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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00359983 | Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB | PHASE3 | COMPLETED | 270 | — | — | Sep 1, 2006 | May 1, 2011 | Dec 16, 2016 | 21 | United States |
| NCT00134719 | Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines | PHASE2 | COMPLETED | 1,104 | — | — | Apr 11, 2005 | Feb 21, 2007 | Jul 19, 2018 | 3 | Australia |
Results up to 5 years after the fourth dose are presented.
Results up to 5 years after the fourth dose are presented.
Results up to 5 years after the fourth dose are presented.
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (\<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
| Arm | Type | Description |
|---|---|---|
| MenHibrix 4-dose group | EXPERIMENTAL | Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. |
| ActHIB 4-dose group | ACTIVE_COMPARATOR | Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study. |
| ActHIB 3-dose + MenHibrix 4th-dose group | EXPERIMENTAL | Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. |
| MenHibrix Group | EXPERIMENTAL | Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| ActHIB + Meningitec Group | ACTIVE_COMPARATOR | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. |
| ActHIB/PedvaxHIB Group | ACTIVE_COMPARATOR | Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. |
| Name | Type | Description |
|---|---|---|
| MenHibrix (Hib-MenCY-TT) | BIOLOGICAL | First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose |
| Hib conjugate vaccine (ActHIB) | BIOLOGICAL | First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose |
| Infanrix® Penta | BIOLOGICAL | One intramuscular dose at 2, 4 and 6 months of age |
| Prevenar® | BIOLOGICAL | One intramuscular dose at 2, 4 and 6 months of age |
| ActHIB® | BIOLOGICAL | One intramuscular dose at 2, 4 and 6 months of age |
| Meningitec® | BIOLOGICAL | One intramuscular dose at 2, 4 and 6 months of age |
| M-M-R®II | BIOLOGICAL | One subcutaneous dose at 12-15 months of age |
| Varivax® | BIOLOGICAL | One subcutaneous dose at 12 to 15 months of age |
| PedvaxHIB® | BIOLOGICAL | One intramuscular dose at 12 to 15 months of age |
Inclusion Criteria: * Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows: * Year 1: 22 to 36 months of age. * Year 3: 44 to 60 months of age. * Year 5: 5 years p...