Pertussis vaccine Pertussis, maternal immunization, antibody transfer, pertussis vaccine, recombinant pertussistoxin.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant women will be eligible for inclusion if ALL of the following criteria are met at the time of screening: 1. Age of 18 to 40 years at the time of pregnancy 2. Received one dose of Pertagen or Boostagen vaccine or Td vaccine (several brands for Td vaccine) during pregnancy 3. Ultrasound assessment at 18 to 22 weeks of gestation showed no fetal structural abnormality 4. Uncomplicated singleton pregnancy 5. Having completed and relevant medical records available 6. Wiling and able to provide written informed consent for cord blood collection
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria at study entry will not be eligible for participation 1. Any significant congenital abnormality confirmed by ultrasound 2. Fetal abnormality, stillbirth or neonatal death 3. Received pertussis vaccine within 1 year prior to current pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMCs of anti PT-neutralizing, anti-PT and anti-FHA IgG titres in cord sera At delivery time CHO cell assay and ELISA ,Seropositive rates of anti-PT GMCs in infants base on antibody levels in cord sera At delivery time ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of pregnancy and neonatal outcomes at delivery and after delivery At delivery and after delivery Record form ,Seropositive rates of anti-PT GMCs in infants based on antibody levels in cord sera At delivery time ELISA | — |
Countries
Thailand
Contacts
BioNet-Asia Co., Ltd.