Table 1.
Description of the studies
| Study (country) | Study designation | Design | Age of subjects | Vaccination schedule | Time of blood sample collection | Reference |
|---|---|---|---|---|---|---|
| A, phase II (Philippines) | 759346/001-002, NCT00317174 | Open, randomized | 6–10 wk | 3 Doses of DTPw-HBV/Hib-MenAC (TT conjugate)a or DTPw-HBV + Hibb,c | 1 mo after completion of vaccination and at 10 mo in a randomized subset | 5 |
| B, phase II (Ghana) | 104430/ISRCTN3575408 | Double blind, randomized | 6–10 wk | Primary: 3 doses of DTPw-HBV/Hib-MenAC (TT-conjugate)a or DTPw-HBV/Hiba,c | 1 mo after completion of primary vaccination, prior to, and 1 month after booster | 11 |
| 12 mo | Booster: 1/5 dose of MenAC (PS)d | |||||
| C, phase III (Thailand) | 104727, NCT00136604 | Partially blinded, controlled | Infancy | Primery: 3 doses of DTPw-HBV/Hib-MenAC (TT-conjugate)a or DTPw-HBV/Hiba,c | Prior to and 1 month after booster | 15 |
| 15–24 mo | Booster: DTPw-HBV/Hib-MenAC (TT conjugate)a | |||||
| D, phase II (Denmark) | 104702, NCT00126945 | Randomized, partially blinded | 15–19 yr | 1 Dose of investigational MenACWY (TT conjugate) or MenACWY (PS)e | Prior to and 1 month after vaccination | 23 |
| E, phase II (Germany and Austria) | 104703, NCT00126984 | Randomized, partially blinded | 12–14 mo or 3–5 y | 1 Dose of investigational MenACWY (TT conjugate), MenC (CRM197 conjugate)f (age 12–14 mo), or MenACWY (PS)e (age 3–5 yr) | Prior to and 1 month after vaccination | 17 |
a
Both vaccines were mixed extemporaneously.
b
Both vaccines were administered separately.
c
TritanrixHepB (GSK)/Hiberix (GSK).
d
Mencevax AC (GSK).
e
Mencevax ACWY (GSK).
f
Meningitec (Wyeth).