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

PHASE3CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

August 8, 2022

Primary Completion Date

August 4, 2023

Study Completion Date

August 4, 2023

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 injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine 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 injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine 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 of quadrivalent influenza vaccine 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 of quadrivalent influenza vaccine on day 0, 28.

Trial Locations (4)

222100

Ganyu District Center for Disease Control and Prevention, Lianyungang

222300

Donghai District Center for Disease Prevention and Control, Lianyungang

223300

Huaiyin Center for Diseases Control and Prevention, Huai'an

224500

Binhai District Center for Disease Control and Prevention, Yancheng

All Listed Sponsors
lead

Sinovac Biotech Co., Ltd

INDUSTRY