Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Boostrix · 9 trials · 4 indications
A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations \<0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.
A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.
A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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)
Concentrations were expressed in geometric mean concentrations (GMCs).
Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)
Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated
Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: \< 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.
Booster response was defined as: for subjects with pre-vaccination antibody concentration \< 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL (S+, \<4\*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4\*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).
A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (\<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and \< 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.
| Arm | Type | Description |
|---|---|---|
| dTpa group | EXPERIMENTAL | Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1. |
| Boostrix Group 2 | EXPERIMENTAL | Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study. |
| Boostrix Group 1 | ACTIVE_COMPARATOR | Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study. |
| Boostrix Group | EXPERIMENTAL | Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) |
| Decavac Group | ACTIVE_COMPARATOR | Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) |
| Adacel Group | ACTIVE_COMPARATOR | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423). |
| Control group | ACTIVE_COMPARATOR | Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Boostrix | BIOLOGICAL | One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group. |
| Boostrix™ | BIOLOGICAL | Single-dose administered intramuscularly in the deltoid region of non-dominant arm. |
| Boostrix® | BIOLOGICAL | Intramuscular, single dose. |
| Decavac™ | BIOLOGICAL | Intramuscular, single dose. |
| Taking of blood samples | PROCEDURE | No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination. |
| Adacel | BIOLOGICAL | A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study. |
| Chinese DT vaccine | BIOLOGICAL | - |
| ADACEL® | BIOLOGICAL | Sanofi Pasteur |
| GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine | BIOLOGICAL | Intramuscular, single |
| GSK Biologicals' IPV vaccine | BIOLOGICAL | Intramuscular, single dose |
| Revaxis® | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female four years of age and older. * Written informed consent obtained from the subject/from the parent(s)/adopti...
Boostrix is a vaccine used for the prevention of diphtheria, tetanus, and acellular pertussis (whooping cough). It is indicated for booster immunization against these diseases in individuals, typically administered to older children, adolescents, and adults. The vaccine is developed by GSK plc and is currently in Phase 3 clinical development.
Boostrix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and immunogenicity of Boostrix in various populations, including children, adolescents, and adults, across multiple countries.
Boostrix is in Phase 3 clinical development. All four completed clinical trials for Boostrix are Phase 3 studies, which are designed to assess the vaccine's safety, immunogenicity, and efficacy in preventing diphtheria, tetanus, and acellular pertussis. The vaccine is investigational and not yet approved for public use.
Boostrix has been studied in four completed Phase 3 clinical trials, including NCT00452686, NCT01277705, NCT01988857, and NCT03311659. These trials evaluated the vaccine's safety and immunogenicity in healthy children, adolescents, and adults in countries such as China, Vietnam, and Russia, with a total enrollment of 4,291 participants.
Boostrix is not FDA approved. It is an investigational vaccine currently in Phase 3 clinical development. While the clinical trials have been completed, the vaccine has not yet received regulatory approval from the FDA or other health authorities. It remains under evaluation for safety and efficacy.