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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,300

Participants

Timeline

Start Date

September 16, 2023

Primary Completion Date

May 23, 2024

Study Completion Date

May 23, 2024

Conditions
Seasonal Influenza
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.

Trial Locations (5)

237400

Huoqiu County Center for Disease Control and Prevention, Lu'an

441500

Nanzhang County Center for Disease Prevention and Control, Xiangyang

441800

Laohekou Center for Disease Control and Prevention, Xiangyang

442200

Zhushan County Center for Diseases Control and Prevention, Shiyan

443600

Zigui County Center for Disease Control and Prevention, Yichang

All Listed Sponsors
lead

Sinovac Biotech Co., Ltd

INDUSTRY

NCT06049927 - A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months | Biotech Hunter | Biotech Hunter