Safety and Efficacy of a Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine
New England Journal of Medicine, 2006 · paper · Clinical trials
A placebo-controlled trial of an oral pentavalent rotavirus vaccine in about 68,000 infants. The vaccine cut rotavirus-related hospitalizations and emergency visits by 94.5% and showed no excess intussusception risk compared with placebo.
2 findings
Reference or label Reference 11 (Kramarz et al.) is printed "Pediatr Infect Dis J 2001;204:10-6."; volume 204 cannot be right for this journal in 2001.
- p. 10 Reference list, ref. 11 (Kramarz et al.)
Infect Dis J 2001;204:10-6.
Judge's note: Viewed the reference list on page 10: the entry reads "2001;204:10-6", so this is not an extraction artefact. The same list gives Pediatr Infect Dis J volume 17 for 1998 (refs. 17 and 25) and volume 21 for 2002 (ref. 24), which puts 2001 at volume 20. The printed string is consistent with the first digit of the page number having been attached to the volume, giving 2001;20:410-6. The volume follows from the paper's own reference list; the first page 410 is inferred from re-splitting the printed digits and was not checked against the journal.
Second check: another model agreed
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Wording Figure 1A splits "115 Potential cases of intussusception reported" into "30 Positively adjudicated cases" and "85 Negatively adjudicated cases", yet the legend says "One potential case of intussusception that was reported could not be adjudicated because radiographs were not available"; the figure does not show where that case is counted.
- p. 3 Figure 1, panel A, top box
115 Potential cases of intussusception reported
- p. 3 Figure 1, panel A
85 Negatively adjudicated cases
- p. 3 Figure 1 legend
One potential case of intussuscep- tion that was reported could not be adjudicated
- p. 3 Figure 1 caption
could not be adjudicated because radiographs were not available
Only the authors can say what is right here.
Judge's note: Viewed page 3. 30 + 85 = 115, so no box is left for an unadjudicated case; the sub-boxes also reconcile (27 + 3 = 30; vaccine findings sum to 40, placebo findings to 45, 40 + 45 = 85). The legend says the unadjudicated case was a placebo recipient and defines negatively adjudicated cases as "those not confirmed to be cases of intussusception", so it may sit among the 45 placebo cases (which include "2 With intussusception"), or it may be outside the 115. Searched the article text for a statement settling this; none found. Ambiguity only; the authors can say which.
Second check: another model agreed
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3 minor (typos and the like; most checked by the judge only)
Typo The Figure 1 legend twice names the "data safety and monitoring board", while the methods and results call the same body the "data and safety monitoring board".
- p. 3 Figure 1 legend, Panel A description
of the data safety and monitoring board to discontinue enrollment
- p. 3 Figure 1 legend, Panel C description
as recommended by the data safety and monitoring board
- p. 4 Methods, heading and text on adjudication
data and safety monitoring board
- p. 2 Methods, Study Design
members of the data and safety monitoring board
Judge's note: Viewed page 3: the legend reads "the recommendation of the data safety and monitoring board to discontinue enrollment" and "as recommended by the data safety and monitoring board". The text on pages 2, 4 and 6 (study design, the section heading and three further uses) has "data and safety monitoring board". Only one such board is described. Wording inconsistency, meaning unchanged.
Second check: none (judge only)
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Typo Table 1, Clinical-Efficacy Substudy, White row: "1854 (65.3)" beside "1,885 (66.3)"; the only four-digit count in the substudy columns printed with a thousands comma.
- p. 7 Table 1, Clinical-Efficacy Substudy, Placebo Group, White
1,885 (66.3)
- p. 7 Table 1, Clinical-Efficacy Substudy, White row
1854 (65.3) 1,885 (66.3)
- p. 7 Table 1, Detailed Safety Substudy White row
3052 (63.2)
Judge's note: Viewed Table 1 on page 7. The large-scale columns use commas throughout (they contain five-digit numbers). The four substudy columns print four-digit counts without a comma (4826, 4821, 2841, 2845, 2482, 2491, 2344, 2330, 3052, 3031, 1462, 1467, 1379, 1378, 1854), except "1,885". Cosmetic.
Second check: none (judge only)
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Typo Reference 3 (Moulton et al.) gives its pages as "1998;178:1562-66.", where every other entry shortens the last page to the changed digits (by that style, 1562-6).
- p. 10 Reference list, ref. 3 (Moulton et al.)
Dis 1998;178:1562-66.
Judge's note: Viewed the reference list on page 10: the entry reads "1562-66". Other entries on the page follow the abbreviated style: "1602-9", "1022-8", "1205-9", "504-11", "1413-21", "2207-22", "334-40". Style inconsistency only; the pages identified are the same.
Second check: none (judge only)