A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
- Summary
- A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.
- Short title
- A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
- Official title
- An Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-05-23
- First posted
- 2023-09-22
- Registry last updated
- 2025-08-14
- Primary completion date
- 2024-05-23
- Start date
- 2023-09-16
- Actual participants
- 3,300
- Participants
- 3,300
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 2:2:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06049927
- ClinicalTrials.gov ID
- NCT06049927
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Seroconversion rates of HI antibody
Timeframe: 28 days after full schedule immunization
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<1：10 and post-vaccination titer ≥1:40, and Significant increase was defined as pre-vaccination titer≥1:40 and ≥ 4-fold increase of post-vaccination titer.
Geometric Mean Titers (GMTs) of HI antibody
Timeframe: 28 days after full schedule immunization
Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Timeframe: 28 days after full schedule immunization
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer ≥1:40 at pre-vaccination and at post-final vaccination.
GMIs of HI antibody
Timeframe: 28 days after full schedule immunization
Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination
Incidence of adverse reactions
Timeframe: 0-30 days after each dose
Incidence of adverse reaction 0-30 days after each dose
Incidence of adverse reactions
Timeframe: 0-7 days after each dose
Incidence of adverse reaction 0-7 days after each dose
Incidence of Serious adverse events
Timeframe: Since the beginning of vaccination until 6 months after the last dose
Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose
Incidence of AESI
Timeframe: since the beginning of vaccination until 6 months after the last dose
Incidence of AESI since the beginning of vaccination until 6 months after the last dose
- Sex
- All
- Age groups
- Children
- Minimum age
- 6 Months
- Maximum age
- 35 Months
- Healthy volunteers
- Yes
- Healthy infants aged 6-35 months;
- Proven vaccination certificate and birth certificate;
- The subjects' guardians can understand and voluntarily sign the informed consent form.
- Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
- Suffering from seasonal influenza in the past 6 moths;
- Axillary temperature >37.0°C;
- History of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders);
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation)
- Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxic therapy in the past 6 months;
- Acute diseases or acute exacerbation of chronic diseases in the past 3 days;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
- Huoqiu County Center for Disease Control and PreventionLu'an, China
- Zhushan County Center for Diseases Control and PreventionShiyan, China
- Nanzhang County Center for Disease Prevention and ControlXiangyang, China
- Laohekou Center for Disease Control and PreventionXiangyang, China
- Zigui County Center for Disease Control and PreventionYichang, China
- PubMed 41391373Related publication