The effects of Pertussis vaccination of pregnant woman on the production of antibody's in the blood of newborns up to 12 months of age

Phase 1

• Conditions: Healthy pregnant woman < 20 months pregnant; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-003090-98-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-09
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

•Pregnant women 18-40 years of age
•Women with a low risk of pregnancy complications as assessed by a midwife/obstetrician/gynaecologist with a normal 20 weeks ultrasound of the fetus
•Women who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child
•Parents have to be willing to have their infant vaccinated with the hexavalent (DaKTP-Hib-Hep) vaccine at 3, 5 and 11 months of age according to the described procedures
•Presence of a signed informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 112
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant Woman:
History of having received a pertussis vaccination in the past 5 years
-History of having received a TD containing vaccine in the past 2 years
-Known or suspected serious underlying condition that can interfere with the results of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness
-Receipt of any high-dose (= 20 mg of prednisone daily or equivalent) daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry
-Receipt of other immune modulating medication, for instance biologicals
-Receipt of blood products or immunoglobulin, within three months of study entry (Rhesus negative women who receive antirhesus (D)- immunoglobuline will not be excluded from the trial)
-Presence of bleeding disorder
-Having experienced a previous severe adverse reaction to any vaccine
-Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza vaccine which may be given concomitantly)
-History of febrile illness (>38.0°C orally) within the past 72 hours (immunization may be deferred)

Exclusion criteria for newborns of participating mothers:
•Serious underlying medical condition that can interfere with the results of the study
•Premature infants born before 37 weeks gestational age

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified