Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
NCT ID: NCT02408926
Last Updated: 2019-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
370 participants
INTERVENTIONAL
2015-04-30
2018-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Women 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).
Boostrix
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Infanrix hexa
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.
Group B
Women 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.
Boostrix
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Quinvaxem
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.
OPV
Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Interventions
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Boostrix
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Infanrix hexa
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.
Quinvaxem
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.
OPV
Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Institut Pasteur de Lille
OTHER
Thrasher Research Fund
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Elke Leuridan, MD, PhD
Prof., MD, PhD
Principal Investigators
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Elke Leuridan, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Chulalongkorn University
Bangkok, , Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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cev002
Identifier Type: -
Identifier Source: org_study_id
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