Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01738477 | Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults | PHASE3 | COMPLETED | 165 | — | — | Jan 31, 2013 | Apr 2, 2014 | Jun 6, 2018 | 20 | United States |
| NCT00835237 | Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine. | PHASE3 | COMPLETED | 1,332 | — | — | Feb 17, 2009 | Oct 15, 2009 | Jan 3, 2020 | 24 | United States |
| NCT00406562 | Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age. | PHASE3 | COMPLETED | 30 | — | — | Jan 1, 2007 | Feb 1, 2007 | Oct 27, 2016 | 1 | China |
| NCT01277705 | Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis® | PHASE3 | COMPLETED | 806 | — | — | Jan 1, 2002 | Apr 1, 2002 | Sep 7, 2016 | - | — |
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)
| Arm | Type | Description |
|---|---|---|
| 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) |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Group C | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Boostrix | BIOLOGICAL | Single dose intramuscular administration. |
| Boostrix® | BIOLOGICAL | Intramuscular, single dose. |
| Decavac™ | BIOLOGICAL | Intramuscular, single dose. |
| GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine | BIOLOGICAL | Intramuscular, single |
| Boostrix™ | BIOLOGICAL | Intramuscular, single dose |
| GSK Biologicals' IPV vaccine | BIOLOGICAL | Intramuscular, single dose |
| Revaxis® | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). * Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT001...