Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infanrix-IPV+Hib · 2 trials · 6 indications
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.
An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).
| Arm | Type | Description |
|---|---|---|
| Infanrix-IPV+Hib Group | EXPERIMENTAL | Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh. |
| Infanrix IPV Group | ACTIVE_COMPARATOR | Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. |
| Name | Type | Description |
|---|---|---|
| Infanrix-IPV+Hib™ | BIOLOGICAL | Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh. |
| Infanrix™-IPV+Hib | BIOLOGICAL | Intramuscular, 3 doses |
| Infanrix™ IPV | BIOLOGICAL | Intramuscular, 3 doses |
| Hiberix™ | BIOLOGICAL | Intramuscular, 3 doses |
| Synflorix™ | BIOLOGICAL | Intramuscular, 3 doses |
| Rotarix™ | BIOLOGICAL | Oral, 2 doses |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 24 months of age at the time of vaccination. * Written informed co...
Infanrix-IPV+Hib is a vaccine developed by GSK plc for the prevention of Haemophilus influenzae type b, diphtheria, acellular pertussis, poliomyelitis, streptococcal infections, and tetanus. It is currently in Phase 3 clinical development and is intended for use in infants and toddlers.
Infanrix-IPV+Hib is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being studied for use in preventing several infectious diseases, including diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b.
Infanrix-IPV+Hib is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. All four clinical trials for this vaccine have been completed, with a total enrollment of 985 participants across studies conducted in China, Vietnam, and Russia.
Infanrix-IPV+Hib has been studied in four completed Phase 3 trials: NCT00964028, NCT01086423, NCT01577732, and NCT02858440. These trials assessed the vaccine's safety and immunogenicity in healthy infants and toddlers in China, Vietnam, and Russia. The trials were not randomized, double-blind, or controlled.
Infanrix-IPV+Hib is also referred to as Infanrix-IPV/Hib in clinical trial records. Both names refer to the same vaccine developed by GSK plc, which is being studied for the prevention of diphtheria, tetanus, acellular pertussis, poliomyelitis, and Haemophilus influenzae type b infections.