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Antibody level in cord sera following immunization with recombinant acellular pertussis vaccines during pregnancy: a prospective, observational study

Antibody level in cord sera following immunization with recombinant acellular pertussis vaccines during pregnancy: a prospective, observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20200528006
Enrollment
600
Registered
2020-05-28
Start date
2019-01-21
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis vaccine Pertussis, maternal immunization, antibody transfer, pertussis vaccine, recombinant pertussistoxin.

Interventions

Pregnant women who previously received one dose of Pertagen vaccine during pregnancy and obtain antenatal care and deliver at King Chulalongkorn Memorial Hospital. ,Pregnant women who previously rec
Pertagen vaccine,Boostagen vaccine,Td vaccine (several brands for Td vaccine)

Sponsors

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

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

MeasureTime 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

MeasureTime 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

Public ContactSouad Mansouri

BioNet-Asia Co., Ltd.

souad.m@bionet-asia.com023618110

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026