Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infanrix-IPV/Hib · 4 trials · 9 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.
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.
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.
| 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 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. |
| Preterm I Group | EXPERIMENTAL | Children born after a gestation period of 27-30 weeks |
| Preterm II Group | EXPERIMENTAL | Children born after a gestation period of 31-36 weeks |
| Full term Group | ACTIVE_COMPARATOR | Children born after a gestation period of more than 36 weeks |
| 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 | Intramuscular, three doses |
| Infanrix Hib™ | BIOLOGICAL | Intramuscular, three doses |
| Poliorix™ | BIOLOGICAL | Intramuscular, three doses |
| Infanrix™-IPV/Hib | BIOLOGICAL | Intramuscular, three doses |
| GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A) | BIOLOGICAL | Single dose, intramuscular injection |
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 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.