Table 1. Studies of DTPa-HBV-IPV/Hib conducted using the 3-5-11 mo vaccination schedule.
| Study NCT* (country) |
Design Endpoints |
Groups | Number of subjects (Total cohort) |
|---|---|---|---|
| DTPa-HBV-IPV-031 NCT01457495 (Slovakia)13-15 |
Open Immunogenicity and Safety |
DTPa-IPV/Hib + HBV | 156 |
| DTPa-HBV-IPV/Hib (1:1) | 156 | ||
| DTPa-HBV-IPV-054 NCT01457508 (Italy and Germany)15,16 |
Open Immunogenicity and Safety |
DTPa-HBV-IPV/Hib | 220 |
| DTPa-HBV-IPV + Hib (1:1) |
220 | ||
| DTPa-HBV-IPV-060 NCT01457560 (Italy)15 |
Open Immunogenicity and Safety |
DTPa-HBV-IPV/Hib (+OPV for dose 3) |
80 |
| DTPa-HBV-IPV-094 NCT01457547 (Finland, Italy, and Sweden)15,17 |
Single blind Immunogenicity and Safety |
DTPa-HBV-IPV/Hib | 246 |
| DTPa-HBV-IPV-Hib-SP (1:1) |
248 | ||
| Hib-MenC-TT-014/015 NCT00327184 (Italy, Finland)18 |
Open, randomized, controlled Immunogenicity and Safety |
Hib-MenC-TT + DTPa-HBV-IPV | 355 |
| MenC-TT + DTPa-HBV-IPV/Hib (1:1) |
354 | ||
| Esposito et al. (Italy)19 |
Double blind Immunogenicity and safety |
DTPa-HBV-IPV/Hib + PCV13 | 303 |
| DTPa-HBV-IPV/Hib + PCV7 (1:1) |
303 | ||
| Durando et al. (Italy)20 |
Open field trial Immunogenicity and safety |
DTPa-HBV-IPV/Hib | 43 |
| DTPa-HBV-IPV/Hib + PCV7 | 151 |
DTPa-HBV-IPV/Hib, Infanrix™ hexa ((GlaxoSmithKline Vaccines); DTPa-HBV-IPV, Infanrix™ penta (GlaxoSmithKline Vaccines); DTPa-HBV-IPV-Hib-SP, Hexavac™ (Sanofi Pasteur); Hib, Hiberix™ (GlaxoSmithKline Vaccines); Hib-MenC-TT, Menitorix™, (GlaxoSmithKline Vaccines); MenC-TT - NeisVac-C™, Baxter; OPV, oral polio vaccine; HBV, Engerix™ B (GlaxoSmithKline Vaccines); PCV7/13, Prevenar™/ Prevenar™13 (Pfizer); *If registered at www.clinicatrials.gov.