Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB213503 lot 1 · 1 trial · 3 indications
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).
GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).
GMTs were measured by Neutralization assay and expressed in titers.
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 0.1 international units per milliliter (IU/mL)\] with an increase of at least four times the cut-off one month after vaccination \[post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL\]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.
Vaccine response defined as: For initially seronegative subjects \[pre-booster antibody concentration below (\<) cut-off of 5 EL.U/mL\] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.
Swelling (at the SB213503 \& Infanrix injection sites) was categorized as an increase of \> or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling \> or ≤ 50 % of upper arm length, or diameter of injection site missing.
| Arm | Type | Description |
|---|---|---|
| SB213503 lot 1 + M-M-R Group | EXPERIMENTAL | Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. |
| SB213503 lot 2 + M-M-R Group | EXPERIMENTAL | Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. |
| SB213503 lot 3 + M-M-R Group | EXPERIMENTAL | Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. |
| Infanrix + IPOL + M-M-R Group | ACTIVE_COMPARATOR | Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid. |
| Name | Type | Description |
|---|---|---|
| SB213503 lot 1 | BIOLOGICAL | SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0. |
| SB213503 lot 2 | BIOLOGICAL | SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0. |
| SB213503 lot 3 | BIOLOGICAL | SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0. |
| Infanrix | BIOLOGICAL | Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0. |
| IPOL | BIOLOGICAL | IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0. |
| M-M-R II | BIOLOGICAL | M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0. |
Inclusion criteria: * Male or female child between and including 4 and 6 years of age at the time of vaccination. * Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study. * Received 4 doses of Infanrix and 3 doses of IPOL durin...
SB213503 lot 1 is a monoclonal antibody being developed for tetanus, an infectious disease. It is currently in Phase 3 clinical development as an investigational product. The drug is being studied for its immune response and safety in preventing tetanus, along with other components.
SB213503 lot 1 is developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immune response of this investigational monoclonal antibody for tetanus.
SB213503 lot 1 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for its use in tetanus prevention.
SB213503 lot 1 has one completed Phase 3 clinical trial, identified as NCT00148941. This trial, titled 'Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines,' enrolled 4,209 participants in the United States. The study evaluated the drug's immune response and safety in healthy volunteers aged 4 years and older.
SB213503 lot 1 is a monoclonal antibody, not a vaccine. It is being studied in a clinical trial that compares its immune response and safety to existing vaccines for tetanus, diphtheria, and acellular pertussis. The trial is active-controlled, meaning it compares the investigational drug to an active treatment.