Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK's investigational non-typeable Haemophilus influenzae and Moraxella catarrhalis multi-antigen vaccine adjuvanted with AS01E · 1 trial · 1 indication
Antibody concentrations as measured by ELISA (Enzyme-linked immunosorbent assay) and expressed as adjusted (ANCOVA model) GMCs in ELISA units per milliliter (EU/mL). Cut-off value for the assay is 153, 16, 8 and 28 EU/mL for Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibodies respectively. The ANCOVA model includes study group, smoking status (current or former), age category (50-59, 60-69, 70-80 years of age) and center as factors and the antibody concentration before Dose 1 as covariate. As per protocol set (PPS) sample size was not met in Sh\_NTHi\_Mcat\_3 and Sh\_NTHi-Mcat\_6 groups then timeframe was adapted as follows: At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181 in Sh\_NTHi-Mcat\_1 group and Day 91 in NTHi-Mcat group)
| Arm | Type | Description |
|---|---|---|
| Sh_NTHi-Mcat_1 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151. |
| Sh_NTHi-Mcat_3 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211. |
| Sh_NTHi-Mcat_6 Group | EXPERIMENTAL | Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301. |
| NTHi-Mcat Group | ACTIVE_COMPARATOR | Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61. |
| Shingrix-Only Group | EXPERIMENTAL | Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHI Mcat investigational vaccine. Only safety data were collected for these subjects. |
| Name | Type | Description |
|---|---|---|
| GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E | BIOLOGICAL | 2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm |
| Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A) | BIOLOGICAL | 2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh\_NTHi-Mcat\_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid of the non-dominant arm |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject prior to performance of any study specific proced...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |