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

NCT06049927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2025-08-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

Quadrivalent influenza vaccine(0.25ml)

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.

BIOLOGICAL

Quadrivalent influenza vaccine(0.5ml)

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.

BIOLOGICAL

Trivalent influenza vaccine(BV)

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.

BIOLOGICAL

Trivalent influenza vaccine(BY)

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.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lei Wang · Hubei Provincial Center for Disease Prevention and Control

  • Jihai Tang · Anhui Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-16
Primary Completion
2024-05-23
Completion
2024-05-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049927 on ClinicalTrials.gov