Pertussis (Tdap) Vaccination in Pregnancy

Brief Title

Pertussis (Tdap) Vaccination in Pregnancy

Official Title

Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants

Brief Summary

      Despite good vaccination coverage, included in national immunization programs in developed
      countries, the number of reported pertussis cases is rising, also in very young infants.
      Current immunization strategies fail to protect infants too young to be immunized with the
      licensed vaccine. 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. Early humoral immunity will
      be assessed and the influence on vaccine response of the infant measured. The present study
      offers the opportunity to have new insights in neonatal immunological mechanisms against
      pertussis and a better understanding in strategies to protect infants against pertussis.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Does vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), induce sufficiently high maternal antibody concentration in the newborns infants to possibly protect them until their own vaccination starts

Secondary Outcome

 Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time

Condition

Pertussis

Intervention

Pertussis vaccine

Study Arms / Comparison Groups

 control

Description:  50 unvaccinated pregnant women

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

99

Start Date

February 2012

Completion Date

December 2016

Primary Completion Date

December 2015

Eligibility 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.

          -  Availability 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

        Exclusion Criteria:Women:

          -  Serious underlying medical condition

          -  History of a febrile illness (>= 38° Celsius) within the past 72 hours before
             injection

          -  Previous severe reaction to any vaccine

          -  Receipt of tetanus-diphtheria toxoid immunization within the past 1 month

          -  Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
             absorbed (Tdap) immunization in the last 10 years

          -  Receipt of a vaccine, 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 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).

          -  High risk for serious obstetrical complication

          -  Anything in the opinion of the investigator that would put the participant at risk.

        Exclusion criteria for the offspring:

          -  Serious underlying medical condition

          -  No signed informed consent by both parents

          -  Severe reactions to any vaccine

          -  Anything in the opinion of the investigator that would put the participant at risk.
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Elke Leuridan, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT01698346

Organization ID

cev001

Secondary IDs

2011-001936-45

Responsible Party

Principal Investigator

Study Sponsor

Universiteit Antwerpen

Collaborators

 National Institute of Hygiene and Epidemiology, Vietnam

Study Sponsor

Elke Leuridan, MD, PhD, Principal Investigator, Universiteit Antwerpen

Verification Date

October 2019