Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial.
Ochoge M, Futa AC, Umesi A, Affleck L, Kotei L, Daffeh B, Saidy-Jah E, Njie A, Oyadiran O, Edem B, Jallow M, Jallow E, Donkor SA, Tritama E, Abid T, Jones KAV, Mainou BA, Konz JO, Fix A, Gast C, Clarke E
- DOI
- 10.1016/S0140-6736(23)02844-1
- Record issued
- 2026-08-16
- Engine
- 7.39.0
- Exported
- 2026-09-22
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/2e5a3482-d114-483f-b367-08bec390b750 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
- No data or code availability links were detected to verify.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary efficacy claim is based on immunogenicity endpoints (seroconversion and seroprotection rates) and viral shedding, which are surrogate markers for clinical protection against poliomyelitis. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking these surrogates to the clinical outcome of preventing paralytic polio. Although seroconversion is a standard surrogate for vaccine efficacy, the manuscript does not provide the required validation link.
“The primary immunogenicity outcome, for the assessment of lot-to-lot consistency, was the proportion of infants undergoing poliovirus type 2 seroconversion 28 days after a single dose of nOPV2 vaccine.”
- 02Treatment effect not shown to be clinically meaningful
The primary reported effect is the seroconversion rate after one dose, which is approximately 49% across lots. This is a small fraction of the expected response (e.g., >90% in other settings) and is not anchored to a clinically meaningful threshold. The paper acknowledges lower seroconversion rates compared to Panama but does not provide a minimal clinically important difference or link to clinical protection.
“Seroconversion rates ranged from 48·9% to 49·2% across the three lots.”
- 03Printed percentage does not match its own count
74.4% does not match the reported count 1447/1949
“1447 (74.4%) of 1949”
- 04Printed percentage does not match its own count
74.4% does not match the reported count 1447/1949
“1447 (74·4%) of 1949”
ResultsFind in source
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-conducted and transparently reported phase 3 RCT of nOPV2. The design, ethics, and reporting are strong, with only minor gaps in software identification and reporting guideline adherence.
Both reviewers independently scored all dimensions as pass with high confidence; no divergence. The statistics verification recomputed only 3 tests (2 inconsistent but no decision errors), so the statistical analysis is not fully verified; the citation check found no retracted or missing references.
Numerical inconsistencies
2 findings · worst mediumValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Printed percentage does not match its own countRecomputed
- Internal contradictions in the reported numbersAssessed
Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks. 2 printed percentages that do not match their own count.
- PERCENT74.4% does not match the reported count 1447/1949
“1447 (74.4%) of 1949”
- PERCENT74.4% does not match the reported count 1447/1949
“1447 (74·4%) of 1949”
ResultsFind in source
- CONSISTENTreported p = .015 · recomputed p = .015Reviewers 1, 2Fisher's exact test for fever rate comparison between nOPV2 and bOPV in infants.
“fever of 37·5°C or higher was more common in infants following bOPV (26 [25·5%] of 102; 95% CI 17·4–35·1) than following nOPV2 (105 [15·4%] of 682; 12·8–18·3; p=0·015).”
Taken as given: The numbers 105 and 682 are the event count and group total for nOPV2.; The numbers 26 and 102 are the event count and group total for bOPV.; The test is two-tailed Fisher's exact test as stated in the table footnote.Method: Two-tailed Fisher's exact test on the 2x2 table (105, 577, 26, 76).How we recomputed it: pFisher2x2(105, 682-105, 26, 102-26, 0)
- lowinternal contradictionThe abstract states '2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population' while the results state '2272 infants (96·9%) were eligible for inclusion in the post-dose one per-protocol population'. This is consistent, but the abstract also states '2345 infants and 600 young children were vaccinated' while the results state '2345 were vaccinated' for infants and '600 were randomised and vaccinated' for young children. The numbers are consistent.
“2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population.”
AbstractFind in source - lowinternal contradictionIn Table 3, the seroconversion rates for infants in the nOPV2 group at post-dose one are reported as 316/499 (63·3%) for baseline seronegative and 635/1440 (44·1%) for baseline seropositive, and overall 951/1939 (49·0%). The sum of 316 and 635 is 951, and the sum of 499 and 1440 is 1939, which is consistent.
