Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Infanrix hexa ®
DTPa-HBV-IPV/Hib vaccine · 8 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 vaccine | BIOLOGICAL | - |
| 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) |
| 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: * A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. * Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is a...
The DTPa-HBV-IPV/Hib vaccine is a combination vaccine developed by GSK plc for protection against multiple infectious diseases in infants. It is designed to immunize against diphtheria, Haemophilus influenzae type b, and hepatitis B, among other components indicated in its clinical program. It is a vaccine modality studied in Phase 3 clinical trials.
The DTPa-HBV-IPV/Hib vaccine is used for immunization against diphtheria, Haemophilus influenzae type b, and hepatitis B. Clinical trials have also listed pertussis, tetanus, and poliomyelitis among the conditions studied. It is intended for infants, with trial enrollment starting at 6 to 12 weeks of age.
The DTPa-HBV-IPV/Hib vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this combination vaccine. The vaccine is also known by the brand name Infanrix hexa.
The DTPa-HBV-IPV/Hib vaccine has been studied in Phase 3 clinical trials, with one Phase 2 trial also conducted. All five listed trials are completed, and none are currently active. It is an investigational combination vaccine in clinical development.
The DTPa-HBV-IPV/Hib vaccine has been evaluated in completed trials including NCT01457560, NCT01457508, NCT01457495, and NCT00880477. These trials assessed immunogenicity and safety in infants, with total enrollment across the program of 1,093 participants. The studies were randomized and double-blind.
Yes, the DTPa-HBV-IPV/Hib vaccine is also known as Infanrix hexa. Other listed alternative names include DTPa-HBV-IPV+Hib and DTPa-HBV-IPV/Hib (Infanrix hexa). These names refer to the same GSK combination vaccine.