Immunogenicity of QIV and TIV-Yam and TIV-Vic in Children 3–17 Years of Age and of QIV in Children 6 to 35 Months of Age: ATP Immunogenicity Cohort
| . | . | . | GMT . | SCRa . | SPRa . | SCF . |
|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Value (95% CI) . | % (95% CI) . | % (95% CI) . | Value (95% CI) . |
| A/California/7/2009 (H1N1) | ||||||
| QIV | Pre | 876 | 29.4 (26.8, 32.2) | … | 54.8 (51.4, 58.1) | … |
| Post | 878 | 362.7 (335.3, 392.3) | 84.4 (81.8, 86.7) | 96.8 (95.4, 97.9) | 12.3 (11.3, 13.4) | |
| TIV-Vic | Pre | 870 | 32.2 (29.4, 35.3) | … | 57.0 (53.6, 60.3) | … |
| Post | 871 | 429.1 (396.5, 464.3) | 86.8 (84.3, 89.0) | 97.4 (96.1, 98.3) | 13.3 (12.3, 14.4) | |
| TIV-Yam | Pre | 877 | 29.1 (26.6, 31.8) | … | 54.4 (51.0, 57.7) | … |
| Post | 878 | 420.2 (388.8, 454.0) | 85.5 (83.0, 87.8) | 96.6 (95.2, 97.7) | 14.4 (13.3, 15.7) | |
| QIV-only (6–35 mo) | Pre | 259 | 16.8 (13.9, 20.3) | … | 33.6 (27.9, 39.7) | … |
| Post | 259 | 200.9 (166.6, 242.2) | 84.9 (80.0, 89.1) | 89.6 (85.2, 93.0) | 12.0 (10.5, 13.6) | |
| A/Victoria/210/2009 (H3N2) | ||||||
| QIV | Pre | 876 | 18.1 (16.7, 19.7) | … | 33.7 (30.5, 36.9) | … |
| Post | 878 | 143.7 (134.2, 153.9) | 70.1 (66.9, 73.1) | 92.9 (91.0, 94.5) | 7.9 (7.3, 8.6) | |
| TIV-Vic | Pre | 870 | 19.0 (17.4, 20.6) | … | 34.6 (31.4, 37.9) | … |
| Post | 871 | 139.6 (130.5, 149.3) | 67.8 (64.6, 70.9) | 92.8 (90.8, 94.4) | 7.4 (6.8, 8.0) | |
| TIV-Yam | Pre | 876 | 19.4 (17.8, 21.1) | … | 37.0 (33.8, 40.3) | … |
| Post | 878 | 151.0 (141.0, 161.6) | 69.6 (66.5, 72.7) | 93.3 (91.4, 94.8) | 7.8 (7.2, 8.5) | |
| QIV-only | Pre | 259 | 5.6 (5.3, 6.0) | … | 2.70 (1.1, 5.5) | … |
| Post | 259 | 61.4 (53.8, 70.0) | 73.0 (67.1, 78.3) | 74.5 (68.8, 79.7) | 10.9 (9.6, 12.4) | |
| B/Brisbane/60/2008 (Victoria) | ||||||
| QIV | Pre | 876 | 24.8 (22.5, 27.3) | … | 44.3 (41.0, 47.7) | … |
| Post | 878 | 250.5 (230.8, 272.0) | 74.5 (71.5, 77.4) | 95.4 (93.8, 96.7) | 10.1 (9.2, 11.1) | |
| TIV-Vic | Pre | 870 | 25.8 (23.5, 28.4) | … | 46.4 (43.1, 49.8) | … |
| Post | 871 | 245.4 (226.9, 265.4) | 71.5 (68.4, 74.5) | 96.3 (94.9, 97.5) | 9.5 (8.6, 10.5) | |
| TIV-Yam | Pre | 877 | 25.8 (23.5, 28.4) | … | 45.6 (42.3, 49.0) | … |
| Post | 877 | 68.1 (61.9, 74.9) | 29.9 (26.9, 33.1) | 73.3 (70.3, 76.2) | 2.6 (2.5, 2.8) | |
| QIV-only | Pre | 259 | 8.7 (7.5, 10.0) | … | 10.8 (7.3, 15.2) | … |
