Table 1.
Virus type and PDK passage | Child study | Infant study | ||||
---|---|---|---|---|---|---|
Primary F17/Pre | Booster dose F17/Pre | Primary F17/Pre | Booster dose F17 | |||
log10 FFU/mL | log10 FFU/mL | |||||
Dose 1 | Dose 2* | log10 FFU/mL | Dose 1 | Dose 2† | log10 FFU/mL (at release) | |
DENV-1 (45AZ5) PDK 27 | 6.1 | 6.2 | 6.0 | 6.1 (1/10 dil 5.0) | 6.2 (1/10 dil 4.9) | 4.9 |
DENV-2 (S16803) PDK 50 | 6.2 | 6.4 | 6.1 | 6.3 (1/10 dil 5.3) | 6.3 (1/10 dil 5.3) | 5.3 |
DENV-3 (CH53489) PDK 20 | 5.1 | 5.0 | 5.0 | 4.8 (1/10 dil 4.1) | 4.7 (1/10 dil 3.9) | 4.7 |
DENV-4 (341750) PDK 6 | 6.3 | 6.1 | 6.1 | 6.0 (1/10 dil 5.0) | 6.0 (1/10 dil 5.3) | 5.0 |
DENV = dengue virus; dil = dilution; FFU = focus forming units; PDK = primary dog kidney.
Inactive ingredients for F17/Pre: 2.5% human serum albumin and 7.5% lactose as stabilizer, Eagle's Minimum Essential Medium (EMEM) cell culture medium, streptomycin, neomycin. Inactive ingredients for F17: cell culture medium EMEM, and stabilizers carbohydrates and amino acids for injection, streptomycin, neomycin and a proprietary stabilizer provided by GSK Vaccines.
Average of two independent F17/Pre retains.
Average of four independent F17/Pre retains (only for the undiluted preparations).