Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01309646 | Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine | PHASE3 | COMPLETED | 454 | — | — | Mar 4, 2011 | Feb 24, 2012 | Nov 27, 2019 | 11 | South Korea |
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, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses 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+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. |
| 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 | 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: * A male or female between, and including, 42 and 69 days of age at the time of the first vaccination. * Born after a gestation period of 37 to 42 weeks inclusive. * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply wi...