| Post | 259 | 127.3 (109.4, 148.1) | 84.6 (79.6, 88.7) | 88.0 (83.4, 91.7) | 14.6 (12.8, 16.6) | |
| B/Florida/4/2006 (Yamagata) | ||||||
| QIV | Pre | 876 | 57.9 (52.0, 64.4) | … | 66.0 (62.7, 69.1) | … |
| Post | 878 | 512.5 (477.6, 549.9) | 75.2 (72.2, 78.1) | 99.0 (8.1, 99.5) | 8.9 (8.1, 9.7) | |
| TIV-Vic | Pre | 870 | 58.4 (52.6, 64.9) | … | 67.0 (63.8, 70.1) | … |
| Post | 871 | 197.0 (180.7, 214.8) | 41.3 (38.0, 44.6) | 92.4 (90.5, 94.1) | 3.4 (3.1, 3.6) | |
| TIV-Yam | Pre | 877 | 65.9 (59.3, 73.2) | … | 70.9 (67.8, 73.9) | … |
| Post | 878 | 579.0 (541.2, 619.3) | 73.4 (70.4, 76.3) | 99.4 (98.7, 99.8) | 8.8 (8.1, 9.6) | |
| QIV-only | Pre | 259 | 7.7 (7.0, 8.6) | … | 8.5 (5.4, 12.6) | … |
| Post | 259 | 192.7 (172.1, 215.7) | 93.8 (90.2, 96.4) | 96.5 (93.5, 98.4) | 24.9 (22.0, 28.3) | |
| . | . | . | GMT . | SCRa . | SPRa . | SCF . |
|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Value (95% CI) . | % (95% CI) . | % (95% CI) . | Value (95% CI) . |
| A/California/7/2009 (H1N1) | ||||||
| QIV | Pre | 876 | 29.4 (26.8, 32.2) | … | 54.8 (51.4, 58.1) | … |
| Post | 878 | 362.7 (335.3, 392.3) | 84.4 (81.8, 86.7) | 96.8 (95.4, 97.9) | 12.3 (11.3, 13.4) | |
| TIV-Vic | Pre | 870 | 32.2 (29.4, 35.3) | … | 57.0 (53.6, 60.3) | … |
| Post | 871 | 429.1 (396.5, 464.3) | 86.8 (84.3, 89.0) | 97.4 (96.1, 98.3) | 13.3 (12.3, 14.4) | |
| TIV-Yam | Pre | 877 | 29.1 (26.6, 31.8) | … | 54.4 (51.0, 57.7) | … |
| Post | 878 | 420.2 (388.8, 454.0) | 85.5 (83.0, 87.8) | 96.6 (95.2, 97.7) | 14.4 (13.3, 15.7) | |
| QIV-only (6–35 mo) | Pre | 259 | 16.8 (13.9, 20.3) | … | 33.6 (27.9, 39.7) | … |
| Post | 259 | 200.9 (166.6, 242.2) | 84.9 (80.0, 89.1) | 89.6 (85.2, 93.0) | 12.0 (10.5, 13.6) | |
| A/Victoria/210/2009 (H3N2) | ||||||
| QIV | Pre | 876 | 18.1 (16.7, 19.7) | … | 33.7 (30.5, 36.9) | … |
| Post | 878 | 143.7 (134.2, 153.9) | 70.1 (66.9, 73.1) | 92.9 (91.0, 94.5) | 7.9 (7.3, 8.6) | |
| TIV-Vic | Pre | 870 | 19.0 (17.4, 20.6) | … | 34.6 (31.4, 37.9) | … |
| Post | 871 | 139.6 (130.5, 149.3) | 67.8 (64.6, 70.9) | 92.8 (90.8, 94.4) | 7.4 (6.8, 8.0) | |
| TIV-Yam | Pre | 876 | 19.4 (17.8, 21.1) | … | 37.0 (33.8, 40.3) | … |
| Post | 878 | 151.0 (141.0, 161.6) | 69.6 (66.5, 72.7) | 93.3 (91.4, 94.8) | 7.8 (7.2, 8.5) | |
| QIV-only | Pre | 259 | 5.6 (5.3, 6.0) | … | 2.70 (1.1, 5.5) | … |
| Post | 259 | 61.4 (53.8, 70.0) | 73.0 (67.1, 78.3) | 74.5 (68.8, 79.7) | 10.9 (9.6, 12.4) | |
| B/Brisbane/60/2008 (Victoria) | ||||||
