Trials / Completed
CompletedNCT02408926
Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Universiteit Antwerpen · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Boostrix | Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation. |
| BIOLOGICAL | 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. |
| BIOLOGICAL | 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. |
| BIOLOGICAL | 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. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2015-04-06
- Last updated
- 2019-10-24
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT02408926. Inclusion in this directory is not an endorsement.