Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DTPa-HBV-IPV/Hib · 6 trials · 8 indications
Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = \> 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
An AE was defined as 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.
| Arm | Type | Description |
|---|---|---|
| Infanrix Hexa Group | EXPERIMENTAL | Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally. |
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| DTPa 1 Group | EXPERIMENTAL | - |
| DTPa 2 Group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DTPa-HBV-IPV/Hib | BIOLOGICAL | 1 intramuscular injection (3rd study vaccine dose) |
| DTPa-IPV/Hib vaccine | BIOLOGICAL | 3 intramuscular injections (1st, 2nd and 4th vaccine dose) |
| DTPa-HBV-IPV/Hib vaccine | BIOLOGICAL | Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age. |
| EngerixTM-B | BIOLOGICAL | The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age. |
| DTPa-HBV-IPV/Hib (Infanrix hexa™) | BIOLOGICAL | Three doses administered intramuscularly |
| OPV | BIOLOGICAL | One dose administered orally |
| DTPa-HBV-IPV (Infanrix penta™) | BIOLOGICAL | Three doses administered intramuscularly |
| Hib (Hiberix™) | BIOLOGICAL | Three doses administered intramuscularly |
| DTPa-HBV-IPV/Hib (Infanrix-hexa™) | BIOLOGICAL | 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 |
| DTPa-IPV/Hib (Infanrix-IPV/Hib™) | BIOLOGICAL | 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 |
| HBV (Engerix™-B) | BIOLOGICAL | 3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8 |
Inclusion criteria * Subjects must have been enrolled in the Rota-028 study. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 11 and 17 wee...
DTPa-HBV-IPV/Hib is an investigational combination vaccine being studied for use in preventing Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b infections. It is designed for administration to infants, with clinical trials evaluating its safety and immunogenicity in this population.
DTPa-HBV-IPV/Hib is being developed by GSK plc, a biopharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company has sponsored multiple clinical trials to evaluate the vaccine's safety and immunogenicity.
DTPa-HBV-IPV/Hib is in Phase 3 clinical development. It remains investigational and has not been approved by regulatory authorities. Completed trials include both Phase 2 and Phase 3 studies assessing the vaccine in infant populations.
DTPa-HBV-IPV/Hib has been studied in five completed clinical trials, including NCT00289796, NCT00325143, NCT01457495, and NCT01457508. These trials evaluated the vaccine's safety and immunogenicity in infants, with total enrollment of 1,093 participants across the studies.
Yes, DTPa-HBV-IPV/Hib is also known as DTPa-HBV-IPV+Hib. Both names refer to the same investigational combination vaccine being developed by GSK plc for prevention of Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b infections.
DTPa-HBV-IPV/Hib is a combination vaccine intended to stimulate an immune response against multiple diseases. It contains components targeting Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b, along with other vaccine antigens, to help protect infants from these infections.