AzTrials
AzTrials

MumpsPhase 4NCT06208683

The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students

A Phase 4 study testing Mumps vaccine, Live (MV) and Influenza Vaccine, inactivated, quadrivlent(QIV) in people with Mumps and Influenza, run by Sinovac Biotech Co., Ltd at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mumps, Influenza
What is being tested?
Mumps vaccine, Live (MV) and Influenza Vaccine, inactivated, quadrivlent(QIV)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
3 sitesChina
Study dates
4 Nov 2023to 1 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Healthy junior high school students;
  • subjects and/or guardians who can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
  • Provision of valid identification.;
  • History of 1 or 2 doses of mumps-containing vaccine;

Who cannot join

  • History of mumps or have completed 3 doses of mumps-containing vaccine;
  • Receipt of the current seasonal influenza vaccine (except subjects in Arm 4)
  • History of asthma or allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
  • Autoimmune disease (such as systemic lupus erythematosus) or a state of immunodeficiency / immunosuppression (such as AIDS, after organ transplantation);
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
Show all 18Show fewer
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, any condition resulting in asplenia or splenectomy;
  • Abnormal coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, topical corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months;
  • Receipt of blood products in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 28 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • Participation in other clinical trials before enrollment and during the follow-up period, or a plan to participate in other clinical trials within 3 months.
  • Any other factors that are unsuitable for participating in this clinical trial according to the investigator's judgment

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Qindu Distric Center for Disease Prevention and Control

    Xianyang, Shaanxi, 712099

  • Xingping Center for Disease Prevention and Control

    Xianyang, Shaanxi, 713199

  • Yuyang Distict Center for Disease Prevention and Control

    Yulin, Shaanxi, 719054

Other trials in China

About this study

Official title: The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With a Quadrivalent Inactivated Influenza Vaccine in Junior High School Students

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

Read the detailed description

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.

Conditions
Mumps, Influenza
Being tested
Mumps vaccine, Live (MV), Influenza Vaccine, inactivated, quadrivlent(QIV)
Medical subject headings
Mumps, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mumps vaccine, Live (MV)Biological

    0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus

  • Influenza Vaccine, inactivated, quadrivlent(QIV)Biological

    0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.

Study groups in NCT06208683
Study groupRoleWhat they receive
1MCV: MVExperimental100 students with a history of 1 dose of MCV will receive 1 dose of MV.
Receives: Biological: Mumps vaccine, Live (MV)
1MCV: QIVExperimental100 students with a history of 1 dose of MCV will receive 1 dose of QIV.
Receives: Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
1MCV: MV +QIVExperimental100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously.
Receives: Biological: Mumps vaccine, Live (MV); Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
2MCV: MVExperimental100 students with a history of 2 dose of MCV will receive 1 dose of MV.
Receives: Biological: Mumps vaccine, Live (MV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric mean concentrations (GMCs) of mumps antibody

    GMC s of mumps antibody 30 days after the vaccination of MV

    Measured: 30 days after the vaccination of MV

Secondary outcomes (26)

  1. Geometric mean increases (GMIs) of mumps antibody

    Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV

    Measured: 30 days after the vaccination of MV

  2. Seroconversion rate of mumps antibody

    Seroconversion rate of mumps antibody 30 days after the vaccination of MV

    Measured: 30 days after the vaccination of MV

  3. Seropositivity rate of mumps antibody

    Seropositivity rate of mumps antibody 30 days after the vaccination of MV

    Measured: 30 days after the vaccination of MV

  4. Geometric mean titers (GMTs) of influenza antibody

    Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV

    Measured: 30 days after the vaccination of QIV

  5. Geometric mean increases (GMIs) of influenza antibody

    Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV

    Measured: 30 days after the vaccination of QIV

  6. Seroconversion rate of influenza antibody

    Seroconversion rate of influenza antibody 30 days after the vaccination of QIV

    Measured: 30 days after the vaccination of QIV

  7. Seropositivity rate of influenza antibody

    Seropositivity rate of influenza antibody 30 days after the vaccination of QIV

    Measured: 30 days after the vaccination of QIV

  8. Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV

    Geometric mean concentrations (GMCs) of mumps antibody

    Measured: 30 days after the simultaneous vaccination of MV and QIV

  9. Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV

    Geometric mean titers (GMTs) of influenza antibody

    Measured: 30 days after the simultaneous vaccination of MV and QIV

  10. 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

    Measured: 30 days after the simultaneous vaccination of MV and QIV

  11. 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

    Measured: 30 days after the simultaneous vaccination of MV and QIV

  12. 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

    Measured: 30 days after the simultaneous vaccination of MV and QIV

  13. The incidence of adverse reactions 0-7 days after vaccination

    The incidence of adverse reactions 0-7 days after vaccination

    Measured: 0-7 days after vaccination

  14. The incidence of adverse reactions 0-14 days after vaccination

    The incidence of adverse reactions 0-14 days after vaccination

    Measured: 0-14 days after vaccination

  15. The incidence of adverse reactions 0-30 days after vaccination

    The incidence of adverse reactions 0-30 days after vaccination

    Measured: 0-30 days after vaccination

  16. Geometric mean concentrations (GMCs) of measles antibody before vaccination

    Geometric mean concentrations (GMCs) of measles antibody before vaccination

    Measured: before vaccination

  17. Geometric mean concentrations (GMCs) of rubella antibody before vaccination

    Geometric mean concentrations (GMCs) of rubella antibody before vaccination

    Measured: before vaccination

  18. Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination

    Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination

    Measured: before vaccination

  19. Geometric mean concentrations (GMCs) of mumps antibody before vaccination

    Geometric mean concentrations (GMCs) of mumps antibody before vaccination

    Measured: before vaccination

  20. Geometric mean titers (GMTs) of influenza antibody before vaccination

    Geometric mean titers (GMTs) of influenza antibody before vaccination

    Measured: before vaccination

  21. Seropositivity rate of measles antibody before vaccination

    Seropositivity rate of measles antibody before vaccination

    Measured: before vaccination

  22. Seropositivity rate of rubella antibody before vaccination

    Seropositivity rate of rubella antibody before vaccination

    Measured: before vaccination

  23. Seropositivity rate of varicella-zostor antibody before vaccination

    Seropositivity rate of varicella-zostor antibody before vaccination

    Measured: before vaccination

  24. Seropositivity rate of mumps antibody before vaccination

    Seropositivity rate of mumps antibody before vaccination

    Measured: before vaccination

  25. Seropositivity rate of influenza antibody before vaccination

    Seropositivity rate of influenza antibody before vaccination

    Measured: before vaccination

  26. Cross-neutralizing antibody titer of mumps vaccine

    Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus

    Measured: 30 days after the vaccination of MV alone or simultaneously with QIV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start4 Nov 2023
  3. Primary completion2 Feb 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208683
Sponsor's protocol ID
PRO-MUM-MA4001-SN
Status last verified
Nov 2023
First submitted
23 Nov 2023
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mumps vaccine, Live (MV) and Influenza Vaccine, inactivated, quadrivlent(QIV) in people with Mumps and Influenza, run by Sinovac Biotech Co., Ltd at 3 sites 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 4 inclusion and 18 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean concentrations (GMCs) of mumps antibody (time frame: 30 days after the vaccination of MV). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06208683.

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 17 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in