| QIV | Pre | 876 | 24.8 (22.5, 27.3) | … | 44.3 (41.0, 47.7) | … |
| Post | 878 | 250.5 (230.8, 272.0) | 74.5 (71.5, 77.4) | 95.4 (93.8, 96.7) | 10.1 (9.2, 11.1) | |
| TIV-Vic | Pre | 870 | 25.8 (23.5, 28.4) | … | 46.4 (43.1, 49.8) | … |
| Post | 871 | 245.4 (226.9, 265.4) | 71.5 (68.4, 74.5) | 96.3 (94.9, 97.5) | 9.5 (8.6, 10.5) | |
| TIV-Yam | Pre | 877 | 25.8 (23.5, 28.4) | … | 45.6 (42.3, 49.0) | … |
| Post | 877 | 68.1 (61.9, 74.9) | 29.9 (26.9, 33.1) | 73.3 (70.3, 76.2) | 2.6 (2.5, 2.8) | |
| QIV-only | Pre | 259 | 8.7 (7.5, 10.0) | … | 10.8 (7.3, 15.2) | … |
| Post | 259 | 127.3 (109.4, 148.1) | 84.6 (79.6, 88.7) | 88.0 (83.4, 91.7) | 14.6 (12.8, 16.6) | |
| B/Florida/4/2006 (Yamagata) | ||||||
| QIV | Pre | 876 | 57.9 (52.0, 64.4) | … | 66.0 (62.7, 69.1) | … |
| Post | 878 | 512.5 (477.6, 549.9) | 75.2 (72.2, 78.1) | 99.0 (8.1, 99.5) | 8.9 (8.1, 9.7) | |
| TIV-Vic | Pre | 870 | 58.4 (52.6, 64.9) | … | 67.0 (63.8, 70.1) | … |
| Post | 871 | 197.0 (180.7, 214.8) | 41.3 (38.0, 44.6) | 92.4 (90.5, 94.1) | 3.4 (3.1, 3.6) | |
| TIV-Yam | Pre | 877 | 65.9 (59.3, 73.2) | … | 70.9 (67.8, 73.9) | … |
| Post | 878 | 579.0 (541.2, 619.3) | 73.4 (70.4, 76.3) | 99.4 (98.7, 99.8) | 8.8 (8.1, 9.6) | |
| QIV-only | Pre | 259 | 7.7 (7.0, 8.6) | … | 8.5 (5.4, 12.6) | … |
| Post | 259 | 192.7 (172.1, 215.7) | 93.8 (90.2, 96.4) | 96.5 (93.5, 98.4) | 24.9 (22.0, 28.3) | |
Abbreviations: ATP, according to protocol; CI, confidence interval; GMT, geometric mean titer; Post, postvaccination; Pre, prevaccination; QIV, quadrivalent influenza vaccine; SCF, seroconversion factor (defined as the geometric mean of the within-subjects ratios of the postvaccination reciprocal HI titer to the day 0 reciprocal HI titer); SCR, seroconversion rate (defined as the proportion of vaccinees with either a prevaccination titer <1:10 and a postvaccination titer ≥1:40, or a prevaccination titer ≥1:10 and at least a 4-fold increase in postvaccination titer); SPR, seroprotection rate (defined as the percentage of subjects who had a serum anti-HI antibody titer ≥1:40); TIV-Vic, trivalent influenza vaccine Victoria lineage B strain; TIV-Yam, trivalent influenza vaccine Yamagata lineage B strain.
a Each of the 4 strains contained in the QIV met Center for Biologics Evaluation and Research licensure criteria for immunogenicity (lower limit of 95% CI for SCR of at least 40% and a postvaccination SPR of at least 70%).
