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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02447432 | A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants | PHASE3 | COMPLETED | 320 | — | — | Jun 11, 2015 | May 22, 2016 | Aug 2, 2018 | 1 | Bangladesh |
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
| Arm | Type | Description |
|---|---|---|
| 10Pn_4d Group | EXPERIMENTAL | Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). |
| 10Pn Group | ACTIVE_COMPARATOR | Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). |
| Name | Type | Description |
|---|---|---|
| Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation) | BIOLOGICAL | 4 doses by intramuscular injection in the right left anterolateral thigh |
| Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation) | BIOLOGICAL | 4 doses by intramuscular injection in the right anterolateral thigh |
| DTPw-HBV/Hib | BIOLOGICAL | 3 doses by intramuscular injection in the left anterolateral thigh |
Inclusion Criteria: * Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits). * A male or female between, and including 6-10 we...