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PertussisPhase 4NCT02408926

Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand

A Phase 4 study testing Boostrix, Infanrix hexa and Quinvaxem in people with Pertussis, run by Universiteit Antwerpen at 1 site in Thailand.

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

Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. 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
What is being tested?
Boostrix, Infanrix hexa and Quinvaxem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteThailand
Study dates
Apr 2015to Aug 2018
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

  • Willing to be immunized with a pertussis containing vaccine during pregnancy
  • Intend to be available for follow-up visits and phone call through 19 months postpartum
  • Willing to have infant immunized with a pertussis containing vaccine at 2, 4, 6 months and 18 months of age according to EPI (Expanded Programme of Immunization) and receiving (randomized) either acellular pertussis (aP) (study vaccine) or a whole cell pertussis (wP) vaccine. Consent for participation of the child is needed by both married parents or by a single unmarried other.
  • At low risk for pregnancy related complications as determined by the investigator and a second trimester ultrasound with no significant abnormalities.

Who cannot join

  • Pregnant subjects
  • Multiple pregnancies
  • Serious obstetrical risk
  • Serious underlying medical condition
  • Significant mental illness
  • History of febrile illness (greater than or equal to 38°C) within the past 72 hours before injection
Show all 18Show fewer
  • Previous severe reaction to any vaccine
  • Receipt of tetanus-diphtheria toxoid immunization within the past 1 month Receipt of an pertussis containing vaccine (Tdap) in the last 5 years
  • Receipt of a vaccine, blood product (excluding Rhogam) within the 4 weeks prior to injection through 4 weeks following injection and IVIG (Intravenous Immunoglobulins) within 12 weeks period. One month interval should be respected with another vaccine (except influenza) in orde to evaluate Adverse events following one or both vaccines (fever, local symptoms)
  • Receipt of an experimental drug during pregnancy
  • Anything in the opinion of the investigator that would prevent women from completing the study or put the woman at risk
  • Infants
  • Preterm delivery before 37 weeks of gestation
  • Serious underlying medical condition
  • Children suffering from primary humoral immune disorders; suffering from primary cellular immune deficiencies and disorders from the complete cascade
  • No informed consent from one or both married parents
  • Severe reactions to any vaccine
  • Anything in the opinion of the investigator that would prevent children from completing the study or put the child at risk

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies.

However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.

Conditions
Pertussis
Being tested
Boostrix, Infanrix hexa, Quinvaxem, OPV
Keywords
Pertussis, Pregnancy, Humoral immune response, Functionality, Vaccination
Medical subject headings
Whooping Cough

What participants receive

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

  • BoostrixBiological

    Also called Acellular pertussis containing vaccine

    Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.

  • Infanrix hexaBiological

    Also called Acellular pertussis containing vaccine

    Children from group A will be vaccinated with an acellular pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

  • QuinvaxemBiological

    Also called Whole cell pertussis containing vaccine

    Children from group B will be vaccinated with a whole cell pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

  • OPVBiological

    Also called Oral Polio Vaccine

    Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.

Study groups in NCT02408926
Study groupRoleWhat they receive
Group AExperimentalWomen will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a hexavalent acellular pertussis containing vaccine (Infanrix hexa).
Receives: Biological: Boostrix; Biological: Infanrix hexa
Group BActive comparatorWomen will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a pentavalent whole cell pertussis containing vaccine (Quinvaxem). OPV (oral poliovirus vaccine) will also be administered at 2, 4, 6 and 18 months.
Receives: Biological: Boostrix; Biological: Quinvaxem; Biological: OPV

What is being measured

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

  1. kinetics of Pertussis toxin (PT) IgG titers in infants

    Measurement of anti- Pertussis Toxin (PT) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine

    Measured: from birth until 19 months of age

  2. kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants

    Measurement of anti- Filamentous Haemmaglutinin (FHA) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine

    Measured: from birth until 19 months of age

  3. kinetics of Pertactin (Prn) IgG titers in infants

    Measurement of anti- Pertactin (Prn) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine

    Measured: from birth until 19 months of age

Secondary outcomes (3)

  1. Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay

    functionality of the passively acquired anti-PT antibodies in infants following maternal vaccination during pregnancy with an acellular pertussis containing vaccine (Boostrix), as assessed with a newly validated luminescence based assay

