A Phase 4 interventional study of Blood sample in Diphtheria-Tetanus-Acellular Pertussis, sponsored by GlaxoSmithKline. Terminated at 1 site in Colombia. Open to participants aged Up to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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.
This study will assess the immunogenicity in infants (at birth and just prior to primary pertussis vaccination [i.e. diphtheria, tetanus and pertussis [DTP] vaccination] administered at 8 weeks of age), of a single Boostrix booster dose administered to their mothers during the second or third trimester as per routine practice in Bogota, Colombia.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 18 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Criteria applicable at screening (before the birth of the infant):
Criteria applicable at enrolment (after the birth of the infant):
Exclusion Criteria:
Criteria applicable at screening (before the birth of the infant):
Criteria applicable at enrolment (after the birth of the infant):
This study group will include infants whose mothers have received Boostrix during the second (21-27 weeks) and third trimester (above 28 weeks) of their pregnancy, as per routine practice.
Other: Blood sample
Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 \[approximately 4-8 weeks of age\]).
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time frame: 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).
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time frame: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
Time frame: At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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