Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00148941 | Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines | PHASE3 | COMPLETED | 4,209 | — | — | Jan 6, 2005 | Dec 4, 2006 | Feb 5, 2020 | 24 | United States |
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...