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Also known as MenHibrix (Hib-MenCY-TT)
MenHibrix · 2 trials · 2 indications
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...
MenHibrix is a vaccine developed for protection against Neisseria meningitidis and Haemophilus influenzae type b. It is studied in healthy infants and young children, with clinical trials enrolling participants from 6 weeks of age. The program targets the infectious disease therapeutic area.
MenHibrix is developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical development program for the vaccine, including Phase 2 and Phase 3 studies in the United States and Australia.
MenHibrix has been studied in Phase 3 clinical development. Two trials are recorded for the program, both of which are completed, with no active trials ongoing. The studies together enrolled 1,374 participants.
MenHibrix has been evaluated in two completed trials. NCT00359983 was a Phase 3 study of long-term antibody persistence after a fourth dose, enrolling 270 participants in the United States. NCT00134719 was a Phase 2 study comparing the vaccine to licensed Hib and meningococcal serogroup C conjugate vaccines, enrolling 1,104 participants in Australia.
Yes, MenHibrix is also known as Hib-MenCY-TT. The two names refer to the same vaccine candidate developed by GSK for Neisseria meningitidis and Haemophilus influenzae type b, and both names appear in the clinical trial records for the program.
The MenHibrix trials were randomized and used active-controlled designs, comparing the vaccine against licensed Hib and meningococcal serogroup C conjugate vaccines. Participants were healthy volunteers, including infants from 6 weeks of age and children from 22 months, and the studies were not double-blind.