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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00534833 | Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ | PHASE3 | COMPLETED | 362 | — | — | Sep 1, 2007 | Mar 1, 2009 | Nov 21, 2013 | 2 | Philippines |
| NCT00343889 | Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine | PHASE3 | COMPLETED | 379 | — | — | Aug 1, 2006 | Apr 1, 2008 | Dec 10, 2013 | 2 | Philippines |
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | DTaP-Hep B-PRP-T + OPV vaccine group |
| Group 2 | ACTIVE_COMPARATOR | Tritanrix-HepB/Hib™ + OPV vaccine group |
| Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine | EXPERIMENTAL | Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with Oral Polio Vaccine (OPV), 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 Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| DTaP-HB-PRP~T vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ | BIOLOGICAL | 0.5 mL, Intramuscular |
| Oral Polio Vaccine | BIOLOGICAL | 0.5 mL, Oral |
| DTaP-HB-PRP~T vaccine + OPV | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tritanrix-HepB/Hib™ + OPV vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive) * Participated in the AL203 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 * I...