TABLE 3.
Hospitalizations, deaths, and severe infections by intervention groupi
| Parameter | Intervention group | ||||
|---|---|---|---|---|---|
| Placebo | LP1 | LP1 + FOS | LP7 | LP7 + FOS | |
| Participants, N | 104 | 105 | 103 | 104 | 103 |
| Total hospitalizations during IP period,a,b n | 7 | 5 | 7 | 8 | 6 |
| Total hospitalizations up to 60 days,c inclusive, n | 10 | 9 | 12 | 13 | 10 |
| Total hospitalizations between 61 days and 180 days,c inclusive, n | 1 | 8 | 7 | 3 | 3 |
| Hospitalizationsa up to 180 daysc | |||||
| Infants with at least one event, n (%) | 11 (11) | 13 (12) | 16 (16) | 15 (14) | 12 (12) |
| Number of events, n | 11 | 17 | 19 | 16 | 13 |
| Person-time at risk (infant-days) | 17,824 | 18,238 | 18,272 | 18,082 | 18,250 |
| Incidence rate (95% CI), events per 1,000 infant-days | 0.62 (0.32, 1.1) | 0.93 (0.56, 1.4) | 1.0 (0.64, 1.6) | 0.88 (0.52, 1.4) | 0.71 (0.39, 1.2) |
| Hazard ratio (95% CI) | Ref | 1.5 (0.66, 3.3) | 1.7 (0.79, 3.5) | 1.4 (0.68, 3.0) | 1.1 (0.52, 2.5) |
| Duration of hospitalization (days),d median (25th, 75th) | 3.9 (3.1, 4.8) | 5.9 (2.9, 6.9) | 4.6 (2.1, 5.9) | 5.1 (3.9, 6.9) | 3.8 (3.0, 7.0) |
| Hospitalizations associated with gastrointestinal (GI) symptoms/signs up to 180 dayse | |||||
| Infants with at least one event, n (%) | 2 (1.9) | 5 (4.8) | 5 (4.9) | 2 (1.9) | 2 (1.9) |
| Number of events, n | 2 | 5 | 5 | 2 | 2 |
| Deaths,f n (%) | 0 (0) | 2 (1.9) | 0 (0) | 1 (0.96) | 0 (0) |
| Deaths up to 60 days, n (%) | 0 (0) | 1 (0.95) | 0 (0) | 1 (0.96) | 0 (0) |
| SIsg up to 60 days | |||||
| Total up to 60 days,c inclusive | |||||
| Infants with at least one event, n (%) | 6 (5.8) | 5 (4.8) | 5 (4.9) | 5 (4.8) | 4 (3.9) |
| Number of events, n | 6 | 6 | 6 | 5 | 4 |
| Person-time at risk (infant-days) | 5,870 | 6,043 | 6,018 | 5,997 | 6,035 |
| Incidence rate (95% CI), events per 1,000 infant-days | 1.0 (0.41, 2.1) | 0.99 (0.39, 2.0) | 1.0 (0.40, 2.0) | 0.83 (0.30, 1.8) | 0.66 (0.21, 1.5) |
| Hazard ratio (95% CI)h | Ref | 0.97 (0.29, 3.2) | 0.96 (0.29, 3.2) | 0.82 (0.26, 2.6) | 0.64 (0.19, 2.2) |
| After first IP dose and up to 60 days,b inclusive | |||||
| Infants with at least one event, n (%) | 6 (5.9) | 5 (4.8) | 5 (4.9) | 4 (3.8) | 4 (3.9) |
| Number of events, n | 6 | 6 | 6 | 4 | 4 |
| During IP perioda,b | |||||
| Infants with at least one event, n (%) | 3 (3.0) | 2 (1.9) | 1 (1.0) | 3 (2.9) | 0 (0) |
| Number of events, n | 3 | 2 | 1 | 3 | 0 |
| # SI events associated with Lactobacillus spp.,c n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Non-injury deathsf or SIs | |||||
| Total up to 60 daysc | |||||
| Infants who died or had at least one SI, n (%) | 6 (5.8) | 5 (4.8) | 5 (4.9) | 5 (4.8) | 4 (3.9) |
| Number of events, n | 6 | 7 | 6 | 5 | 4 |
| Person-time at risk (infant-days) | 5,870 | 6,043 | 6,018 | 5,997 | 6,035 |
| Incidence rate (95% CI), events per 1,000 infant-days | 1.0 (0.41, 2.1) | 1.2 (0.50, 2.2) | 1.0 (0.40, 2.0) | 0.83 (0.30, 1.8) | 0.66 (0.21, 1.5) |
| Hazard ratio (95% CI)g | Ref | 1.1 (0.31, 4.1) | 0.97 (0.29, 3.2) | 0.82 (0.26, 2.6) | 0.64 (0.19, 2.2) |
| After first IP dose and up to 60 daysb | |||||
| Infants who died or had at least one SI, n (%) | 6 (5.9) | 5 (4.8) | 5 (4.9) | 4 (3.8) | 4 (3.9) |
| Number of events, n | 6 | 7 | 6 | 4 | 4 |
| During IP perioda,b | |||||
| Infants who died or had at least one SI, n (%) | 3 (3.0) | 2 (1.9) | 1 (1.0) | 3 (2.9) | 0 (0) |
From day of the first IP dose up to 3 days after the last dose.
Among infants who received at least one dose of the IP. NOverall = 515; NPlacebo = 101; NLP1 = 105; NLP1+FOS = 103; NLP7 = 104; and NLP7+FOS = 102.
Among all infants, irrespective of number of doses of IP received.
Includes all hospitalizations, including multiple separate hospitalizations of the same infant.
Among infants with at least one event. For infants with more than one event, only the first event was included in this analysis.
All deaths were due to non-injury-related causes.
Severe infection (SI) events up to 60 days included all six cases of hospitalized lower respiratory tract infection (LRTI) events identified in the trial: two in placebo group; one in LP1 group; two in LP1 + FOS group; 0 in LP7 group; and one in LP7 + FOS group.
Cox proportional hazard models adjusting for hospital enrollment site (see text for details).
IP, investigational product; CI, confidence intervals.