Immunogenicity of QIV and TIV-Yam and TIV-Vic in Children 3–17 Years of Age and of QIV in Children 6 to 35 Months of Age: ATP Immunogenicity Cohort
| . | . | . | GMT . | SCRa . | SPRa . | SCF . |
|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Value (95% CI) . | % (95% CI) . | % (95% CI) . | Value (95% CI) . |
| A/California/7/2009 (H1N1) | ||||||
| QIV | Pre | 876 | 29.4 (26.8, 32.2) | … | 54.8 (51.4, 58.1) | … |
| Post | 878 | 362.7 (335.3, 392.3) | 84.4 (81.8, 86.7) | 96.8 (95.4, 97.9) | 12.3 (11.3, 13.4) | |
| TIV-Vic | Pre | 870 | 32.2 (29.4, 35.3) | … | 57.0 (53.6, 60.3) | … |
| Post | 871 | 429.1 (396.5, 464.3) | 86.8 (84.3, 89.0) | 97.4 (96.1, 98.3) | 13.3 (12.3, 14.4) | |
| TIV-Yam | Pre | 877 | 29.1 (26.6, 31.8) | … | 54.4 (51.0, 57.7) | … |
| Post | 878 | 420.2 (388.8, 454.0) | 85.5 (83.0, 87.8) | 96.6 (95.2, 97.7) | 14.4 (13.3, 15.7) | |
| QIV-only (6–35 mo) | Pre | 259 | 16.8 (13.9, 20.3) | … | 33.6 (27.9, 39.7) | … |
| Post | 259 | 200.9 (166.6, 242.2) | 84.9 (80.0, 89.1) | 89.6 (85.2, 93.0) | 12.0 (10.5, 13.6) | |
| A/Victoria/210/2009 (H3N2) | ||||||
| QIV | Pre | 876 | 18.1 (16.7, 19.7) | … | 33.7 (30.5, 36.9) | … |
| Post | 878 | 143.7 (134.2, 153.9) | 70.1 (66.9, 73.1) | 92.9 (91.0, 94.5) | 7.9 (7.3, 8.6) | |
| TIV-Vic | Pre | 870 | 19.0 (17.4, 20.6) | … | 34.6 (31.4, 37.9) | … |
| Post | 871 | 139.6 (130.5, 149.3) | 67.8 (64.6, 70.9) | 92.8 (90.8, 94.4) | 7.4 (6.8, 8.0) | |
| TIV-Yam | Pre | 876 | 19.4 (17.8, 21.1) | … | 37.0 (33.8, 40.3) | … |
| Post | 878 | 151.0 (141.0, 161.6) | 69.6 (66.5, 72.7) | 93.3 (91.4, 94.8) | 7.8 (7.2, 8.5) | |
| QIV-only | Pre | 259 | 5.6 (5.3, 6.0) | … | 2.70 (1.1, 5.5) | … |
| Post | 259 | 61.4 (53.8, 70.0) | 73.0 (67.1, 78.3) | 74.5 (68.8, 79.7) | 10.9 (9.6, 12.4) | |
| B/Brisbane/60/2008 (Victoria) | ||||||
| QIV | Pre | 876 | 24.8 (22.5, 27.3) | … | 44.3 (41.0, 47.7) | … |
| Post | 878 | 250.5 (230.8, 272.0) | 74.5 (71.5, 77.4) | 95.4 (93.8, 96.7) | 10.1 (9.2, 11.1) | |
| TIV-Vic | Pre | 870 | 25.8 (23.5, 28.4) | … | 46.4 (43.1, 49.8) | … |
| Post | 871 | 245.4 (226.9, 265.4) | 71.5 (68.4, 74.5) | 96.3 (94.9, 97.5) | 9.5 (8.6, 10.5) | |
| TIV-Yam | Pre | 877 | 25.8 (23.5, 28.4) | … | 45.6 (42.3, 49.0) | … |
| Post | 877 | 68.1 (61.9, 74.9) | 29.9 (26.9, 33.1) | 73.3 (70.3, 76.2) | 2.6 (2.5, 2.8) | |
| QIV-only | Pre | 259 | 8.7 (7.5, 10.0) | … | 10.8 (7.3, 15.2) | … |
| Post | 259 | 127.3 (109.4, 148.1) | 84.6 (79.6, 88.7) | 88.0 (83.4, 91.7) | 14.6 (12.8, 16.6) | |
