A Phase 4 interventional study of Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine and Inactivated SARS-CoV-2 vaccine coadministered with MMR in SARS-CoV-2 Infection, Varicella and Measles, sponsored by Shanghai Municipal Center for Disease Control and Prevention. Not yet recruiting at 1 site in China. Open to participants aged 4 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Shanghai Municipal Center for Disease Control and Prevention · Phase 4, Interventional, and Prevention
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 540 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Municipal Center for Disease Control and Prevention is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
First dose exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Biological: Inactivated SARS-CoV-2 vaccine administered alone
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Drug page: Inactivated SARS-CoV-2 Vaccine
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
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
Time frame: 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
Time frame: 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
Time frame: on day 28 after vaccination
incidence of reported vaccine-related adverse events within 28 days of each immunization.
adverse events including local and systemic symptoms followng immunization
Time frame: from 0 to 28 days after vaccination
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inactivated SARS-CoV-2 Vaccine
Shanghai Municipal Center for Disease Control and Prevention