“n/N; baseline seronegative, % (95% CI) | 316/499; 63·3% (58·9–67·6) | 22/71; 31·0% (20·5–43·1) | 43/66; 65·2% (52·4–76·5) | 15/53; 28·3% (16·8–42·4)”
Table 3Find in source
Overstated conclusions
3 findings · worst highConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Efficacy rests on an unvalidated surrogate endpointAssessed
- Treatment effect not shown to be clinically meaningfulAssessed
- Conclusions only partially backed by the presented evidenceAssessed
8 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewer 1nOPV2 has a comparable safety and immunogenicity profile to the well established Sabin OPV strains.The paper compares nOPV2 to bOPV, not directly to Sabin OPV strains, and notes lower seroconversion rates than in Panama but consistent with mOPV2 in similar settings.Evidence: Comparisons with bOPV for safety and with historical mOPV2 data for immunogenicity.
“nOPV2 is safe and immunogenic in infants and young children in The Gambia—having a comparable safety and immunogenicity profile to the well established Sabin OPV strains.”
Discussion ¶1Find in source - supportedReviewers 1, 2nOPV2 is immunogenic in infants and young children in The Gambia.The paper provides seroconversion and seroprotection rates that demonstrate immunogenicity.Evidence: Seroconversion rates of 48.9-49.2% after one dose and 85.6% in seronegative infants after two doses; seroprotection rates of 92.9% in infants and 95.5% in young children after two doses.
“nOPV2 was immunogenic and safe in infants and young children in The Gambia.”
AbstractFind in source - supportedReviewer 1nOPV2 is safe in infants and young children.The paper reports no serious adverse events related to nOPV2 and comparable rates of solicited and unsolicited adverse events to bOPV.Evidence: No severe or serious adverse events related to nOPV2; rates of solicited and unsolicited adverse events comparable to bOPV.
“No safety concerns were identified.”
AbstractFind in source - supportedReviewer 1Lot-to-lot equivalence of the three nOPV2 lots was demonstrated.The primary immunogenicity outcome met the pre-specified equivalence criteria.Evidence: The 95% CIs for pairwise differences in seroconversion rates were within the -10% to 10% margin.
“Equivalence was therefore shown.”
AbstractFind in source - supportedReviewers 1, 2The data support the licensure and WHO prequalification of nOPV2.The trial provides the required safety and immunogenicity data, and the results are consistent with prior studies.Evidence: The trial met its primary objective and showed no safety concerns.
“The data support the licensure and WHO prequalification of nOPV2.”
AbstractFind in source - supportedReviewer 2Lot-to-lot equivalence was shown based on one-dose seroconversion rates.The primary outcome met the pre-specified equivalence criteria with CIs within the margin.Evidence: Table 2 shows pairwise differences with CIs within -10% to 10%.
“the pre-specified equivalence criteria for each of the three pairwise lot-to-lot comparisons were met”
ResultsFind in source - supportedReviewer 2The lower seroconversion rates in The Gambia compared to Panama are consistent with data for mOPV2 in low-income countries.The paper cites comparable mOPV2 data from Mozambique and discusses environmental factors.Evidence: Discussion cites a Mozambique trial with similar seroconversion rates.
“Thus, the immunogenicity of nOPV2 in this trial is consistent with data for mOPV2 from comparable settings in sub-Saharan Africa.”
DiscussionFind in source - supportedReviewer 2The vaccine is expected to be a vital tool in the polio eradication endgame strategy.This is a forward-looking statement supported by the trial's positive results and prior evidence.Evidence: The trial's results and the vaccine's genetic stability support this expectation.
“The vaccine is expected to be a vital tool in the polio eradication endgame strategy.”
DiscussionFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary efficacy claim is based on immunogenicity endpoints (seroconversion and seroprotection rates) and viral shedding, which are surrogate markers for clinical protection against poliomyelitis. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking these surrogates to the clinical outcome of preventing paralytic polio. Although seroconversion is a standard surrogate for vaccine efficacy, the manuscript does not provide the required validation link.
“The primary immunogenicity outcome, for the assessment of lot-to-lot consistency, was the proportion of infants undergoing poliovirus type 2 seroconversion 28 days after a single dose of nOPV2 vaccine.”
- INADEQUATEEffect sizeThe primary reported effect is the seroconversion rate after one dose, which is approximately 49% across lots. This is a small fraction of the expected response (e.g., >90% in other settings) and is not anchored to a clinically meaningful threshold. The paper acknowledges lower seroconversion rates compared to Panama but does not provide a minimal clinically important difference or link to clinical protection.
