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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01439360 | An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children | PHASE3 | COMPLETED | 12,046 | — | — | Oct 1, 2011 | Dec 31, 2014 | Sep 26, 2018 | 103 | Bangladesh, Belgium +11 |
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
| Arm | Type | Description |
|---|---|---|
| D-QIV | EXPERIMENTAL | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). |
| Control | ACTIVE_COMPARATOR | In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). |
| Name | Type | Description |
|---|---|---|
| Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A | BIOLOGICAL | Intramuscular injection |
| Havrix Junior | BIOLOGICAL | Intramuscular injection administered to subjects aged 12 months or older |
| Prevenar 13 | BIOLOGICAL | Intramuscular injection administered to subjects less than 12 months of age |
| Varivax/ProVarivax | BIOLOGICAL | Intramuscular injection administered to subjects more than 12 months of age |
| Varilrix | BIOLOGICAL | Subcutaneous injection administered to subjects more than 12 months of age |
Inclusion Criteria: * Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligib...