Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06208683
Other study ID # PRO-MUM-MA4001-SN
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date November 4, 2023
Est. completion date December 1, 2024

Study information

Verified date November 2023
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date December 1, 2024
Est. primary completion date February 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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; Exclusion Criteria: - 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.; - 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Mumps vaccine, Live (MV)
0.5mL per dose,containing =3.7 lg CCID50 live mumps virus
Influenza Vaccine, inactivated, quadrivlent(QIV)
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.

Locations

Country Name City State
China Qindu Distric Center for Disease Prevention and Control Xianyang Shaanxi
China Xingping Center for Disease Prevention and Control Xianyang Shaanxi
China Yuyang Distict Center for Disease Prevention and Control Yulin Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric mean concentrations (GMCs) of mumps antibody GMC s of mumps antibody 30 days after the vaccination of MV 30 days after the vaccination of MV
Secondary Geometric mean increases (GMIs) of mumps antibody Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV 30 days after the vaccination of MV
Secondary Seroconversion rate of mumps antibody Seroconversion rate of mumps antibody 30 days after the vaccination of MV 30 days after the vaccination of MV
Secondary Seropositivity rate of mumps antibody Seropositivity rate of mumps antibody 30 days after the vaccination of MV 30 days after the vaccination of MV
Secondary Geometric mean titers (GMTs) of influenza antibody Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV 30 days after the vaccination of QIV
Secondary Geometric mean increases (GMIs) of influenza antibody Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV 30 days after the vaccination of QIV
Secondary Seroconversion rate of influenza antibody Seroconversion rate of influenza antibody 30 days after the vaccination of QIV 30 days after the vaccination of QIV
Secondary Seropositivity rate of influenza antibody Seropositivity rate of influenza antibody 30 days after the vaccination of QIV 30 days after the vaccination of QIV
Secondary Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV
Secondary Geometric mean titers (GMTs) of influenza antibody 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
Secondary 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 30 days after the simultaneous vaccination of MV and QIV
Secondary 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 30 days after the simultaneous vaccination of MV and QIV
Secondary 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 30 days after the simultaneous vaccination of MV and QIV
Secondary The incidence of adverse reactions 0-7 days after vaccination The incidence of adverse reactions 0-7 days after vaccination 0-7 days after vaccination
Secondary The incidence of adverse reactions 0-14 days after vaccination The incidence of adverse reactions 0-14 days after vaccination 0-14 days after vaccination
Secondary The incidence of adverse reactions 0-30 days after vaccination The incidence of adverse reactions 0-30 days after vaccination 0-30 days after vaccination
Secondary Geometric mean concentrations (GMCs) of measles antibody before vaccination Geometric mean concentrations (GMCs) of measles antibody before vaccination before vaccination
Secondary Geometric mean concentrations (GMCs) of rubella antibody before vaccination Geometric mean concentrations (GMCs) of rubella antibody before vaccination before vaccination
Secondary Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination before vaccination
Secondary Geometric mean concentrations (GMCs) of mumps antibody before vaccination Geometric mean concentrations (GMCs) of mumps antibody before vaccination before vaccination
Secondary Geometric mean titers (GMTs) of influenza antibody before vaccination Geometric mean titers (GMTs) of influenza antibody before vaccination before vaccination
Secondary Seropositivity rate of measles antibody before vaccination Seropositivity rate of measles antibody before vaccination before vaccination
Secondary Seropositivity rate of rubella antibody before vaccination Seropositivity rate of rubella antibody before vaccination before vaccination
Secondary Seropositivity rate of varicella-zostor antibody before vaccination Seropositivity rate of varicella-zostor antibody before vaccination before vaccination
Secondary Seropositivity rate of mumps antibody before vaccination Seropositivity rate of mumps antibody before vaccination before vaccination
Secondary Seropositivity rate of influenza antibody before vaccination Seropositivity rate of influenza antibody before vaccination before vaccination
Secondary Cross-neutralizing antibody titer of mumps vaccine Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus 30 days after the vaccination of MV alone or simultaneously with QIV
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A