A Phase IV Clinical Trial of Influenza Vaccine (Split Virion), Inactivatedin (Anflu®) Pregnant Women (AnFLU-PREG)
A Phase IV, Randomized, Double-blind, Positive-controlled , Multicenter Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion) , Inactivated (Anflu®) in Pregnant Women
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) 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 Influenza Vaccine (Split Virion) , Inactivated (Anflu®) or Sanofi VAXIGRIP®, respectively.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A phase IV clinical trial of Influenza Vaccine (Split Virion), Inactivated (Anflu®) developed by Sinovac Biotech Co., Ltd will be conducted in Chinese pregnant women.
A total of 150 healthy pregnant women aged 18~45 years at 22 to 34 weeks (+6 days) of pregnancy will be enrolled.The trial is a randomized, double-blind, positive controlled study to evaluate the immunogenicity and safety of Influenza Vaccine (Split Virion) ,Inactivated (Anflu®) manufactured by Sinovac. The active control vaccine is VAXIGRIP® manufactured by Sanofi.
For immunogenicity assessment, blood samples will be collected from participants prior to vaccination, 28 days post-vaccination, and at the end of pregnancy (at delivery) to evaluate antibody levels in pregnant women following influenza vaccination. Additionally, the cord blood samples will be collected at delivery to assess transplacental antibody transfer to the fetus. Antibodies will be tested using the hemagglutination-inhibition (HI) assay.
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 from the time of informed consent signature until 3 months after delivery (or until 3 months after the event if pregnancy termination occurs). Pregnancy and neonatal outcomes will be collected by medical record review .
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qi Hongbo
- Número de teléfono: 13808376116
- Correo electrónico: qihongbo@cqmu.edu.cn
Ubicaciones de estudio
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Changsha, Porcelana
- Hunan Provincial Maternal and Child Health Care Hospital
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Contacto:
- Tang Yabing
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Chengdu, Porcelana
- Chengdu Women's and Children's Central Hospital
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Contacto:
- Lai Fan
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Chongqing, Porcelana
- The First Affiliated Hospital of Chongqing Medical University
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Contacto:
- Qi Hongbo
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Guangzhou, Porcelana
- Nanfang Hospital, Southern Medical University
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Contacto:
- Huang Liping
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Nanjing, Porcelana
- Nanjing Drum Tower Hospita
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Contacto:
- Li Jie
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Wuhan, Porcelana
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contacto:
- Feng Ling
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy pregnant women aged 18 to 45 years (inclusive) with stable health status, at 22 to 34 weeks (+6 days) of gestation. Gestational age is determined based on early ultrasound examination, or based on the last menstrual period if early ultrasound is unavailable.
- Participants are able to understand and sign the informed consent form voluntarily;
- Participants are willing and able to adhere to visit schedules and maintain accessible contact throughout the study period;
- Participants should provide verifiable identification;
- Have a singleton pregnancy;
- Have normal non-invasive prenatal DNA test and systematic ultrasound results during the current pregnancy; normal amniocentesis results are required if the test has been performed.
Exclusion Criteria:
- Have a history of two or more preterm deliveries (delivery before 37 weeks of gestation), previous infants with low birth weight (birth weight <2500 g), or a history of neonatal asphyxia or neonatal neurological damage;
- Have a history of multiple unexplained spontaneous abortions;
- Have received any influenza vaccine or the influenza vaccine for the current influenza season within 6 months prior to enrollment, or plan to receive influenza vaccination during the study period.
- Have suffered from seasonal influenza within 6 months prior to enrollment.
- Have a history of Guillain-Barré syndrome within 6 weeks after previous influenza vaccination.
- Have allergic reactions or other severe adverse reactions to any influenza vaccine or its components.
- Have severe autoimmune diseases or immunodeficiency diseases (including but not limited to active systemic lupus erythematosus, rheumatoid arthritis, asplenia, functional asplenia, and HIV infection) and are judged unsuitable for vaccination by the investigator.
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders or platelet abnormalities).
- Have severe chronic diseases (including but not limited to cardiovascular diseases, partial liver diseases, renal diseases or malignant tumors) that may interfere with the study as judged by the investigator.
- Have a current or previous history of severe neurological diseases (epilepsy, convulsions) or psychiatric disorders, or have a family history of psychiatric disorders.
- Received corticosteroids (adult prednisone ≥20 mg/day or equivalent) or other immunosuppressants for ≥14 days, or cytotoxic therapy within 6 months prior to vaccination, or plan to receive such therapy during the study period.
- Received immunoglobulins or other blood products within 3 months prior to vaccination, or plan to receive such products during the study period.
- Received any vaccine within 28 days prior to study vaccination, or plan to receive any vaccine within 28 days after study vaccination.
- Have enrolled in other clinical trials of investigational drugs or vaccines during the follow-up period, or plan to receive investigational drugs or vaccines during the study period.
