Approval Probability
TA Base Rate
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Also known as Infanrix hexa
Infanrix hexa Vaccine · 3 trials · 6 indications
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Antibody titers were presented as geometric mean titers (GMTs).
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
| Arm | Type | Description |
|---|---|---|
| GSK217744 Group 1 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| GSK217744 Group 2 | EXPERIMENTAL | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. |
| INFANRIX HEXA PF GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| INFANRIX HEXA PC GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| CONTROL GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| Name | Type | Description |
|---|---|---|
| Infanrix hexa | BIOLOGICAL | Single dose, licensed formulation, intramuscular into right thigh |
| Prevenar 13 | BIOLOGICAL | Single co-administered dose, intramuscular into left thigh |
| GSK217744 | BIOLOGICAL | Single dose, investigational formulation A or B, intramuscular into right thigh |
| Infanrix hexa Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine. * A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination. * Subjects who the inves...
Infanrix hexa is a vaccine used to protect against tetanus, acellular pertussis, streptococcal infections, poliomyelitis, and hepatitis B. It is administered to infants to provide immunity against these infectious diseases. The vaccine is developed by GSK plc and is currently in Phase 3 clinical development.
Infanrix hexa is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in infants.
Infanrix hexa is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. GSK plc is conducting multiple Phase 3 trials to assess its safety and effectiveness in preventing infectious diseases.
Infanrix hexa has been studied in several completed clinical trials, including NCT00366366, NCT01248884, NCT01353703, and NCT02096263. These trials evaluated the vaccine's immunogenicity and safety in infants across different countries, with a total enrollment of 1,597 participants.
Infanrix hexa is a vaccine that works by stimulating the immune system to produce antibodies against the antigens for tetanus, acellular pertussis, streptococcal infections, poliomyelitis, and hepatitis B. This helps protect infants from these infectious diseases.
Infanrix hexa is also known as the DTPa-HBV-IPV/Hib vaccine, which combines diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b antigens. Clinical trials refer to it by this alternative name.