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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01171989 | Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose | PHASE2 | COMPLETED | 391 | — | — | Aug 18, 2010 | Dec 3, 2010 | Jan 21, 2020 | 9 | Poland |
| NCT01090453 | Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants | PHASE2 | COMPLETED | 480 | — | — | May 17, 2010 | Oct 11, 2011 | Aug 20, 2018 | 34 | Canada, France +1 |
| NCT00970307 | Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age | PHASE2 | COMPLETED | 421 | — | — | Aug 13, 2009 | Jan 27, 2010 | Jan 3, 2020 | 9 | Poland |
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
| Arm | Type | Description |
|---|---|---|
| GSK2202083A + SYNFLORIX GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| INFANRIX HEXA/MENJUGATE GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| GSK2202083A Group | EXPERIMENTAL | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
| Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
| INFANRIX HEXA + MENJUGATE GROUP | ACTIVE_COMPARATOR | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| INFANRIX HEXA + SYNFLORIX GROUP | ACTIVE_COMPARATOR | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| Name | Type | Description |
|---|---|---|
| GSK2202083A vaccine | BIOLOGICAL | Intramuscular, one dose. |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, one dose. |
| Menjugate™ | BIOLOGICAL | Intramuscular, one dose. |
| NeisVac-C™ | BIOLOGICAL | Intramuscular, one dose. |
| Synflorix™ | BIOLOGICAL | Intramuscular, one dose. |
| Prevenar 13® | BIOLOGICAL | 3 co-administered doses |
| Menjugate® | BIOLOGICAL | 3 co-administered doses |
| Rotarix™ | BIOLOGICAL | Oral, two doses |
| 10-valent pneumococcal vaccine (GSK 1024850A) | BIOLOGICAL | Intramuscular, three doses |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol. * Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primar...