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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...
GSK Biologicals' 10-valent pneumococcal conjugate vaccine is an investigational vaccine developed by GSK plc for infections caused by Streptococcus pneumoniae. It is designed to protect against ten pneumococcal serotypes and was studied in a Phase 3 clinical trial evaluating a two-dose schedule in healthy infants.
It is being developed for the prevention of streptococcal infections, specifically those caused by Streptococcus pneumoniae. The Phase 3 study enrolled healthy infants to assess safety and immune response when the vaccine was given as a two-dose schedule.
The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division associated with this candidate, and the company sponsored the Phase 3 trial conducted across Denmark, Norway, Slovakia, and Sweden.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine remains investigational and has not been approved for use; the completed study evaluated safety and immunogenicity rather than serving as a regulatory approval trial.
It was studied in NCT00307034, a completed Phase 3 trial titled Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule. The randomized, controlled study enrolled 351 healthy infants aged 8 weeks and older in Denmark, Norway, Slovakia, and Sweden.