Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorSinovac Biotech Co., Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women aged 18 to 39 years in good health or medically stable.
Gestational age of 20 to 32 weeks, based on last menstrual period, early or late ultrasound dating.
The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according to medical records or rapid tests.
Participants should provide verifiable identification.
Disqualifiers
Receipt of any seasonal influenza vaccine within 6 months prior to enrollment, or plans to receive other influenza vaccines during the study;
Participants with previous or concurrent dangerous pregnancy complications such as gestational diabetes mellitus (GDM), pregnant induced hypertension, preeclampsia and known uterine anomaly;
History of preterm delivery, or spontaneous abortion;
Known fetal congenital anomaly, e.g. genetic abnormality or major congenital malformation based on antenatal ultrasound;
Trial design
Design model
Parallel
Treatments tested in this trial
Participants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
Biological/VaccineParticipants will receive one dose of vaccine (0.5 mL) of Sinovac QIV
Vaxigrip QIV
Biological/VaccineParticipants will receive one dose of vaccine (0.5 mL) of Vaxigrip QIV
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The 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 vaccination2
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 vaccination3
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 vaccination4
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 vaccinationSecondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov