Maternal Determinants of Infant Immunity to Pertussis

Phase 4

Recruiting

• Conditions: Vaccination; Infection; Maternal-Fetal Relations; Pertussis; Immunoglobulins

• Registration Number: NCT05856396
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br> - For non-pregnant & pregnant women Age between 18 and 45 years Eligible for Tdap<br> vaccination<br><br> - For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent<br> vaccine Age between 2 and 3 months<br><br>Exclusion Criteria:<br><br> - For pregnant and non-pregnant women<br><br> - Inability to understand the nature and extent of the study and the procedures<br> required<br><br> - Grade III/IV anemia,<br><br> - Acute infection at the time of immunization<br><br> - Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or<br> Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis<br><br> - Current or recent use of immunosuppressive drugs<br><br> - Active neoplasia<br><br> - Other vaccine(s) administered at the same time as Tdap vaccination (wash out of<br> 4 weeks after others vaccinations and 28 days after Tdap vaccination )<br><br> - For pregnant women<br><br> - Risk of premature delivery or intrauterine growth retardation<br><br> - Twin or triplet pregnancies<br><br> - For non-pregnant women Last Tdap vaccination < 12 months before<br><br>For infants:<br><br> - Infants born before 35 weeks of gestation<br><br> - Birthweight below 2.5 kg,<br><br> - Severe neonatal distress<br><br> - Serious congenital abnormalities or congenital infection.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA);IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)

Secondary Outcome Measures

Name	Time	Method
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA);CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry