Table 2.
Hemagglutination Inhibition Antibodies to Vaccine-Homologous A/Indonesia/5/2005 and Vaccine-Heterologous A/Vietnam/1194/2004 After Vaccination—Per-Protocol Cohorts for Immunogenicity and Persistence
| Group, Time Pointa | A/Indonesia/5/2005 |
A/Vietnam/1194/2004 |
||||
|---|---|---|---|---|---|---|
| No. | SCR, % (95% CI) | SPR, % (95% CI) | No. | SCR, % (95% CI) | SPR, % (95% CI) | |
| CC-3.75 µgHA + AS03A | ||||||
| Day 0b | 124 | … | 6.5 (2.8–12.3) | 48 | … | 12.5 (4.7–25.2) |
| Day 21 | 124 | 48.4 (39.3–57.5) | 58.1 (48.9–66.9) | 48 | 18.8 (8.9–32.6) | 31.3 (18.7–46.3) |
| Day 42 | 119 | 97.5 (92.8–99.5) | 100 (96.9–100) | 46 | 73.9 (58.9–85.7) | 84.8 (71.1–93.7) |
| Month 6 | 112 | 56.3 (46.6–65.6) | 62.5 (52.9–71.5) | 43 | 14.0 (5.3–27.9) | 27.9 (15.3–43.7) |
| Month 12 | 106 | 29.2 (20.8–38.9) | 32.1 (23.3–41.8) | 40 | 7.5 (1.6–20.4) | 17.5 (7.3–32.8) |
| CC-1.9 µgHA + AS03B | ||||||
| Day 0b | 77 | … | 15.6 (8.3–25.6) | 52 | … | 19.2 (9.6–32.5) |
| Day 21 | 77 | 35.1 (24.5–46.8) | 50.6 (39.0–62.2) | 52 | 13.5 (5.6–25.8) | 36.5 (23.6–51.0) |
| Day 42 | 75 | 89.3 (80.1–95.3) | 97.3 (90.7–99.7) | 50 | 60.0 (45.2–73.6) | 88.0 (75.7–95.5) |
| Month 6 | 73 | 34.2 (23.5–46.3) | 46.6 (34.8–58.6) | 50 | 4.0 (.5–13.7) | 14.0 (5.8–26.7) |
| Month 12 | 71 | 11.3 (5.0–21.0) | 18.3 (10.1–29.3) | 49 | 4.1 (.5–14.0) | 6.1 (1.3–16.9) |
| CC-15 µgPlainHA | ||||||
| Day 0b | 50 | … | 4.0 (0.5–13.7) | 50 | … | 0.0 (.0–7.1) |
| Day 21 | 50 | 4.0 (.5–13.7) | 4.0 (.5–13.7) | 50 | 8.0 (2.2–19.2) | 10.0 (3.3–21.8) |
| Day 42 | 49 | 26.5 (14.9–41.1) | 28.6 (16.6–43.3) | 49 | 12.2 (4.6–24.8) | 16.3 (7.3–29.7) |
| Month 6 | 45 | 2.2 (.1–11.8) | 4.4 (.5–15.1) | 45 | 6.7 (1.4–18.3) | 6.7 (1.4–18.3) |
| Month 12 | 43 | 0.0 (.0–8.2) | 2.3 (.1–12.3) | 43 | 2.3 (.1–12.3) | 4.7 (.6–15.8) |
| Q-3.75 µgHA + AS03A | ||||||
| Day 0b | 80 | … | 17.5 (9.9–27.6) | 53 | … | 24.5 (13.8–38.3) |
| Day 21 | 80 | 46.3 (35.0–57.8) | 63.8 (52.2–74.2) | 53 | 15.1 (6.7–27.6) | 35.8 (23.1–50.2) |
| Day 42 | 78 | 94.9 (87.4–98.6) | 97.4 (91.0–99.7) | 52 | 53.8 (39.5–67.8) | 78.8 (65.3–88.9) |
| Month 6 | 73 | 47.9 (36.1–60.0) | 58.9 (46.8–70.3) | 49 | 8.2 (2.3–19.6) | 12.2 (4.6–24.8) |
| Month 12 | 69 | 24.6 (15.1–36.5) | 31.9 (21.2–44.2) | 46 | 4.3 (.5–14.8) | 6.5 (1.4–17.9) |
| Q-15 µgPlainHA | ||||||
| Day 0b | 49 | … | 2.0 (.1–10.9) | 49 | … | 4.1 (.5–14.0) |
| Day 21 | 49 | 6.1 (1.3–16.9) | 8.2 (2.3–19.6) | 49 | 6.1 (1.3–16.9) | 10.2 (3.4–22.2) |
| Day 42 | 49 | 51.0 (36.3–65.6) | 53.1 (38.3–67.5) | 49 | 8.2 (2.3–19.6) | 12.2 (4.6–24.8) |
| Month 6 | 45 | 6.7 (1.4–18.3) | 8.9 (2.5–21.2) | 45 | 2.2 (.1–11.8) | 11.1 (3.7–24.1) |
| Month 12 | 42 | 0.0 (.0–8.4) | 2.4 (.1–12.6) | 42 | 0.0 (.0–8.4) | 4.8 (.6–16.2) |
| Placebo (saline) | ||||||
| Day 0b | 127 | … | 11.8 (6.8–18.7) | 50 | … | 10.0 (3.3–21.8) |
| Day 21 | 127 | 1.6 (.2–5.6) | 9.4 (5.0–15.9) | 50 | 4.0 (.5–13.7) | 16.0 (7.2–29.1) |
| Day 42 | 120 | 4.2 (1.4–9.5) | 10.0 (5.3–16.8) | 48 | 0.0 (.0–7.4) | 8.3 (2.3–20.0) |
| Month 6 | 116 | 0.9 (.0–4.7) | 0.9 (.0–4.7) | 47 | 0.0 (.0–7.5) | 0.0 (.0–7.5) |
| Month 12 | 110 | 0.0 (.0–3.3) | 0.9 (.0–5.0) | 44 | 0.0 (.0–8.0) | 2.3 (.1–12.0) |
Abbreviations: CC-1.9 µgHA + AS03B, cell-culture-derived formulation with 1.9 µg of HA plus AS03B adjuvant; CC-3.75 µgHA + AS03A, cell-culture-derived formulation with 3.75 µg of HA plus AS03A adjuvant; CC-15 µgPlainHA, cell-culture-derived formulation with 15 µg of HA without adjuvant; CI, confidence interval; HA, hemagglutinin antigen; Q-3.75 µgHA + AS03A, egg-derived formulation with 3.75 µg of HA plus AS03A adjuvant; Q-15 µgPlainHA, egg-derived formulation with 15 µg of HA without adjuvant; SCR, seroconversion rate; SPR, seroprotection rate.
a After receipt of the first dose of vaccine or placebo, unless otherwise indicated.
b Before receipt of the first dose of vaccine or placebo.