Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Hib-MenCY-TT vaccine (MenHibrix), Hib-MenCY-TT (MenHibrix®), Hib-MenCY-TT
Hib-MenCY-TT vaccine · 3 trials · 2 indications
Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.
Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.
Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
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 |
|---|---|---|
| HibCY Group | EXPERIMENTAL | Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19. |
| PedHIB Group | ACTIVE_COMPARATOR | Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19. |
| 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 (MenHibrix®) | BIOLOGICAL | 4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group. |
| Pediarix® | BIOLOGICAL | 3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group. |
| Rotarix® | BIOLOGICAL | 2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group. |
| Prevnar 13® | BIOLOGICAL | 4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group. |
| PedvaxHIB® | BIOLOGICAL | 3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group. |
| Havrix® | BIOLOGICAL | 2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group. |
| 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: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Wri...
The Hib-MenCY-TT vaccine is a combined vaccine developed by GSK plc (ticker: GSK) that targets Haemophilus influenzae type b and Neisseria meningitidis. It is designed to protect against these bacterial infections, which can cause serious diseases such as meningitis and pneumonia, particularly in infants and young children.
The Hib-MenCY-TT vaccine is used for immunization against Haemophilus influenzae type b and Neisseria meningitidis. It is intended for healthy infants and toddlers, with clinical trials including participants from 6 weeks of age, to prevent invasive diseases caused by these pathogens.
The Hib-MenCY-TT vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this combined vaccine.
The Hib-MenCY-TT vaccine is in Phase 2 of clinical development. It has completed two Phase 2 trials and one Phase 3 trial, but it is not approved and remains investigational.
The Hib-MenCY-TT vaccine has been studied in completed trials including NCT01978093, a Phase 3 study in the United States with 600 participants; NCT00129116, a Phase 2 study in Belgium and Germany with 388 participants; and NCT00127855, a Phase 2 dose-ranging study in Australia with 409 participants.
Yes, the Hib-MenCY-TT vaccine is also known as MenHibrix. Other names include Hib-MenCY-TT (MenHibrix) and Hib-MenCY-TT (MenHibrix®). These refer to the same combined vaccine developed by GSK.