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. Author manuscript; available in PMC: 2018 Sep 1.
Published in final edited form as: Lancet Infect Dis. 2017 May 15;17(9):981–989. doi: 10.1016/S1473-3099(17)30252-9

Table 3.

Selected secondary outcomes

Cohort 1 Cohort 2 Combined



Placebo Vaccine Effect size
(95% CI)
p value Placebo Vaccine Effect size
(95% CI)
p value Placebo Vaccine Effect size
(95% CI)
p value






Cases* Incidence Cases* Incidence Cases* Incidence Cases* Incidence Cases* Incidence Cases* Incidence
Maternal

All laboratory-confirmed influenza 30 (639·4) 46·9 17 (662·4) 25·7 0·55 (0·30 to 0·99) 0·047 14 (454·0) 30·8 14 (449·4) 31·2 1·02 (0·48 to 2·18) 0·956 44 (1093·4) 40·3 31 (111·8) 27·9 0·69 (0·44 to 1·10) 0·122
Laboratory-confirmed influenza (pregnancy) 15 (260·6) 57·6 7 (271·3) 25·8 0·45 (0·18 to 1·10) 0·078 9 (159·8) 56·3 12 (160·7) 74·7 1·38 (0·56 to 3·37) 0·484 24 (420·5) 57·1 19 (431·9) 44·0 0·77 (0·42 to 1·43) 0·414
Laboratory-confirmed influenza (postpartum) 15 (378·9) 39·6 10 (391·1) 25·6 0·65 (0·28 to 1·47) 0·299 5 (294·1) 17·0 2 (288·7) 6·9 0·41 (0·08 to 2·09) 0·282 20 (672·9) 29·7 12 (679·9) 17·6 0·59 (0·28 to 1·23) 0·162

Infant

All influenza-like illness 409 (349·9) 1168·8 439 (363·6) 1207·4 1·04 (0·88 to 1·22) 0·674 328 (270·0) 1214·9 272 (258·7) 1047·5 0·87 (0·71 to 1·05) 0·145 737 (619·9) 1188·9 710 (622·3) 1140·9 0·96 (0·85 to 1·09) 0·556
Preterm (<37 weeks’ gestation) 145 of (14%) 1023 NA 137 (13%) of 1027 NA 0·94 (0·76 to 1·17) 0·584 102 (13%) of 790 NA 88 (11%) of 782 NA 0·87 (0·67 to 1·14) 0·314 247 (14%)of 1813 NA 225 (12%) of 1809 NA 0·91 (0·77 to 1·08) 0·289
SGA (intergrowth) 334 (45%) of 741 NA 327 (42%) of 764 NA 0·95 (0·85 to 1·06) 0·374 229 (41%) of 559 NA 211 of (39%) 543 NA 0·95 (0·82 to 1·10) 0·475 563 (43%) of 1300 NA 538 (41%) of 1307 NA 0·95 (0·87 to 1·04) 0·121
SGA (Alexander) 400 (51%) of 775 NA 387 (48%) of 802 NA 0·93 (0·85 to 1·03) 0·182 275 (47%) of 580 NA 250 (44%) of 573 NA 0·92 (0·81 to 1·04) 0·198 675 (50%) of 1355 NA 637 (46%) of 1375 NA 0·93 (0·86 to 1·01) 0·068
Birthweight, g 2741·0 (465·3) NA 2770·0 (440·6) NA 28·9 (−15·6 to 73·5) 0·203 2789·8 (441·8) NA 2851·8 (458·6) NA 62·0 (10·0 to 113·9) 0·019 2761·9 (455·9) NA 2803·9 (449·9) NA 42·1 (8·2 to 76·0) 0·015
Gestational age, weeks 39·4 (2·7) NA 39·4 (2·6) NA 0·002 (−0·23 to 0·23) 0·986 39·3 (2·4) NA 39·5 (2·4) NA 0·16 (−0·07 to 0·40) 0·168 39·4 (2·6) NA 39·4 (2·5) NA 0·07 (−0·09 to 0·24) 0·386

Gestational age <23 weeks and ≥50 weeks dropped because not feasible. Only weights measured within 72 h of birth are presented; weight missing or measured ≥72 h after birth were excluded. Gestational age calculated as date of birth minus date of last menstrual period (estimated recall period of 3–4 weeks). Seven livebirths in cohort 1, three placebo and four in vaccine group, excluded due to vaccination within 14 days of delivery. Nine livebirths in cohort 2, five placebo and five in vaccine group, excluded due to vaccination within 14 days of delivery. Eight dropped from SGA (Alexander) for improbable SGA and weight combination (cohort 1, four placebo, four vaccine). SGA=small for gestational age.

*

Data are n (person-years); n (%) of N for preterm (<37 weeks gestation), SGA (intergrowth), and SGA (Alexander); or mean (SD) for birthweight and gestational age.

Data are incidence per 1000 person-years.

Effect size is risk ratio for all outcomes except gestational age and birthweight, which are difference between mean values (95% CI).

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