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ID
Source
Brief title
Health condition
maternal vaccination; pertussis; premature; preterm infants
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum IgG antibody levels against vaccine antigen PT in preterm and term infants at 2 months of age, before start of infant vaccination
Secondary outcome
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.
Background summary
Data have shown that 3rd trimester is 91% effective in preventing pertussis in young infants and 95% effective in preventing death due to pertussis. However, data also show that preterm infants profit less form 3rd trimester pertussis vaccination, probably due to insufficient time for antibody transfer. In this prospective cohort study, our primary objective is to evaluate non-inferiority of anti-pertussis toxin IgG in term and preterm infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w gestational age, compared to a historical control group of term and preterm infants born of mothers who were vaccinated between 30-32w gestational age.
Study objective
Non-inferiority of anti-Pertussis Toxin (PT) IgG in term infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w Gestational Age (GA) compared to a reference anti-PT IgG at 2m of age in a historical control group of term infants born of mothers who were vaccinated between 30-32w GA. Likewise, we expect non-inferiotiry of anti-PT IgG in preterm infants at 2m of age born of mothers having received a pertussis vaccine between 20-24w GA compared to the 20 IU/ml anti-PT IgG cut-off used in many immunogenicity studies
Study design
20-24w gestational age, birth, 2 months after delivery
Intervention
maternal pertussis vaccine between 20-24 weeks gestational age
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7403 |
| NTR-old | NTR7619 |
| CCMO | NL66966.000.18 |
| OMON | NL-OMON49737 |