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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00514709 | Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants | PHASE3 | COMPLETED | 1,843 | — | — | Sep 1, 2007 | Apr 1, 2009 | Aug 2, 2016 | 7 | Philippines |
| NCT00348881 | Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants | PHASE3 | COMPLETED | 2,133 | — | — | Jun 1, 2006 | Jun 1, 2008 | Oct 22, 2013 | 4 | Philippines |
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | DTaP-Hep B-PRP-T + OPV vaccine group |
| Group 2 | EXPERIMENTAL | Tritanrix-HepB/Hib™ + OPV vaccine group |
| Group 1: DTaP-Hep B-PRP-T + OPV vaccine | EXPERIMENTAL | Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. |
| Group 2: Tritanrix-HepB/Hib™ + OPV vaccine | ACTIVE_COMPARATOR | Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| DTaP-HB PRP~T Combined Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular (IM) |
| DTaP-HB-PRP~T vaccine | BIOLOGICAL | 0.5 mL, IM |
| Oral Polio Vaccine | BIOLOGICAL | Oral co-administered with study vaccine. |
| DTaP-HB-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Oral poliomyelitis vaccine (OPV) | BIOLOGICAL | Oral co-administered with study vaccine. |
Inclusion Criteria: * Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive) * Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, an...