Table 4.
Comparison of Current Study Data to Previously Published, Randomized, Clinical Trials of Russian-Backbone Live, Attenuated Influenza Vaccine in Bangladesh and Senegal
| Efficacy Evaluation | Shedding Evaluation | ||||||
|---|---|---|---|---|---|---|---|
| Trial | LAIV Cases | Placebo Cases | Vaccine Efficacy (95% CI) | LAIV Group Vaccine VirusDay 2 | LAIV Group Vaccine VirusDay 4 | LAIV Group Vaccine VirusDay 7 | LAIV Group Vaccine Virus Any Day |
| Bangladesha 2012–2013 | |||||||
| Any vaccine strain | ... | ... | ... | 108/150 (72.0%) | 97/150 (64.7%) | 72/150 (48.0%) | 117/150 (78.0%) |
| Vaccine A/H1N1 | ... | ... | ... | 0/150 (0.0%) | 0/150 (0.0%) | 0/150 (0.0%) | 0/150 (0.0%) |
| Vaccine A/H3N2 | ... | ... | ... | 60/150 (40.0%) | 50/150 (33.3%) | 23/150 (15.3%) | 68/150 (45.3%) |
| Vaccine B | ... | ... | ... | 89/150 (59.3%) | 73/150 (48.7%) | 59/150 (39.3%) | 101/150 (67.3%) |
| Bangladeshb,c 2013–2014 [12] | |||||||
| All strains | 170 (15%) | 144 (25%) | 41.0% (28.0–51.6) | ... | ... | ... | ... |
| All vaccine strains | 79 (7%) | 93 (16%) | 57.5% (43.6–68.0) | ... | ... | ... | ... |
| Vaccine A/H1N1 | 21 (2%) | 21 (4%) | 50.0% (9.2–72.5) | ... | ... | ... | ... |
| Vaccine A/H3N2 | 57 (5%) | 72 (12%) | 60.4% (44.8–71.6) | ... | ... | ... | ... |
| Vaccine B | 2 (0%) | 1 (0%) | 0.0% (−1001.0 to 90.0) | ... | ... | ... | ... |
| Mismatched B | 58 (5%) | 31 (5%) | 6.5% (−43.0 to 38.8) | ... | ... | ... | ... |
| Senegalb,c 2013–2014 [13] | |||||||
| All strains | 210 (18%) | 105 (18%) | 0.0% (−26.4 to 20.9) | ... | ... | ... | ... |
| All vaccine strains | 100 (9%) | 47 (8%) | −6.1 (−50.0 to 25.0) | 48/65 (74%) | 39/66 (59%) | ... | 55/66 (83%) |
| Vaccine A/H1N1 | 79 (7%) | 36 (6%) | –9.7% (−62.6 to 26.1) | 12/65 (19%) | 3/66 (5%) | ... | 14/65 (22%) |
| Vaccine A/H3N2 | 3 (<1%) | 0 (0%) | ... | 31/65 (48%) | 18/66 (27%) | ... | 34/65 (52%) |
| Vaccine B | 20 (2%) | 11 (2%) | 9.5% (−88.9 to 56.6) | 34/65 (52%) | 28/65 (43% | ... | 42/64 (66%) |
| Mismatched B | 115 (10%) | 62 (11%) | 7.3% (−26.3 to 31.9) | ... | ... | ... | ... |
Significant figures are different because of differences in published results among cited studies. Studies included are all the published randomized clinical trials of Russian-backbone LAIV with laboratory-confirmed endpoints.
Abbreviations: CI, confidence interval; LAIV, live, attenuated influenza vaccine.
aThe vaccine used was the World Health Organization–recommended formulation for the Northern Hemisphere 2012–2013 season (A/California/7/2009 [H1N1] pdm09-like virus; A/Victoria/361/2011 [H3N2]-like virus; and B/Wisconsin/1/2010-like virus).
bThe vaccine used was the World Health Organization–recommended formulation for the Northern Hemisphere 2013–2014 season (A/California/7/2009 [H1N1] pdm09-like virus; A/Victoria/361/2011 [H3N2]; and a B/Massachusetts/2/2012-like virus.)
c
Efficacy results are from the per protocol populations.