| B/Florida/4/2006 (Yamagata) | ||||||
| QIV | Pre | 876 | 57.9 (52.0, 64.4) | … | 66.0 (62.7, 69.1) | … |
| Post | 878 | 512.5 (477.6, 549.9) | 75.2 (72.2, 78.1) | 99.0 (8.1, 99.5) | 8.9 (8.1, 9.7) | |
| TIV-Vic | Pre | 870 | 58.4 (52.6, 64.9) | … | 67.0 (63.8, 70.1) | … |
| Post | 871 | 197.0 (180.7, 214.8) | 41.3 (38.0, 44.6) | 92.4 (90.5, 94.1) | 3.4 (3.1, 3.6) | |
| TIV-Yam | Pre | 877 | 65.9 (59.3, 73.2) | … | 70.9 (67.8, 73.9) | … |
| Post | 878 | 579.0 (541.2, 619.3) | 73.4 (70.4, 76.3) | 99.4 (98.7, 99.8) | 8.8 (8.1, 9.6) | |
| QIV-only | Pre | 259 | 7.7 (7.0, 8.6) | … | 8.5 (5.4, 12.6) | … |
| Post | 259 | 192.7 (172.1, 215.7) | 93.8 (90.2, 96.4) | 96.5 (93.5, 98.4) | 24.9 (22.0, 28.3) | |
| . | . | . | GMT . | SCRa . | SPRa . | SCF . |
|---|---|---|---|---|---|---|
| Group . | Timing . | N . | Value (95% CI) . | % (95% CI) . | % (95% CI) . | Value (95% CI) . |
| A/California/7/2009 (H1N1) | ||||||
| QIV | Pre | 876 | 29.4 (26.8, 32.2) | … | 54.8 (51.4, 58.1) | … |
| Post | 878 | 362.7 (335.3, 392.3) | 84.4 (81.8, 86.7) | 96.8 (95.4, 97.9) | 12.3 (11.3, 13.4) | |
| TIV-Vic | Pre | 870 | 32.2 (29.4, 35.3) | … | 57.0 (53.6, 60.3) | … |
| Post | 871 | 429.1 (396.5, 464.3) | 86.8 (84.3, 89.0) | 97.4 (96.1, 98.3) | 13.3 (12.3, 14.4) | |
| TIV-Yam | Pre | 877 | 29.1 (26.6, 31.8) | … | 54.4 (51.0, 57.7) | … |
| Post | 878 | 420.2 (388.8, 454.0) | 85.5 (83.0, 87.8) | 96.6 (95.2, 97.7) | 14.4 (13.3, 15.7) | |
| QIV-only (6–35 mo) | Pre | 259 | 16.8 (13.9, 20.3) | … | 33.6 (27.9, 39.7) | … |
| Post | 259 | 200.9 (166.6, 242.2) | 84.9 (80.0, 89.1) | 89.6 (85.2, 93.0) | 12.0 (10.5, 13.6) | |
| A/Victoria/210/2009 (H3N2) | ||||||
| QIV | Pre | 876 | 18.1 (16.7, 19.7) | … | 33.7 (30.5, 36.9) | … |
| Post | 878 | 143.7 (134.2, 153.9) | 70.1 (66.9, 73.1) | 92.9 (91.0, 94.5) | 7.9 (7.3, 8.6) | |
| TIV-Vic | Pre | 870 | 19.0 (17.4, 20.6) | … | 34.6 (31.4, 37.9) | … |
| Post | 871 | 139.6 (130.5, 149.3) | 67.8 (64.6, 70.9) | 92.8 (90.8, 94.4) | 7.4 (6.8, 8.0) | |
| TIV-Yam | Pre | 876 | 19.4 (17.8, 21.1) | … | 37.0 (33.8, 40.3) | … |
| Post | 878 | 151.0 (141.0, 161.6) | 69.6 (66.5, 72.7) | 93.3 (91.4, 94.8) | 7.8 (7.2, 8.5) | |
| QIV-only | Pre | 259 | 5.6 (5.3, 6.0) | … | 2.70 (1.1, 5.5) | … |
| Post | 259 | 61.4 (53.8, 70.0) | 73.0 (67.1, 78.3) | 74.5 (68.8, 79.7) | 10.9 (9.6, 12.4) | |
| B/Brisbane/60/2008 (Victoria) | ||||||
| QIV | Pre | 876 | 24.8 (22.5, 27.3) | … | 44.3 (41.0, 47.7) | … |
