NCT01698346

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

September 21, 2012

Last Update Submit

October 22, 2019

Conditions

PertussisPregnancy

Keywords

PertussisInfantsVaccinationPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

    1. What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN): 1. in women during pregnancy and at delivery after vaccination with TdaP 2. 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) 2. 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

    16 months

Secondary Outcomes (3)

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

    16 months

  • Infant growth measurement at all time points

    16 months

  • Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy

    12 months

Study Arms (2)

control

NO INTERVENTION

50 unvaccinated pregnant women

Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)

ACTIVE COMPARATOR

50 pregnant women vaccinated with pertussis vaccine

Biological: Pertussis vaccine

Interventions

Pertussis vaccineBIOLOGICAL

Vaccination during pregnancy with a pertussis containing vaccine

Also known as: Boostrix®, GSK Biologicals, Rixensart
Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for the Evaluation of Vaccination

Antwerp, 2610, Belgium

Location

National Institute of Hygien and Epidemiology

Hanoi, 10000, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 27142328DERIVED

MeSH Terms

Conditions

Whooping Cough

Interventions

Pertussis VaccineBoostrix

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Elke Leuridan, MD, PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Thu Ha Thi Hoang, MD PhD

    National Institute for Hygiene and Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 3, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

BE(1)VN(1)