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Pertussis (Tdap) Vaccination in Pregnancy

Primary Purpose

Pertussis, Pregnancy

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pertussis vaccine
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis focused on measuring Pertussis, Infants, Vaccination, Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for the Evaluation of Vaccination
  • National Institute of Hygien and Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control

Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)

Arm Description

50 unvaccinated pregnant women

50 pregnant women vaccinated with pertussis vaccine

Outcomes

Primary Outcome Measures

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
What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN): in women during pregnancy and at delivery after vaccination with TdaP in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16) What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants

Secondary Outcome Measures

Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Infant growth measurement at all time points
Infant growth measurement at all time points
Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy
The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.

Full Information

First Posted
September 21, 2012
Last Updated
October 22, 2019
Sponsor
Universiteit Antwerpen
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT01698346
Brief Title
Pertussis (Tdap) Vaccination in Pregnancy
Official Title
Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Pregnancy
Keywords
Pertussis, Infants, Vaccination, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
50 unvaccinated pregnant women
Arm Title
Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)
Arm Type
Active Comparator
Arm Description
50 pregnant women vaccinated with pertussis vaccine
Intervention Type
Biological
Intervention Name(s)
Pertussis vaccine
Other Intervention Name(s)
Boostrix®, GSK Biologicals, Rixensart
Intervention Description
Vaccination during pregnancy with a pertussis containing vaccine
Primary Outcome Measure Information:
Title
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
Description
What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN): in women during pregnancy and at delivery after vaccination with TdaP in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16) What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Description
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Time Frame
16 months
Title
Infant growth measurement at all time points
Description
Infant growth measurement at all time points
Time Frame
16 months
Title
Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy
Description
The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Leuridan, MD, PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thu Ha Thi Hoang, MD PhD
Organizational Affiliation
National Institute for Hygiene and Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for the Evaluation of Vaccination
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Facility Name
National Institute of Hygien and Epidemiology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
27142328
Citation
Maertens K, Cabore RN, Huygen K, Vermeiren S, Hens N, Van Damme P, Leuridan E. Pertussis vaccination during pregnancy in Belgium: Follow-up of infants until 1 month after the fourth infant pertussis vaccination at 15 months of age. Vaccine. 2016 Jun 30;34(31):3613-9. doi: 10.1016/j.vaccine.2016.04.066. Epub 2016 Apr 30.
Results Reference
derived

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Pertussis (Tdap) Vaccination in Pregnancy

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