Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infanrix hexa · 6 trials · 8 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.
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.
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).
| 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. |
| Synflorix Clinical Lot & Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| Synflorix Commercial Lot Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| Synflorix + Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid. |
| Synflorix + Pediacel Group | EXPERIMENTAL | Subjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid. |
| Prevenar + Pediacel Group | ACTIVE_COMPARATOR | Subjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid. |
| 2-dose group | EXPERIMENTAL | Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age. |
| Comparator group | EXPERIMENTAL | Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-3-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age. |
| GSK217744 Group 1 | EXPERIMENTAL | Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively. |
| GSK217744 Group 2 | EXPERIMENTAL | Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively. |
| 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 |
| Pneumococcal conjugate vaccine GSK1024850A (different lots) | BIOLOGICAL | Intramuscular injection, 3 doses |
| Infanrix-IPV/Hib | BIOLOGICAL | Intramuscular injection, only for Visit 2 in Singapore |
| GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™) | BIOLOGICAL | Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Infanrix™ hexa. | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Pediacel™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Prevenar™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| GSK Biologicals' 10-valent pneumococcal conjugate vaccine. | BIOLOGICAL | Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule). |
| Infanrix hexa. | BIOLOGICAL | Intramuscular injection, 3 doses (2-4-11 months of age schedule). |
| Infanrix-IPV/Hib. | BIOLOGICAL | Intramuscular injection, 3 doses (2-4-11 months of age schedule). |
| Prevenar 13® | BIOLOGICAL | 3 co-administered doses, intramuscular into right thigh |
| GSK217744 | BIOLOGICAL | 3 doses, intramuscular into left thigh |
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 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.