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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01175083 | Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A | PHASE3 | COMPLETED | 300 | — | — | Jun 1, 2011 | May 23, 2013 | Jun 6, 2019 | 1 | Burkina Faso |
Antibodies have been assessed against the following vaccine pneumococcal serotypes: 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
| Arm | Type | Description |
|---|---|---|
| Tritanrix-HepB/Hib+Polio Sabin <6S Group | EXPERIMENTAL | Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group | ACTIVE_COMPARATOR | Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Synflorix 7-11S Group | EXPERIMENTAL | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 7-11NS Group | ACTIVE_COMPARATOR | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 12-23S Group | EXPERIMENTAL | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Synflorix 12-23NS Group | ACTIVE_COMPARATOR | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Name | Type | Description |
|---|---|---|
| GSK1024850A (Synflorix) | BIOLOGICAL | 2, 3 or 4 intramuscular injection |
| Tritanrix-HepB/Hib | BIOLOGICAL | Intramuscular injection, 4 doses |
| Polio Sabin | BIOLOGICAL | 4 oral doses |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * A male or female between, and including: * 8 ...