Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Infanrix hexa™, Infanrix hexa ®, Infanrix hexa Vaccine, Infanrix™ hexa, Infanrix-Hexa, Infanrix™ hexa., Infanrix hexa.
INFANRIX HEXA · 7 trials · 7 indications
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
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 vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
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-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/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 |
|---|---|---|
| Infanrix hexa Group | EXPERIMENTAL | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pediarix Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pentacel Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| INFANRIX HEXA 6-10-14 GROUP | EXPERIMENTAL | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. |
| INFANRIX HEXA 2-4-6 GROUP | ACTIVE_COMPARATOR | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
| 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 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 | 3 doses administered intramuscularly in the right thigh. |
| Pediarix | BIOLOGICAL | 3 doses administered intramuscularly in the right thigh |
| ActHIB | BIOLOGICAL | 4 doses administered intramuscularly in the upper left thigh |
| Pentacel | BIOLOGICAL | 4 doses administered intramuscularly in the right thigh |
| Engerix-B | BIOLOGICAL | 2 or 3 doses administered intramuscularly in the upper left thigh |
| Infanrix | BIOLOGICAL | 1 dose administered intramuscularly in the right thigh |
| Hiberix | BIOLOGICAL | 1 dose administered intramuscularly in the left thigh |
| Prevnar13 | BIOLOGICAL | 3 doses administered intramuscularly in the lower left thigh |
| Rotarix | BIOLOGICAL | 2 doses administered orally |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, three doses |
| Infanrix-Hexa | BIOLOGICAL | - |
| Prevenar 13 | BIOLOGICAL | Single co-administered dose, intramuscular into left thigh |
| GSK217744 | BIOLOGICAL | Single dose, investigational formulation A or B, intramuscular into right thigh |
| Prevenar 13® | BIOLOGICAL | 3 co-administered doses, intramuscular into right thigh |
| Infanrix hexa Vaccine | BIOLOGICAL | - |
Inclusion Criteria: * Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born f...
Infanrix hexa is a vaccine used for immunization against hepatitis B, tetanus, acellular pertussis, poliomyelitis, and infections caused by Streptococcus. It is being studied in infants as young as 6 weeks of age for the prevention of these infectious diseases.
Infanrix hexa is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being investigated in Phase 3 clinical trials for use in pediatric populations.
Infanrix hexa is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. All completed trials for Infanrix hexa are Phase 3 studies, with no active trials currently ongoing.
Infanrix hexa has been studied in three completed Phase 3 trials. NCT01353703 evaluated its immunogenicity and safety in infants in India. Other trials, including NCT00307034 and NCT00652951, assessed co-administration with pneumococcal conjugate vaccines in European countries.
Infanrix hexa is a vaccine that works by stimulating the immune system to produce antibodies against several infectious agents. It contains antigens for hepatitis B, tetanus, acellular pertussis, poliovirus, and Haemophilus influenzae type b, providing protection against these diseases.
Yes, Infanrix hexa is also known as DTPa-HBV-IPV/Hib, which refers to its combination of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b antigens. This combination vaccine is designed for primary immunization of infants.