Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hib-MenCY-TT vaccine · 2 trials · 2 indications
The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
| Arm | Type | Description |
|---|---|---|
| MenHibrix Formulation 1 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| MenHibrix Formulation 2 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| MenHibrix Formulation 3 Group | EXPERIMENTAL | Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| Menjugate Group | ACTIVE_COMPARATOR | Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| ActHIB Group | ACTIVE_COMPARATOR | Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age. |
| Menhibrix F1/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F2/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menhibrix F3/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menitorix/Infanrix-penta Group | EXPERIMENTAL | Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Menjugate/Infanrix-hexa Group | ACTIVE_COMPARATOR | Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively. |
| Name | Type | Description |
|---|---|---|
| Hib-MenCY-TT vaccine (MenHibrix) | BIOLOGICAL | Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively |
| Meningitec® | BIOLOGICAL | Three doses were administered IM in right lower thigh at Months 0,2 and 4. |
| ActHIB® | BIOLOGICAL | Three doses were administered IM in left thigh at Months 0,2 and 4. |
| Infanrix® Penta | BIOLOGICAL | Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively. |
| Prevenar® | BIOLOGICAL | Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively. |
| Mencevax® ACWY | BIOLOGICAL | One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster. |
| PRP (Polyribosyl Ribitol Phosphate) | BIOLOGICAL | One dose was administered IM in deltoid region of left arm at Month 10 as booster. |
| Hib-MenCY-TT vaccine | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Hib-MenC-TT vaccine | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Menjugate ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh. |
| Infanrix penta ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. |
| Infanrix hexa ® | BIOLOGICAL | Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh. |
Inclusion criteria: * A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical ex...
Hib-MenCY-TT is an investigational vaccine being developed for the prevention of diseases caused by Neisseria Meningitidis and Haemophilus Influenzae Type b. It is designed for use in infants and toddlers, with clinical trials enrolling healthy participants as young as 6 weeks of age.
Hib-MenCY-TT targets two bacterial pathogens: Neisseria Meningitidis, which causes meningococcal disease, and Haemophilus Influenzae Type b, which causes severe bacterial infections including meningitis. The vaccine combines antigens from both organisms to elicit an immune response.
Hib-MenCY-TT is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK Biologicals conducted the clinical trials for this vaccine candidate.
Hib-MenCY-TT is in Phase 3 clinical development. It has completed two Phase 2 trials and one Phase 3 trial, all of which are finished. The drug remains investigational and has not been approved by regulatory authorities.
Hib-MenCY-TT has been studied in three completed trials: NCT00127855, a Phase 2 dose-ranging study in Australia with 409 participants; NCT00129116, a Phase 2 formulation comparison in Belgium and Germany with 388 participants; and NCT01978093, a Phase 3 trial in the United States with 600 participants comparing it to PedvaxHIB.
Yes, Hib-MenCY-TT is also known as MenHibrix. The Phase 3 trial NCT01978093 explicitly refers to the vaccine as MenHibrix, indicating that these names are used interchangeably for the same vaccine candidate.