NL-OMON21026
Recruiting
Not Applicable
Preterm infants and second trimester maternal pertussis vaccination
RIVM, UMC0 sites6,750 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- maternal vaccination
- Sponsor
- RIVM, UMC
- Enrollment
- 6750
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older; being pregnant; having an antenatal appointment with a midwife or obstetrician in the 1st trimester of pregnancy; parents who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child.
Exclusion Criteria
- •History of having received a pertussis containing vaccination in the past 2 years; history of having had pertussis disease in the past 5 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 daily corticosteroids within 2 weeks of study entry with exception of corticosteroids to enhance maturation of fetal lungs in case of imminent early delivery; receipt of other immune modulation medication, for instance biologicals; receipt of blood products or immunoglobulins within three months of study entry; 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).
Outcomes
Primary Outcomes
Not specified
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