day 28 after vaccination). The study lists 3 primary outcomes in all. 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 Jul 2023.