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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001936-45 | EudraCT Number |
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| Name | Class |
|---|---|
| National Institute of Hygiene and Epidemiology, Vietnam | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | 50 unvaccinated pregnant women | |
| Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart) | Active Comparator | 50 pregnant women vaccinated with pertussis vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertussis vaccine | Biological | Vaccination during pregnancy with a pertussis containing vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 months |
| Infant growth measurement at all time points |
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Inclusion Criteria:
Exclusion Criteria:Women:
Exclusion criteria for the offspring:
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| Name | Affiliation | Role |
|---|---|---|
| Elke Leuridan, MD, PhD | Universiteit Antwerpen | Principal Investigator |
| Thu Ha Thi Hoang, MD PhD | National Institute for Hygiene and Epidemiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for the Evaluation of Vaccination | Antwerp | 2610 | Belgium | |||
| National Institute of Hygien and Epidemiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27142328 | Derived | 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. |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Infant growth measurement at all time points |
| 16 months |
| 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. | 12 months |
| Hanoi |
| 10000 |
| Vietnam |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |