A Phase 4 interventional study of Mumps vaccine, Live (MV) and Influenza Vaccine, inactivated, quadrivlent(QIV) in Mumps and Influenza, sponsored by Sinovac Biotech Co., Ltd. Active, not recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains
This study is an open-lable, randomised, controlled phase Ⅳ clinical trial in healthy junior high school students to the immunogenicity and safety of the booster doses of a mumps vaccine (MV) administrated alone and concomitantly with a quadrivalent influenza vaccine (QIV) in healthy junior high school students. The experimental vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. A total of 400 healthy students will be enrolled, including 300 students who have received one dose of mumps-containing vaccine (MCV) before vaccination, and 100 students who have received two doses of mumps-containing vaccine before vaccination. 300 students with a history of 1 dose of MCV will be randomly divided into 3 groups in a ratio of 1:1:1, and will receive 1 dose of MV alone, 1 dose of QIV alone, or 1 dose of MV and 1 dose of QIV simultaneously. Students with a history of 2 doses of MCV received 1 dose of MV alone. Blood samples were collected before and 30 days after vaccination. Pre-vaccination blood samples were used to detect antibody levels of measles, mumps, influenza and varicella, and post-vaccination blood samples were used to detect mumps antibodies and/or influenza antibodies corresponding to the vaccination.
83 studies on the registry are indexed under Mumps; 8 are open to participants now.
This study's enrollment of 400 is below the median of 897 across 70 interventional studies indexed under Mumps.
Browse Mumps studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are 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:
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 students with a history of 1 dose of MCV will receive 1 dose of MV.
Biological: Mumps vaccine, Live (MV)
100 students with a history of 1 dose of MCV will receive 1 dose of QIV.
Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously.
Biological: Mumps vaccine, Live (MV) · Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
100 students with a history of 2 dose of MCV will receive 1 dose of MV.
Biological: Mumps vaccine, Live (MV)
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.
Geometric mean concentrations (GMCs) of mumps antibody
GMC s of mumps antibody 30 days after the vaccination of MV
Time frame: 30 days after the vaccination of MV
Geometric mean increases (GMIs) of mumps antibody
Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV
Time frame: 30 days after the vaccination of MV
Seroconversion rate of mumps antibody
Seroconversion rate of mumps antibody 30 days after the vaccination of MV
Time frame: 30 days after the vaccination of MV
Seropositivity rate of mumps antibody
Seropositivity rate of mumps antibody 30 days after the vaccination of MV
Time frame: 30 days after the vaccination of MV
Geometric mean titers (GMTs) of influenza antibody
Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV
Time frame: 30 days after the vaccination of QIV
Geometric mean increases (GMIs) of influenza antibody
Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV
Time frame: 30 days after the vaccination of QIV
Seroconversion rate of influenza antibody
Seroconversion rate of influenza antibody 30 days after the vaccination of QIV
Time frame: 30 days after the vaccination of QIV
Seropositivity rate of influenza antibody
Seropositivity rate of influenza antibody 30 days after the vaccination of QIV
Time frame: 30 days after the vaccination of QIV
Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV
Geometric mean concentrations (GMCs) of mumps antibody
Time frame: 30 days after the simultaneous vaccination of MV and QIV
Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV
Geometric mean titers (GMTs) of influenza antibody
Time frame: 30 days after the simultaneous vaccination of MV and QIV
Geometric mean increases (GMIs) of mumps antibody and influenza antibody
Geometric mean increases (GMIs) of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
Time frame: 30 days after the simultaneous vaccination of MV and QIV
Seroconversion rate of mumps antibody and influenza antibody
Seroconversion rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
Time frame: 30 days after the simultaneous vaccination of MV and QIV
Seropositivity rate of mumps antibody and influenza antibody
Seropositivity rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
Time frame: 30 days after the simultaneous vaccination of MV and QIV
The incidence of adverse reactions 0-7 days after vaccination
The incidence of adverse reactions 0-7 days after vaccination
Time frame: 0-7 days after vaccination
The incidence of adverse reactions 0-14 days after vaccination
The incidence of adverse reactions 0-14 days after vaccination
Time frame: 0-14 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination
Time frame: 0-30 days after vaccination
Geometric mean concentrations (GMCs) of measles antibody before vaccination
Geometric mean concentrations (GMCs) of measles antibody before vaccination
Time frame: before vaccination
Geometric mean concentrations (GMCs) of rubella antibody before vaccination
Geometric mean concentrations (GMCs) of rubella antibody before vaccination
Time frame: before vaccination
Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
Time frame: before vaccination
Geometric mean concentrations (GMCs) of mumps antibody before vaccination
Geometric mean concentrations (GMCs) of mumps antibody before vaccination
Time frame: before vaccination
Geometric mean titers (GMTs) of influenza antibody before vaccination
Geometric mean titers (GMTs) of influenza antibody before vaccination
Time frame: before vaccination
Seropositivity rate of measles antibody before vaccination
Seropositivity rate of measles antibody before vaccination
Time frame: before vaccination
Seropositivity rate of rubella antibody before vaccination
Seropositivity rate of rubella antibody before vaccination
Time frame: before vaccination
Seropositivity rate of varicella-zostor antibody before vaccination
Seropositivity rate of varicella-zostor antibody before vaccination
Time frame: before vaccination
Seropositivity rate of mumps antibody before vaccination
Seropositivity rate of mumps antibody before vaccination
Time frame: before vaccination
Seropositivity rate of influenza antibody before vaccination
Seropositivity rate of influenza antibody before vaccination
Time frame: before vaccination
Cross-neutralizing antibody titer of mumps vaccine
Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus
Time frame: 30 days after the vaccination of MV alone or simultaneously with QIV
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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