Evaluation of 13-valent pneumococcal conjugate vaccine and concomitant meningococcal group C conjugate vaccine in healthy infants and toddlers in Spain

Comparison of lyophilized versus liquid modified vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naïve subjects

“…Assuming a standard deviation of 2.8 for log 2 peak PRNT or ELISA titer in each group (default for BN's PRNT 50 assay at time of protocol development), a non-inferiority margin of 2.0-fold [32][33][34], a type I error rate of 1.25%, and drop-out rate of 10%, 165 subjects in each of the three groups were to be enrolled in this study to achieve at least 148 evaluable subjects. To maintain at least 148 evaluable subjects per arm, an additional 29/151 (15.1%) subjects were enrolled to replace subjects who did not receive their second vaccination.…”

Associations between geographic region and immune response variations to pneumococcal conjugate vaccines in clinical trials: A systematic review and meta-analysis

“…Study arms from Japan were excluded because the PCVs were given subcutaneously Togashi et al, 2015;Togashi et al, 2013). Of the 33 study arms evaluating PCV immunogenicity in the different regions, the studies conducted in the WPR (Huang et al, 2012;Kim et al, 2011;Kim et al, 2013;Kim et al, 2007;Shao et al, 2004) showed higher GMCs compared to studies conducted in Europe (Diez-Domingo et al, 2013;Givon-Lavi et al, 2010;Kieninger et al, 2010;Martinon-Torres et al, 2012;Wysocki et al, 2009) and the Americas (Bryant et al, 2010;Gutierrez Brito et al, 2013;Lagos et al, 2014;Payton et al, 2013;Pichichero et al, 2007;Ruiz-Palacios et al, 2011;Scheifele et al, 2006;Tapiero et al, 2013;Yeh et al, 2010). The pooled GMC for serotype 4 after three doses of PCV7 (Figure 4) in the WPR was 5.19 mg/ml (95% CI 4.85-5.53 mg/ ml), while for studies conducted in Europe this was 2.01 mg/ml (95% CI 1.88-2.14 mg/ml).…”

“…Table 1 reports details of the study arms included in the systematic review: nine were studied in Africa (Dicko et al, 2011;Idoko et al, 2017;Jones et al, 2013;Madhi et al, 2017a;Madhi et al, 2017b;Moisi et al, 2018), 26 in the Americas (Black et al, 2000;Bryant et al, 2010;Gutierrez Brito et al, 2013;Lagos et al, 2014;Payton et al, 2013;Pichichero et al, 2007;Rennels et al, 1998;Ruiz-Palacios et al, 2011;Scheifele et al, 2006;Shinefield et al, 1999;Tapiero et al, 2013;Yeh et al, 2010), 56 in Europe (Bermal et al, 2009;Diez-Domingo et al, 2013;Esposito et al, 2005;Esposito et al, 2010;Gadzinowski et al, 2011;Givon-Lavi et al, 2010;Goldblatt et al, 2018;Grimprel et al, 2011;Iro et al, 2015;Kayhty et al, 2005;Kieninger et al, 2010;Knuf et al, 2006;Martinon-Torres et al, 2015;Martinon-Torres et al, 2012;Moss et al, 2010;Olivier et al, 2008;Reinert et al, 2008;Rodgers et 2013; Schmitt et al, 2003;Silfverdal et al, 2009;Snape e...…”

“…The pooled estimate of antibody responses was higher in the WPR, SEA, and Africa regions when compared to the Americas and Europe. The forest plots of the pneumococcal IgG GMCs on serotype 4 for (A) PCV7 (Bryant et al, 2010;Givon-Lavi et al, 2010;Huang et al, 2012;Kieninger et al, 2010;Kim et al, 2011;Kim et al, 2013;Kim et al, 2007;Pichichero et al, 2007;Scheifele et al, 2006;Shao et al, 2004;Tapiero et al, 2013;Wysocki et al, 2009;Yeh et al, 2010), (B) PCV10 (Kim et al, 2011;Lagos et al, 2014;Ruiz-Palacios et al, 2011;Wysocki et al, 2009), and (C) PCV13 (Bryant et al, 2010;Diez-Domingo et al, 2013;Gutierrez Brito et al, 2013;Huang et al, 2012;Kieninger et al, 2010;Kim et al, 2013;Martinon-Torres et al, 2012;Payton et al, 2013;Yeh et al, 2010) are shown in Figure 4. Studies with the 2, 4, 6-month schedule with co-administered DTaP vaccine were included.…”

Comparison of three sample size calculation methods for non-inferiority vaccine trials with multiple continuous co-primary endpoints

“…The lower limit of the confidence interval for the difference between μ T and μ C should be greater than -d, which is the same as requiring the lower limit of the confidence interval for the ratio of the geometric means e μ T and e μ C greater than λ, where d = ln(1/λ). A commonly used margin [19][20][21][22] for the ratio is ln(1/2), which means that the experimental vaccine be at least half as efficacious as the control vaccine.…”