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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00808444 | Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age | PHASE3 | COMPLETED | 466 | — | — | Jan 5, 2009 | Nov 2, 2009 | Aug 17, 2018 | 5 | Malaysia, Singapore |
| NCT00652951 | Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib | PHASE3 | COMPLETED | 780 | — | — | Apr 1, 2008 | Dec 1, 2010 | Jun 26, 2019 | 1 | Netherlands |
| NCT00307034 | Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule | PHASE3 | COMPLETED | 351 | — | — | Jan 1, 2006 | Jan 25, 2007 | Jun 8, 2018 | 8 | Denmark, Norway +2 |
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
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 |
|---|---|---|
| Synflorix Clinical Lot & Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| Synflorix Commercial Lot Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| Synflorix + Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid. |
| Synflorix + Pediacel Group | EXPERIMENTAL | Subjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid. |
| Prevenar + Pediacel Group | ACTIVE_COMPARATOR | Subjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid. |
| 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 |
|---|---|---|
| Pneumococcal conjugate vaccine GSK1024850A (different lots) | BIOLOGICAL | Intramuscular injection, 3 doses |
| Infanrix hexa | BIOLOGICAL | Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore |
| Infanrix-IPV/Hib | BIOLOGICAL | Intramuscular injection, only for Visit 2 in Singapore |
| Rotarix | BIOLOGICAL | Oral, 2 doses |
| GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™) | BIOLOGICAL | Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Infanrix™ hexa. | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Pediacel™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Prevenar™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| 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: * Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * Written or oral, signed or thumb-p...