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Also known as GSK Biologicals' 10-valent pneumococcal conjugate vaccine.
GSK Biologicals' 10-valent pneumococcal conjugate vaccine · 1 trial · 1 indication
A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs). The results presented for the Group 1 correspond to the primary outcome.
| Arm | Type | Description |
|---|---|---|
| 2-dose group | EXPERIMENTAL | Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age. |
| Comparator group | EXPERIMENTAL | Subjects receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine at 2-3-4-11 months of age, co-administered with DTPa-combined vaccine (Infanrix hexa or Infanrix IPV/Hib) at 2-4-11 months of age. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' 10-valent pneumococcal conjugate vaccine. | BIOLOGICAL | Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule). |
| Infanrix hexa. | BIOLOGICAL | Intramuscular injection, 3 doses (2-4-11 months of age schedule). |
| Infanrix-IPV/Hib. | BIOLOGICAL | Intramuscular injection, 3 doses (2-4-11 months of age schedule). |
Inclusion criteria: * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination. * Written informed consent o...