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PertussisPhase 4NCT01698346

Pertussis (Tdap) Vaccination in Pregnancy

A Phase 4 study testing Pertussis vaccine in people with Pertussis and Pregnancy, run by Universiteit Antwerpen at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pertussis, Pregnancy
What is being tested?
Pertussis vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
2 sitesin 2 countries
Study dates
Feb 2012to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Centre for the Evaluation of Vaccination

    Antwerp, 2610

Other trials in Belgium

Vietnam1 site

  • National Institute of Hygien and Epidemiology

    Hanoi, 10000

Other trials in Vietnam

About this study

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

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.

Conditions
Pertussis, Pregnancy
Being tested
Pertussis vaccine
Keywords
Pertussis, Infants, Vaccination, Pregnancy
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pertussis vaccineBiological

    Also called Boostrix®, GSK Biologicals, Rixensart

    Vaccination during pregnancy with a pertussis containing vaccine

Study groups in NCT01698346
Study groupRoleWhat they receive
controlNo intervention50 unvaccinated pregnant women
Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)Active comparator50 pregnant women vaccinated with pertussis vaccine
Receives: Biological: Pertussis vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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):
    2. in women during pregnancy and at delivery after vaccination with TdaP
    3. 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)
    4. 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

    Measured: 16 months

Secondary outcomes (3)

  1. 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

    Measured: 16 months

  2. Infant growth measurement at all time points

    Infant growth measurement at all time points

    Measured: 16 months

  3. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01698346
Sponsor's protocol ID
cev001
Other IDs
2011-001936-45
Status last verified
Oct 2019
First submitted
21 Sep 2012
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27142328

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pertussis vaccine in people with Pertussis and Pregnancy, run by Universiteit Antwerpen at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01698346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.

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