- Have acute diseases or acute exacerbation of chronic diseases within 7 days before vaccination.
- Have fever on the scheduled vaccination day with an axillary temperature ≥37.3 °C before vaccination.
- Have clinically significant abnormal laboratory findings as judged by the investigator, or meet any of the following laboratory criteria: a) White blood cell count >15.0×10^9/L; b) Neutrophil percentage >85%; c) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (2×ULN); d) Total bilirubin >2 times the upper limit of normal (2×ULN).
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Test Group
100 participants will receive one dose of vaccine (0.5 mL) of Sinovac Influenza Vaccine (Split Virion) Inactivated (Anflu®) . Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
Participants will receive one dose of Sinovac Anflu® . |
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Comparador activo: Control Group
50 participants will receive one dose of vaccine (0.5 mL) of VAXIGRIP® manufactured by Sanofi. Route of administration is intramuscular injection at deltoid muscle of upper arm.Immunization schedule is 1 dose |
Participants will receive one dose of Sanofi Vaxigrip®. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The seroconversion rates (SCRs) of hemagglutination inhibition (HI) antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: 28 days after vaccination
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer <1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer. |
28 days after vaccination
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Incidence of adverse reactions within 28 days after vaccination
Periodo de tiempo: 28 days after vaccination
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Incidence of adverse reactions within 28 days after vaccination. Adverse reactions include solicited and unsolicited adverse reactions. Solicited local (injection site) symptoms: pain, swelling, erythema, induration, pruritus; Solicited systemic (non-injection site) symptoms: fever (axillary temperature), fatigue, myalgia, headache, hypersensitivity reaction. |
28 days after vaccination
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The seroprotection rates (SPRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: 28 days after vaccination
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40. |
28 days after vaccination
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The geometric mean titers (GMTs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: 28 days after vaccination
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs. |
28 days after vaccination
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The geometric mean fold rises (GMFRs) of HI antibodies at day 28 ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: 28 days after vaccination
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Geometric mean of antibody fold-rise with two-sided 95% CI will be calculated , along with the geometric mean ratio and its corresponding two-sided 95% CI. |
28 days after vaccination
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The SCRs of HI antibodies at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery , estimated to be 6-18 weeks after randomization.
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroconversion is defined as either a baseline HI titer <1:10 and a post-vaccination titer ≥1:40 or a baseline HI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HI antibody titer. |
At the date of delivery , estimated to be 6-18 weeks after randomization.
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The SPRs of HI antibodies at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery , estimated to be 6-18 weeks after randomization.
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40. |
At the date of delivery , estimated to be 6-18 weeks after randomization.
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The GMTs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery , estimated to be 6-18 weeks after randomization.
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs. |
At the date of delivery , estimated to be 6-18 weeks after randomization.
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The GMFRs of HI antibodies at delivery,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery , estimated to be 6-18 weeks after randomization.
|
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Geometric mean of antibody fold-rise with two-sided 95% CI will be calculated , along with the geometric mean ratio and its corresponding two-sided 95% CI. |
At the date of delivery , estimated to be 6-18 weeks after randomization.
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The SPRs of HI antibodies in cord blood at delivery ,as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery, estimated to be 6-18 weeks after randomization
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Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Seroprotection is defined as an HI titer ≥1: 40. |
At the date of delivery, estimated to be 6-18 weeks after randomization
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The GMTs of HI antibodies in cord blood at delivery, as measured by HAI assay for vaccine-matched influenza A and B
Periodo de tiempo: At the date of delivery, estimated to be 6-18 weeks after randomization
|
Influenza A included H1N1 and H3N2 and influenza B strains included Victoria-lineage. Log-transformed post-vaccination HI antibody titer will be the dependent variable, with treatment group as fixed effect and log-transformed pre-vaccination HI antibody titer as covariate. Least-squares mean differences with two-sided 95% CIs will be estimated and back-transformed via exponentiation to derive adjusted GMT ratios (experimental vs control) and corresponding two-sided 95% CIs. |
At the date of delivery, estimated to be 6-18 weeks after randomization
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Incidence of serious adverse events from vaccination through 3 months after delivery.
Periodo de tiempo: From vaccination to 3 months after delivery.
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Serious adverse events within 3 months after delivery. |
From vaccination to 3 months after delivery.
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Pregnancy outcomes
Periodo de tiempo: At the date of delivery, estimated to be 6-18 weeks after randomization
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Pregnancy outcomes: term birth, preterm birth, elective termination of pregnancy, fetal death, and gestational complications, etc. |
At the date of delivery, estimated to be 6-18 weeks after randomization
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Neonatal birth outcomes
Periodo de tiempo: 3 months after delivery
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Birth outcomes: normal status, low birth weight, congenital malformations, neonatal NICU admission, and neonatal death, etc. |
3 months after delivery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Qi Hongbo, First Affiliated Hospital of Chongqing Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO-INF-4015
Información sobre medicamentos y dispositivos, documentos del estudio
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