‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?

Phase 1

• Conditions: women in their first trimester of pregnancy; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-002976-41-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1.18 years or older
2.Being pregnant
3.Having an antenatal appointment with a midwife or obstetrician in the 1st trimester of pregnancy
4.Signed informed consent
5.Parents who are willing to adhere to the protocol and perform all planned visits and
sample collections for themselves and their newborn child (only relevant for the immunogenicity part

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.All women with one or more missing inclusion criteria
2.History of having received a pertussis containing vaccination in the past 2 years.
3.History of having had pertussis disease in the past 5 years.
4.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.
5.Receipt of any high-dose (=20 mg of prednisone daily or equivalent) daily corticosteroids within 2 weeks of study entry (inhaled or other local steroids are acceptable) with exception of corticosteroids to enhance maturation of fetal lungs in case of imminent early delivery.
6.Receipt of other immune modulating medication, for instance biologicals.
7.Receipt of blood products or immunoglobulins, within three months of study entry
(Rhesus negative women who receive anti-rhesus (D)- immunoglobulin will not be
excluded from the study).
8.Presence of bleeding disorder.
9.Having experienced a previous severe adverse reaction to any vaccine.
10.Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza
vaccine which may be given concomitantly).

Study & Design

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