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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00880477 | Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine | PHASE3 | COMPLETED | 140 | — | — | Jan 1, 2001 | Nov 1, 2002 | Sep 7, 2016 | - | — |
| NCT01457560 | Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine | PHASE3 | COMPLETED | 80 | — | — | Feb 1, 2000 | Apr 1, 2001 | Aug 5, 2016 | - | — |
| NCT01457508 | Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately | PHASE3 | COMPLETED | 440 | — | — | Jan 1, 1999 | Mar 1, 2000 | Jun 16, 2017 | - | — |
| NCT00289796 | Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine | PHASE2 | COMPLETED | 121 | — | — | Jul 1, 2004 | Dec 1, 2006 | Feb 8, 2017 | 1 | Germany |
| NCT01457495 | Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly | PHASE2 | COMPLETED | 312 | — | — | Sep 1, 1998 | Sep 1, 1999 | Jun 16, 2017 | - | — |
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = \> 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | EXPERIMENTAL | - |
| Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh. |
| DTPa 1 Group | EXPERIMENTAL | - |
| DTPa 2 Group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DTPa-HBV-IPV/Hib vaccine | BIOLOGICAL | Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age. |
| DTPa-IPV/Hib vaccine | BIOLOGICAL | Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age. |
| EngerixTM-B | BIOLOGICAL | The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age. |
| DTPa-HBV-IPV/Hib (Infanrix hexa™) | BIOLOGICAL | Three doses administered intramuscularly |
| OPV | BIOLOGICAL | One dose administered orally |
| DTPa-HBV-IPV (Infanrix penta™) | BIOLOGICAL | Three doses administered intramuscularly |
| Hib (Hiberix™) | BIOLOGICAL | Three doses administered intramuscularly |
| DTPa-HBV-IPV/Hib | BIOLOGICAL | GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine |
| DTPa-HBV-IPV/Hib (Infanrix-hexa™) | BIOLOGICAL | 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 |
| DTPa-IPV/Hib (Infanrix-IPV/Hib™) | BIOLOGICAL | 3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8 |
| HBV (Engerix™-B) | BIOLOGICAL | 3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8 |
Inclusion Criteria: Inclusion criteria for enrolment at birth * Written informed consent obtained from the parents or guardians of the subject. * A male or female infant born after a normal gestation period (between 36 and 42 weeks). * Born to a mother seronegative for HBsAg. * Free of obvious hea...