Table 1.
Study groups and vaccine formulation.
| Day 1 | Day 30 | |||||
|---|---|---|---|---|---|---|
| Antigen dose |
||||||
| PT (μg) | FHA (μg) | PRN (μg) | DT (Lf) | TT (Lf) | ||
| aP Booster | ||||||
| aP1 | 1 | 1 | 2 | 0 | 0 | Td-pur |
| aP2 | 2 | 2 | 4 | 0 | 0 | Td-pur |
| aP4 | 4 | 4 | 8 | 0 | 0 | Td-pur |
| TdaP Booster | ||||||
| T5d2aP1* | 1 | 1 | 2 | 2 | 5 | Placebo |
| T5d2aP2 | 2 | 2 | 4 | 2 | 5 | Placebo |
| T5d2aP4* | 4 | 4 | 8 | 2 | 5 | Placebo |
| T5d4aP1 | 1 | 1 | 2 | 4 | 5 | Placebo |
| T5d4aP2 | 2 | 2 | 4 | 4 | 5 | Placebo |
| T5d4aP4 | 4 | 4 | 8 | 4 | 5 | Placebo |
| Comparator* | 8 | 8 | 2.5 | 2.5 | 5 | Placebo |
*
Selected groups for CMI analyses.
Licensed comparator is Boostrix (GSK). Td-pur: Licensed tetanus and diphtheria vaccine (Novartis Vaccines and Diagnostics)
aP: acellular pertussis; CMI: cell-mediated immunity; DT: diphtheria toxoid; FHA: filamentous hemagglutinin; Lf: limit of flocculation; PRN: pertactin; PT: pertussis toxin; TdaP: tetanus, diphtheria, acellular pertussis booster vaccine; TT: tetanus toxoid.