Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infanrix · 4 trials · 6 indications
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system.
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
Geometric mean concentrations are given in IU/mL.
Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Antibody titers were expressed as Geometric mean titers (GMTs)
Antibody titers were expressed as Geometric mean titers (GMTs)
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Antibody titers were expressed as Geometric mean titers (GMTs)
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
| Arm | Type | Description |
|---|---|---|
| INFANRIX+HIB/POLIORIX 1 GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| INFANRIX+HIB/POLIORIX 2 GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| CONTROL GROUP | ACTIVE_COMPARATOR | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| Rotarix Group | EXPERIMENTAL | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh. |
| Infanrix/Hib Single Injection Group | EXPERIMENTAL | Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™. |
| Infanrix + Hiberix Separate Injection Group | ACTIVE_COMPARATOR | Subjects received two separate injections, one of Infanrix™ and one of Hiberix™. |
| Menhibrix 1 Group | EXPERIMENTAL | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 1 Group\] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Menhibrix 2 Group\], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 2 Group\]. |
| ActHIB- Infanrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age. |
| Name | Type | Description |
|---|---|---|
| Infanrix+Hib™ | BIOLOGICAL | Intramuscular, one dose |
| Poliorix™ | BIOLOGICAL | Intramuscular, one dose |
| GSK Biologicals' liquid human rotavirus vaccine 444563 | BIOLOGICAL | Oral administration |
| Placebo | BIOLOGICAL | Oral administration |
| Infanrix™ | BIOLOGICAL | Intramuscular administration |
| Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) | BIOLOGICAL | Oral administration |
| Hiberix™ | BIOLOGICAL | Intramuscular injection, one dose |
| GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) | BIOLOGICAL | One dose in the booster phase as intramuscular injection |
| GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) | BIOLOGICAL | Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection |
| Infanrix® | BIOLOGICAL | One dose as intramuscular injection |
| ActHIB® | BIOLOGICAL | Three doses in the priming phase as intramuscular injection |
| Pediarix® | BIOLOGICAL | Three doses in the priming phase as intramuscular injection |
Inclusion Criteria: * A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. * Subjects who completed the full three-dose primary vaccination course in study NCT01086423. * Subjects who the investigator believes that their parent(s)/ Legally A...
Infanrix is a vaccine used for the prevention of infections caused by acellular pertussis, tetanus, diphtheria, Haemophilus influenzae type b, meningococcal infections, and rotavirus infections. It is being studied in children as young as 6 weeks old, with clinical trials conducted in the United States and China.
Infanrix is a vaccine that targets bacterial and viral pathogens, specifically acellular pertussis, tetanus, diphtheria, Haemophilus influenzae type b, meningococcal infections, and rotavirus. It works by stimulating the immune system to produce a protective response against these infectious agents.
Infanrix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's immunogenicity, safety, and efficacy in pediatric populations.
Infanrix is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All four clinical trials listed for Infanrix are Phase 3 studies that have been completed, with a total enrollment of 3,340 participants.
Infanrix has been studied in four completed Phase 3 clinical trials. These include NCT00614614, NCT00696423, NCT01171963, and NCT01449812. The trials evaluated the vaccine's immunogenicity and safety in children, with studies conducted in the United States and China, covering conditions such as meningococcal infections, acellular pertussis, and rotavirus infections.
Infanrix is not the same as GSK Vaccine 134612. In clinical trial NCT00614614, Infanrix is compared to GSK Vaccine 134612, which is a separate investigational vaccine. The study evaluates the immune response and safety of GSK Vaccine 134612 when given at 12-15 months or 15-18 months after priming with GSK Vaccine 792014.