Table 2.
A/H1N1pdm09 |
A/H3N2 |
B/Yamagata |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
Single-dose group | Double-dose group | p value | Single-dose group | Double-dose group | p value | Single-dose group | Double-dose group | p value | ||
Mothers* | 230 | 230 | ·· | 230 | 230 | ·· | 230 | 230 | ·· | |
HAI GMTs at baseline | 9·6 (8·5–10·9) | 9·5 (8·4–10·8) | 0·92 | 11·8 (10·5–13·3) | 13·3 (11·7–15·1) | 0·19 | 5·9 (5·6–6·2) | 6·1 (5·7–6·5) | 0·39 | |
HAI GMTs at 28–35 days after visit 1† | 39·5 (33·1–47·1) | 60·8 (51·2–72·2) | 0·001 | 37·8 (32·3–44·1) | 52·7 (45·4–61·1) | 0·003 | 13·0 (11·6–14·5) | 16·6 (14·7–18·8) | 0·004 | |
HAI ≥1/40 at baseline | 33 (14%) | 29 (13%) | 0·59 | 34 (15%) | 50 (22%) | 0·053 | 4 (2%) | 4 (2%) | 1·0 | |
HAI ≥1/40 at 28–35 days after visit 1 | 142 (62%) | 171 (74%) | 0·004 | 131 (57%) | 163 (71%) | 0·002 | 46 (20%) | 71 (31%) | 0·007 | |
Seroconversion at 28–35 days after visit 1 | 113 (49%) | 150 (65%) | <0·001 | 95 (41%) | 120 (52%) | 0·019 | 41 (18%) | 67 (29%) | 0·004 | |
Infants overall‡ | 200 | 197 | ·· | 200 | 197 | ·· | 200 | 197 | ·· | |
HAI GMTs at age ≤7 days | 29·7 (24·7–35·5) | 38·5 (32·1–46·1) | 0·046 | 23·3 (19·7–27·5) | 26·2 (22·3–30·9) | 0·32 | 13·0 (11·7–14·4) | 14·4 (12·8–16·2) | 0·20 | |
HAI ≥1/40 at age ≤7 days | 99 (50%) | 118 (60%) | 0·037 | 77 (39%) | 90 (46%) | 0·15 | 32 (16%) | 37 (19%) | 0·47 |
Data are n, n (%), or GMTs with 95% CI in parentheses. GMTs=geometric means titres. HAI=haemagglutination inhibition antibody.
Only women who attended the visits within the protocol-defined time periods were included.
GMTs significantly higher than at baseline for all comparisons.
Only infants born ≥28 days after their mothers had been vaccinated and with blood sample collected in the first 7 days of life were included.