A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

NCT06049927 | Completed Phase 3

• 1 other identifier: PRO-QINF-3005
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Seasonal Influenza

Outcome Measures

Primary Outcomes (3)

• Seroconversion rates of HI antibody

  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.

  28 days after full schedule immunization

• Geometric Mean Titers (GMTs) of HI antibody

  Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.

  28 days after full schedule immunization

• Number of Participants With Seroprotection to Influenza Vaccine Antigens

  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.

  28 days after full schedule immunization

Secondary Outcomes (5)

• GMIs of HI antibody

  28 days after full schedule immunization

• Incidence of adverse reactions

  0-30 days after each dose

• Incidence of adverse reactions

  0-7 days after each dose

• Incidence of Serious adverse events

  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

Study Arms (4)

Experimental Group of quadrivalent influenza vaccine(0.25ml)

EXPERIMENTAL

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) according to the immunization schedule of day 0,28

Biological: Quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.5ml)

EXPERIMENTAL

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) according to the immunization schedule of day 0,28

Biological: Quadrivalent influenza vaccine(0.5ml)

Control Group of trivalent influenza vaccine(BV)

ACTIVE COMPARATOR

550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) according to the immunization schedule of day 0,28.

Biological: Trivalent influenza vaccine(BV)

Control Group of trivalent influenza vaccine(BY)

ACTIVE COMPARATOR

550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) according to the immunization schedule of day 0,28.

Biological: Trivalent influenza vaccine(BY)

Interventions

Quadrivalent influenza vaccine(0.25ml) BIOLOGICAL

7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses on day 0, 28.

Experimental Group of quadrivalent influenza vaccine(0.25ml)

Quadrivalent influenza vaccine(0.5ml) BIOLOGICAL

15 ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses on day 0, 28.

Experimental Group of quadrivalent influenza vaccine(0.5ml)

Trivalent influenza vaccine(BV) BIOLOGICAL

7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region. And the immunization schedule is two doses on day 0, 28.

Control Group of trivalent influenza vaccine(BV)

Trivalent influenza vaccine(BY) BIOLOGICAL

7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses vaccine on day 0, 28.

Control Group of trivalent influenza vaccine(BY)

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged 6-35 months;
• Proven vaccination certificate and birth certificate;
• The subjects' guardians can understand and voluntarily sign the informed consent form.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (5)

Huoqiu County Center for Disease Control and Prevention

Lu'an, Anhui, 237400, China

Location

Zhushan County Center for Diseases Control and Prevention

Shiyan, Hubei, 442200, China

Location

Nanzhang County Center for Disease Prevention and Control

Xiangyang, Hubei, 441500, China

Location

Laohekou Center for Disease Control and Prevention

Xiangyang, Hubei, 441800, China

Location

Zigui County Center for Disease Control and Prevention

Yichang, Hubei, 443600, China

Location

Related Publications (1)

• Wang L, Li L, Yang W, Pang X, Li D, Zhu T, Wang S, Li T, Tian Y, Jiang Z, Li J, Yang X, Zhao C, Tang J, Tong Y. Immunogenicity and safety of inactivated quadrivalent influenza vaccines in children aged 6-35 months: A multi-center, randomized, double-blind, active-controlled clinical trial. Vaccine. 2026 Jan 25;71:128113. doi: 10.1016/j.vaccine.2025.128113. Epub 2025 Dec 13.

  PMID: 41391373 DERIVED

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Lei Wang

  Hubei Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

• Jihai Tang

  Anhui Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: September 16, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CN (5)