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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02096263 | Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants | PHASE3 | COMPLETED | 585 | — | — | Apr 16, 2014 | Nov 13, 2015 | Nov 27, 2019 | 43 | United States |
| NCT01353703 | Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine | PHASE3 | COMPLETED | 224 | — | — | Apr 16, 2012 | Feb 25, 2013 | Jan 2, 2020 | 4 | India |
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
| Arm | Type | Description |
|---|---|---|
| Infanrix hexa Group | EXPERIMENTAL | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pediarix Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| Pentacel Group | ACTIVE_COMPARATOR | Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh. |
| INFANRIX HEXA 6-10-14 GROUP | EXPERIMENTAL | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. |
| INFANRIX HEXA 2-4-6 GROUP | ACTIVE_COMPARATOR | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
| Name | Type | Description |
|---|---|---|
| Infanrix hexa | BIOLOGICAL | 3 doses administered intramuscularly in the right thigh. |
| Pediarix | BIOLOGICAL | 3 doses administered intramuscularly in the right thigh |
| ActHIB | BIOLOGICAL | 4 doses administered intramuscularly in the upper left thigh |
| Pentacel | BIOLOGICAL | 4 doses administered intramuscularly in the right thigh |
| Engerix-B | BIOLOGICAL | 2 or 3 doses administered intramuscularly in the upper left thigh |
| Infanrix | BIOLOGICAL | 1 dose administered intramuscularly in the right thigh |
| Hiberix | BIOLOGICAL | 1 dose administered intramuscularly in the left thigh |
| Prevnar13 | BIOLOGICAL | 3 doses administered intramuscularly in the lower left thigh |
| Rotarix | BIOLOGICAL | 2 doses administered orally |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, three doses |
Inclusion Criteria: * Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) 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. * Born f...