This is a randomized, double-blind, positive controlled phase Ⅲ clinical trial to assess the immunogenicity and safety of Sinovac QIV in pregnant women. A total of 150 healthy pregnant women aged 18\~39 years at 20 to 32 weeks of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac QIV or Vaxigrip QIV, respectively. Blood samples will be collected from participants prior to vaccination and 28 days after vaccination. Moreover, to evaluate trans-placental antibodies, blood samples at the end of the gestation period (delivery) and the cord blood sample will be collected, if applicable. For safety assessment, any immediate adverse events within 30 minutes, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected within 8 weeks after delivery. Pregnancy and birth outcomes will be collected as well.
This is a randomized, double-blind, positive controlled phase Ⅲ clinical trial to assess the immunogenicity and safety of Sinovac QIV in pregnant women. A total of 150 healthy pregnant women aged 18\~39 years at 20 to 32 weeks of pregnancy will be enrolled. Written informed consent form (ICF) will be obtained from participants before enrollment. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac QIV or Vaxigrip QIV, respectively. For immunogenicity assessment, blood samples will be collected from participants prior to vaccination and 28 days after vaccination. Moreover, to evaluate trans-placental antibodies, blood samples at the end of the gestation period (delivery) and the cord blood sample will be collected, if applicable. For safety assessment, any immediate adverse events within 30 minutes after vaccine administration, solicited local and systemic adverse events within 7 days and unsolicited adverse events within 28 days will be collected. Serious adverse events will be collected within 8 weeks after delivery. Pregnancy and birth outcomes will be collected by medical record review from enrollment through hospital discharge following delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
Participants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV
Health Cube Medical Clinics
Mandaluyong, National Capital Region, Philippines
RECRUITINGUniversity of the Philippines - Philippine General Hospital (UP-PGH)
Manila, National Capital Region, Philippines
RECRUITINGThe seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
SCR 28 days after vaccination.
Time frame: 28 days after vaccination
The seroprotection rates (SPRs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
SPR 28 days after vaccination.
Time frame: 28 days after vaccination
The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
GMT 28 days after vaccination.
Time frame: 28 days after vaccination
The geometric mean increase (GMI) of hemagglutination inhibition (HI) antibodies against each antigen 28 days after vaccination.
GMI 28 days after vaccination.
Time frame: 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination
Incidence of adverse reactions within 28 days after vaccination
Time frame: 28 days after vaccination
The maternal seroconversion rates (SCRs) of HI antibodies against each antigen at the end of gestation period
SCRs at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The maternal seroprotection rates (SPRs) of HI antibodies against each antigen at the end of gestation period
SPRs at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The maternal geometric mean titers (GMTs) of HI antibodies against each antigen at the end of gestation period
GMTs at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The maternal geometric mean increase (GMI) of HI antibodies against each antigen at the end of gestation period
GMI at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The SPR of HI antibodies against each antigen in the umbilical cord blood at the end of gestation period
SPR in the umbilical cord blood at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
The GMT of HI antibodies against each antigen in the umbilical cord blood at the end of gestation period
GMT in the umbilical cord blood at the end of gestation period
Time frame: at the end of gestation period (date of delivery, estimated to be 4-17 weeks after randomization)
Incidence of adverse reactions within 7 days after vaccination.
Adverse reactions within 7 days after vaccination.
Time frame: 7 days after vaccination
Incidence of serious adverse events within 8 weeks after delivery.
serious adverse events within 8 weeks after delivery.
Time frame: 8 weeks after delivery
Incidence of pregnancy and birth outcomes
pregnancy and birth outcomes
Time frame: 8 weeks after delivery
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