Last updated: 02/06/2019 08:10:18
Immunogenicity of a single dose of GSK Biologicals’ Boostrix™ in infants prior to primary pertussis vaccination, when administered to pregnant women as per routine practice in Bogota, Colombia
GSK study ID
201522
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Immunogenicity of a single dose of GSK Biologicals’ diphtheria, tetanus and acellular pertussis (dTpa) booster vaccine (Boostrix™ [263855]) in infants prior to primary pertussis vaccination, when administered to pregnant women as per routine practice in Bogota, Colombia
Trial description: The purpose of the study is to support the recommendation of vaccination of all pregnant women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of pertussis specific IgG antibodies from mother to the child.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
Timeframe: For cord blood sample - Visit 1 (Day 0). For blood samples collected from infants prior to their first routine primary pertussis vaccination – Visit 2 (at approximately 4-8 weeks of age of subjects).
Secondary outcomes:
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
Timeframe: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Timeframe: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
Interventions:
Enrollment:
18
Primary completion date:
2018-22-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria-Tetanus-Acellular Pertussis
Product
GSK2105254A, GSK2647153A
Collaborators
Not applicable
Study date(s)
May 2018 to October 2018
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 8 weeks
Accepts healthy volunteers
Yes
- Criteria applicable at screening (before the birth of the infant):
- Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
- Criteria applicable at screening (before the birth of the infant):
- Infants whose parents are below the legal consenting age of the country.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
- Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from both parents of the infant. Criteria applicable at enrolment (after the birth of the infant):
- Confirmation of written informed consent obtained from both parents of the infant at the time of screening.
- Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Criteria applicable at screening (before the birth of the infant):
Exclusion criteria:
- Infants whose parents are below the legal consenting age of the country.
- Infant’s whose mother has multiple pregnancies.
- Infant’s whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
- Infant’s whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant’s mother has been or will be exposed to an investigational or a non-investigational vaccine/product. Criteria applicable at enrolment (after the birth of the infant):
- Child in care.
- In case of multiple births.
- Infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result.
- Infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Criteria applicable at screening (before the birth of the infant):
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
2018-22-10
Actual study completion date
2018-22-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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