The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00109330).
Subjects were previously vaccinated with either Boostrix or a control Td vaccine in study NCT00109330. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 1 (Day 0) and subjects will be observed till Visit 2 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 1) and one month after vaccination (Visit 2) for antibodies estimation. This summary has been updated following Protocol amendment 2 dated 03 October 2013. The protocol is being amended to facilitate enrolment by: * \- Extending the window period for re-vaccination from ± 6 months to ± 300 days from the Year 10 time point. * \- Extending the recruitment period from 6 months to 14 months. The format of non-inferiority criterion of the first co-primary objective has been updated to keep it aligned with the format of non-inferiority criterion of the second co-primary objective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
165
Single dose intramuscular administration.
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Tempe, Arizona, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Fullerton, California, United States
GSK Investigational Site
Rolling Hills Estates, California, United States
GSK Investigational Site
Golden, Colorado, United States
GSK Investigational Site
Norwich, Connecticut, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Bardstown, Kentucky, United States
...and 10 more locations
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time frame: At Month 1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Concentrations were expressed in geometric mean concentrations (GMCs).
Time frame: At Month 1
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Time frame: At Month 0
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.
The cut-off of the assay was ≥ 1.0 IU/mL.
Time frame: At Month 0 and Month 1
Anti-D and Anti-T Antibody Concentrations.
Concentrations were expressed as GMCs.
Time frame: At Month 0 and Month 1
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).
Concentrations were expressed in geometric mean concentrations (GMCs).
Time frame: At Month 0
Number of Subjects With a Booster Response to Anti-D and Anti-T.
Booster response to anti-D and anti-T antigens was defined as: * for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination, * for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Time frame: At Month 1
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Booster response to pertussis antigens was defined as: * for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination; * for initially seropositive subjects with anti-body concentration \< four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination; * for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.
Time frame: At Month 1.
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.
Time frame: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Solicited General Symptoms.
The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.
Time frame: During the 4 days (Day 0 - 3) follow-up period after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: During the 31 days (Day 0 - 30) after vaccination.
Number of Subjects With Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 to 31 days post-vaccination.
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