    Measured: At birth

  2. Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay

    To measure the functionality of the anti-PT antibodies in infants vaccinated with either an acellular pertussis containing vaccine (Infanrix hexa) or a whole cell pertussis vaccine (Quinvaxem), after maternal vacicnation during pregnancy, assessed with a newly validated luminescence based assay

    Measured: At month 7 and month 19

  3. Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies

    Efficacy as assessed by the ratio of cord and maternal titers of IgG antibodies

    Measured: Birth

Timeline

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

  1. First posted6 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02408926
Sponsor's protocol ID
cev002
Status last verified
Oct 2019
First submitted
23 Mar 2015
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Sereeyothin C, Kerr SJ, Poovorawan Y, Maertens K, Wanlapakorn N. The effect of preexisting antibodies from Tdap vaccination during pregnancy on infant antibody responses to the pertussis-containing vaccines. Hum Vaccin Immunother. 2025 Dec;21(1):2575638. doi: 10.1080/21645515.2025.2575638. Epub 2025 Oct 22.

    PubMed 41122946

  • Wanlapakorn N, Sarawanangkoor N, Srimuan D, Thatsanathorn T, Klinfueng S, Poovorawan Y. Persistence of hepatitis B surface antibody until 7 years of age following administration of hexavalent and pentavalent vaccines in children at 2, 4, 6, and 18 months. Vaccine X. 2024 Sep 20;20:100561. doi: 10.1016/j.jvacx.2024.100561. eCollection 2024 Oct.

    PubMed 39385752

  • Sarawanangkoor N, Wanlapakorn N, Srimuan D, Thatsanathorn T, Thongmee T, Poovorawan Y. Persistence of Antibodies against Measles, Mumps, and Rubella after the Two-Dose MMR Vaccination: A 7-Year Follow-Up Study. Vaccines (Basel). 2024 Jul 5;12(7):744. doi: 10.3390/vaccines12070744.

    PubMed 39066382

  • Wanlapakorn N, Sarawanangkoor N, Srimuan D, Thatsanathorn T, Thongmee T, Poovorawan Y. Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines. Hum Vaccin Immunother. 2024 Dec 31;20(1):2352909. doi: 10.1080/21645515.2024.2352909. Epub 2024 May 16.

    PubMed 38752802

  • Embacher S, Maertens K, Herzog SA. Half-life Estimation of Pertussis-Specific Maternal Antibodies in (Pre)Term Infants After In-Pregnancy Tetanus, Diphtheria, Acellular Pertussis Vaccination. J Infect Dis. 2023 Nov 28;228(11):1640-1648. doi: 10.1093/infdis/jiad212.

    PubMed 37285482

  • Hu S, Logan N, Puenpa J, Wanlapakorn N, Vongpunsawad S, Poovorawan Y, Willett BJ, Hosie MJ. Evaluation of the effect of maternally derived antibody on response to MMR vaccine in Thai infants. Vaccine. 2022 Mar 1;40(10):1439-1447. doi: 10.1016/j.vaccine.2022.01.049. Epub 2022 Feb 5.

    PubMed 35135700

  • Wanlapakorn N, Puenpa J, Thongmee T, Srimuan D, Thatsanathorn T, Vongpunsawad S, Poovorawan Y. Antibodies to measles, mumps, and rubella virus in Thai children after two-dose vaccination at 9 months and 2.5 years: A longitudinal study. Vaccine. 2020 May 19;38(24):4016-4023. doi: 10.1016/j.vaccine.2020.04.013. Epub 2020 Apr 21.

    PubMed 32331806

  • Wanlapakorn N, Maertens K, Vongpunsawad S, Puenpa J, Tran TMP, Hens N, Van Damme P, Thiriard A, Raze D, Locht C, Poovorawan Y, Leuridan E. Quantity and Quality of Antibodies After Acellular Versus Whole-cell Pertussis Vaccines in Infants Born to Mothers Who Received Tetanus, Diphtheria, and Acellular Pertussis Vaccine During Pregnancy: A Randomized Trial. Clin Infect Dis. 2020 Jun 24;71(1):72-80. doi: 10.1093/cid/ciz778.

    PubMed 31418814

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Boostrix, Infanrix hexa and Quinvaxem in people with Pertussis, run by Universiteit Antwerpen at 1 site in Thailand.

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 4 inclusion and 18 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 1 site in Thailand. 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?

kinetics of Pertussis toxin (PT) IgG titers in infants (time frame: from birth until 19 months of age). The study lists 3 primary outcomes in all. 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 NCT02408926, which also lists 8 linked publications.

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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