Diphtheria-Tetanus-Acellular Pertussis
Conditions
Keywords
Infants, Cord blood sample, Acellular pertussis, Boostrix, Colombia, Pregnant women
Brief summary
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.
Detailed description
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.
Interventions
OTHERBlood sample
Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 \[approximately 4-8 weeks of age\]).
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
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. * 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.
Exclusion criteria
Criteria applicable at screening (before the birth of the infant): * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN). | 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). | Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN. | At birth (Day 0) and before primary vaccination (between Day 28 and Day 56). | Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. |
| Anti-PT, anti-FHA and anti-PRN antibody concentrations. | At birth (Day 0) and before primary vaccination (between Day 28 and Day 56). | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL. |
Countries
Colombia
Outcome results
None listed