Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Infanrix™ IPV
Infanrix-IPV/Hib · 5 trials · 8 indications
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
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).
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-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| DTPa-IPV/Hib Group | EXPERIMENTAL | All subjects receive three doses of primary vaccination of the study vaccine, Infanrix-IPV/Hib (DTPa-IPV/Hib), at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side. |
| 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. |
| INFANRIX-IPV+HIB 1 GROUP | EXPERIMENTAL | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. |
| INFANRIX-IPV+HIB 2 GROUP | EXPERIMENTAL | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. |
| INFANRIX-HIB+POLIORIX GROUP | ACTIVE_COMPARATOR | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. |
| INFANRIX-IPV/HIB M2-M3-M4 GROUP | EXPERIMENTAL | Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh. |
| INFANRIX-IPV/HIB M3-M4-M5 GROUP | EXPERIMENTAL | Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh. |
| Name | Type | Description |
|---|---|---|
| Infanrix-IPV/Hib | BIOLOGICAL | Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side. |
| 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 |
| Infanrix-IPV/Hib™ | BIOLOGICAL | Intramuscular, three doses |
| Infanrix Hib™ | BIOLOGICAL | Intramuscular, three doses |
| Poliorix™ | BIOLOGICAL | Intramuscular, three doses |
| Infanrix™-IPV/Hib | BIOLOGICAL | Intramuscular, three doses |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representatives \[LARs\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female child between 3 and 4 months of age at the time of the first vaccination. * Written informed c...
Infanrix-IPV/Hib is a combination vaccine used to protect against diphtheria, tetanus, acellular pertussis, poliomyelitis, and Haemophilus influenzae type b. It is given to infants and toddlers as a multi-dose vaccination course, with a booster dose, to prevent these infectious diseases.
Infanrix-IPV/Hib is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK Biologicals is the specific unit responsible for the vaccine.
Infanrix-IPV/Hib is in Phase 3 clinical development. The vaccine has been evaluated in completed Phase 3 trials, and it is not described as approved in the available information.
Infanrix-IPV/Hib has been studied in completed Phase 3 trials including NCT02858440 in Russia, NCT01577732 in Vietnam, NCT01309646 in South Korea, and NCT01086423 in China. These trials enrolled healthy infants and toddlers to assess immunogenicity and safety.