maternal vaccination
Conditions
Interventions
maternal pertussis vaccine between 20-24 weeks gestational age
Sponsors
RIVM, UMCU
Eligibility
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IgG antibody levels against vaccine antigen PT in preterm and term infants at 2 months of age, before start of infant vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-Pertissis toxin (PT), pertacin (Prn), filamentous hemagglutinin (FHA) concentrations, tetanus or diphteria in the mother at delivery, in the infant at birth (cord blood) or at 2m of age. Decay in anti-PT, Prn, FHA, tetanus and diphteria in infants from birth at 2m of months of age. Ratio between GMCs and GMCs at birth. Frequency in systemic (adverse) events occuring within 7 days before or 7 days after vaccination vaccination. Frequency of determinants of acceptance of 2nd trimester pertussis vaccination. Determinants of women's attitude towards maternal pertussis vaccination between 20-24w GA. | — |
Contacts
Public ContactMaarten Immink
RIVM - UMCU
Outcome results
None listed