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Also known as dTPa-IPV vaccine
Boostrix Polio · 1 trial · 1 indication
Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6. |
| Boostrix Polio → Cervarix Group | EXPERIMENTAL | Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 1, 2 and 7. |
| Cervarix + Boostrix Polio Group | EXPERIMENTAL | Subjects who received GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. |
| Name | Type | Description |
|---|---|---|
| Boostrix ® Polio | BIOLOGICAL | One dose of vaccine administered intramuscularly |
| GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively |
Inclusion Criteria: * Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 10 and 18 years of age at the time of the first...
Boostrix Polio is a vaccine developed by GSK plc (ticker GSK) that combines booster immunization against diphtheria, tetanus, pertussis, and poliovirus. It is given as a booster dose to maintain protection against these infectious diseases. The product is also known as Boostrix ® Polio.
Boostrix Polio is used for booster vaccination against diphtheria, tetanus, pertussis, and polio. It has been studied in a Phase 3 trial in healthy female subjects aged 10 years and older for co-administration with a human papillomavirus (HPV) vaccine to prevent infections and papillomavirus-related conditions.
Boostrix Polio is made by GSK plc, which trades under the ticker GSK. GSK is the developer of the vaccine and conducted the clinical trial evaluating its co-administration with an HPV vaccine.
Boostrix Polio has been evaluated in a Phase 3 clinical trial. The trial, NCT00426361, is completed. The vaccine is not described as approved in the available information and remains an investigational product in the context of the trial data.
Boostrix Polio has been studied in one completed Phase 3 trial, NCT00426361, titled Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects. The trial enrolled 751 participants across France, Germany, and Spain.
Yes, Boostrix Polio and Boostrix ® Polio refer to the same vaccine. Boostrix ® Polio is the registered trademark name used by GSK plc. Both names identify the combined booster vaccine against diphtheria, tetanus, pertussis, and poliovirus.