Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine · 1 trial · 2 indications
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
| Arm | Type | Description |
|---|---|---|
| MenHibrix Group | EXPERIMENTAL | Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh. |
| ActHIB Group | ACTIVE_COMPARATOR | During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively. |
| Menomune Group | ACTIVE_COMPARATOR | Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region. |
| ActHIB/Menhibrix Group | EXPERIMENTAL | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. |
| ActHIB/ActHIB Group | EXPERIMENTAL | Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine | BIOLOGICAL | Primary phase: 3 IM doses Booster phase: 1 IM dose |
| ActHIB | BIOLOGICAL | Primary phase: 3 IM doses Booster phase: 1 IM dose |
| Pediarix | BIOLOGICAL | Primary phase: 3 IM doses |
| Prevnar | BIOLOGICAL | Primary phase: 3 IM doses Booster phase: 1 IM dose |
| Menomune | BIOLOGICAL | Primary phase: 1 SC dose |
Inclusion Criteria: * For Groups A and B * Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written info...
It is an investigational combination vaccine developed by GSK Biologicals, part of GSK plc, that combines Haemophilus influenzae type b with Neisseria meningitidis serogroups C and Y, using tetanus toxoid as the carrier protein. It is being studied for protection against Haemophilus influenzae type b disease.
It is being studied for immunization against Haemophilus influenzae type b, with additional components directed at Neisseria meningitidis serogroups C and Y. The vaccine is intended for healthy infants, with trial enrollment starting at 6 weeks of age.
The vaccine is developed by GSK Biologicals, the vaccine division of GSK plc, which trades under the ticker GSK. GSK Biologicals is the sponsor of the clinical program for this Hib-MenCY-TT conjugate vaccine candidate.
The Hib-MenCY-TT vaccine is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active.
The vaccine was evaluated in trial NCT00129129, titled Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine. This completed Phase 2 study enrolled 756 healthy infants in the United States, used an active-controlled design, and included randomization.