| Post | 878 | 250.5 (230.8, 272.0) | 74.5 (71.5, 77.4) | 95.4 (93.8, 96.7) | 10.1 (9.2, 11.1) | |
| TIV-Vic | Pre | 870 | 25.8 (23.5, 28.4) | … | 46.4 (43.1, 49.8) | … |
| Post | 871 | 245.4 (226.9, 265.4) | 71.5 (68.4, 74.5) | 96.3 (94.9, 97.5) | 9.5 (8.6, 10.5) | |
| TIV-Yam | Pre | 877 | 25.8 (23.5, 28.4) | … | 45.6 (42.3, 49.0) | … |
| Post | 877 | 68.1 (61.9, 74.9) | 29.9 (26.9, 33.1) | 73.3 (70.3, 76.2) | 2.6 (2.5, 2.8) | |
| QIV-only | Pre | 259 | 8.7 (7.5, 10.0) | … | 10.8 (7.3, 15.2) | … |
| Post | 259 | 127.3 (109.4, 148.1) | 84.6 (79.6, 88.7) | 88.0 (83.4, 91.7) | 14.6 (12.8, 16.6) | |
| B/Florida/4/2006 (Yamagata) | ||||||
| QIV | Pre | 876 | 57.9 (52.0, 64.4) | … | 66.0 (62.7, 69.1) | … |
| Post | 878 | 512.5 (477.6, 549.9) | 75.2 (72.2, 78.1) | 99.0 (8.1, 99.5) | 8.9 (8.1, 9.7) | |
| TIV-Vic | Pre | 870 | 58.4 (52.6, 64.9) | … | 67.0 (63.8, 70.1) | … |
| Post | 871 | 197.0 (180.7, 214.8) | 41.3 (38.0, 44.6) | 92.4 (90.5, 94.1) | 3.4 (3.1, 3.6) | |
| TIV-Yam | Pre | 877 | 65.9 (59.3, 73.2) | … | 70.9 (67.8, 73.9) | … |
| Post | 878 | 579.0 (541.2, 619.3) | 73.4 (70.4, 76.3) | 99.4 (98.7, 99.8) | 8.8 (8.1, 9.6) | |
| QIV-only | Pre | 259 | 7.7 (7.0, 8.6) | … | 8.5 (5.4, 12.6) | … |
| Post | 259 | 192.7 (172.1, 215.7) | 93.8 (90.2, 96.4) | 96.5 (93.5, 98.4) | 24.9 (22.0, 28.3) | |
Abbreviations: ATP, according to protocol; CI, confidence interval; GMT, geometric mean titer; Post, postvaccination; Pre, prevaccination; QIV, quadrivalent influenza vaccine; SCF, seroconversion factor (defined as the geometric mean of the within-subjects ratios of the postvaccination reciprocal HI titer to the day 0 reciprocal HI titer); SCR, seroconversion rate (defined as the proportion of vaccinees with either a prevaccination titer <1:10 and a postvaccination titer ≥1:40, or a prevaccination titer ≥1:10 and at least a 4-fold increase in postvaccination titer); SPR, seroprotection rate (defined as the percentage of subjects who had a serum anti-HI antibody titer ≥1:40); TIV-Vic, trivalent influenza vaccine Victoria lineage B strain; TIV-Yam, trivalent influenza vaccine Yamagata lineage B strain.
a Each of the 4 strains contained in the QIV met Center for Biologics Evaluation and Research licensure criteria for immunogenicity (lower limit of 95% CI for SCR of at least 40% and a postvaccination SPR of at least 70%).
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