Pertussis Whooping Cough
Conditions
Interventions
Pregnant woman in group 1 will receives a single dose of Boostrix vaccine
between week 30 and 32 of pregnancy and pregnant woman in group 2 will receive
a single dose of Boostrix vaccine postpartum.
Sponsors
RIVM
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Exclusion criteria for (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 partners or other primary caregivers: - Having experienced a previous severe adverse reaction to any vaccine - History of febrile illness (>38.0*C orally) within the past 72 hours (immunization may be deferred) ;Exclusion criteria for new-borns of participating mothers: - Serious underlying medical condition that can interfere with the results of the study - Premature infants born before 37 weeks gestational age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Serum IgG antibody levels against pertussis vaccine antigen Ptx at 3 months of age, immediately before the start of infant vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| - Serum IgG antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the newborns at birth and at the infants age of 2, 3, 6, 11, 12, 24, 46 and 47 months - Serum IgA antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the new-borns at birth and at infants age of 2, 3, 6, 11, 12, 24, 46 and 47 months - Serum IgG antibody levels against tetanus (T) and diphtheria (D) to assess influence of maternal antibodies on the response to D and T vaccination of the new-borns at birth and at infants age of 2, 3, 6, 11, 12, 24, 46 and 47 months - Serum IgG antibody levels against other concomitantly administered vaccine components Hib, HepB and pneumococcal serotypes (PCV10) of the new-borns at birth and at infants age of 2, 3, 6, 11 and 12 months - Serum IgG antibody levels against pertussis vaccine antigens Ptx, FHA and Prn of the mothers, pre-vaccination, immediately postpartum and at 6, 12, 24 en 47 months after birth - Frequency of local and systemic reactions after Tdap vaccination during pregnancy - Frequency of pertussis specific memory B-cells and plasma cells immediately before and 7-9 days after the booster dose at 11 months - Frequency of pertussis specific memory B-cells and plasma cells immediately before and 28-35 days after the booster dose of around 4 years of age. - Compare infants* pain response and maternal attitude to infant blood collection by heel stick and venipuncture. - Compare IgA levels against pertussis antigens in breast milk of mothers of both groups taken at 7-10 days, 3 months and 6 months after giving birth | — |
Countries
Netherlands
Outcome results
None listed