Vaccination against whooping cough in pregnancy

• Conditions: The number of reported pertussis cases is rising, also in very young infants. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-001936-45-BE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-28
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria
-Women aged 18-35 years
-Willing to be immunized during pregnancy
OR
Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner.
-Age matched controls will be identified in the same time period in the recruiting hospital.
-Intend to be available for follow-up visits and phone call access through 16 months following delivery
-Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination.
-In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician and some of the following criteria:
1.Second trimester ultrasound with no significant abnormalities
2.No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis)
3.Pregnancy estimated to be at low risk (< 1 / 300) for Down's syndrome (trisomy 21), trisomy 13 and trisomy 18 tested at 11-13 weeks of gestation. Appropriate screening test includes any one of the following:
a.second trimester screening based on
i.nuchal translucency measurement,
ii.pregnancy-associated serum protein A (PAPP-A) and free beta- human chorionic gonadotropin (ß-HCG)
taking into account maternal age and pregnancy duration
b.first trimester ultrasound screening and second trimester maternal serum screening test that looks for four specific substances: AFP, total HCG, Estriol (and Inhibin-A), with risk estimated using an integrated, sequential, or contingency approach, and taking into account maternal age
c.second trimester maternal serum screening test that looks for four specific substances: AFP, total hCG, Estriol (and Inhibin-A)

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A. Pregnant women
-Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
-Significant mental illness (e.g. schizophrenia, psychosis, major depression)
-History of a febrile illness (greater than or equal to 38° Celsius) within the past 72 hours before injection
-Previous severe reaction to any vaccine
-Receipt of tetanus-diphtheria toxoid immunization within the past 2 years
-Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years
-Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection
-Receipt of or plans to receive influenza vaccine within the 2 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms).
-Deemed high risk for serious obstetrical complication
-Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk

B.Children with following criteria
-Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
-No signed informed consent by both parents
-Severe reactions to any vaccine
-Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Study & Design

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