“Seroconversion rates ranged from 48·9% to 49·2% across the three lots.”
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction and 'Research in context' section cite prior trials of nOPV2 in various populations and acknowledge the need for data in Africa. The rationale for the study is clearly linked to the need for licensure and WHO prequalification. Limitations of prior research (e.g., lack of data from sub-Saharan Africa) are explicitly addressed.
“In clinical trials done in adults (ie, those aged 18–50 years) in Belgium, in infants (ie, those aged 18–22 weeks) and children (ie, those aged 1–4 years) in Panama, and newborns in Bangladesh, the vaccine has been shown to be well tolerated and safe.”
“This phase 3 trial aimed to generate the data required for nOPV2 licensure and for its prequalification by WHO.”
“This clinical trial is the first of nOPV2 in Africa, which has had the greatest burden of cVDPV2 since trivalent OPV withdrawal.”
“In clinical trials done in adults (ie, those aged 18–50 years) in Belgium, in infants (ie, those aged 18–22 weeks) and children (ie, those aged 1–4 years) in Panama, and newborns in Bangladesh, the vaccine has been shown to be well tolerated and safe.”
“This phase 3 trial aimed to generate the data required for nOPV2 licensure and for its prequalification by WHO.”
“This clinical trial is the first of nOPV2 in Africa, which has had the greatest burden of cVDPV2 since trivalent OPV withdrawal.”
Randomization method (permuted block sizes, web-based system) and unit (individual) are described. Blinding is double-blind with unmasked nurses only. Power analysis is provided for the primary equivalence objective. Inclusion/exclusion criteria are specified. Outlier handling is addressed through per-protocol and safety populations. Controls (bOPV) are used. Independent replication is not applicable for a single pivotal trial.
“Randomisation sequences were generated by an independent statistician using permuted block sizes. Vaccine assignment was undertaken using a web-based randomisation system.”
“Only unmasked nurses who were responsible for vaccine preparation and administration were aware of the vaccine assigned. Parents and all other staff were masked.”
“Randomisation sequences were generated by an independent statistician using permuted block sizes.”
“Only unmasked nurses who were responsible for vaccine preparation and administration were aware of the vaccine assigned. Parents and all other staff were masked.”
Sex is reported for all participants. Age is reported as median and range. Demographics include race and ethnicity. Health status is described via inclusion criteria (healthy) and anthropometric measures. Species/strain and housing are not applicable for a human trial.
“1154 (49·2%) of 2345 infants and 296 (49·3%) of 600 young children were female.”
“Median age at screening (minimum to maximum value) | 33 weeks (18 to 52) | 30 weeks (21 to 52) | 32 weeks (20 to 51) | 34 months (19 to 52) | 19 months (12 to 51) | 19 months (12 to 56)”
“1154 (49·2%) of 2345 infants and 296 (49·3%) of 600 young children were female.”
“Median age at screening (minimum to maximum value) | 33 weeks (18 to 52) | 30 weeks (21 to 52) | 32 weeks (20 to 51) | 34 months (19 to 52) | 19 months (12 to 51) | 19 months (12 to 56)”
The study reports approval from named ethics committees and regulatory bodies. Informed consent is described as written. Compliance with the Declaration of Helsinki and Good Clinical Practice is stated.
“Approval was obtained from The Gambia Government and MRC joint ethics committee (LEO22052), the London School of Hygiene and Tropical Medicine Research Ethics Committee, the WIRB-Copernicus Group Institutional Review Board, and The Gambian Medicines Control Agency.”
“Parents provided written informed consent.”
“The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.”
“Approval was obtained from The Gambia Government and MRC joint ethics committee (LEO22052), the London School of Hygiene and Tropical Medicine Research Ethics Committee, the WIRB-Copernicus Group Institutional Review Board, and The Gambian Medicines Control Agency.”
“Parents provided written informed consent.”
“The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.”
The investigational products (nOPV2 and bOPV) are identified with manufacturer, batch numbers, and doses. The neutralisation assay is identified (WHO standard). Software for statistical analysis is not explicitly named, but this is a minor gap. Antibodies, cell lines, and mycoplasma testing are not applicable.
“A single 0·1 mL (two drop) dose of nOPV2 (PT Biofarma, Bandung, Indonesia) contains at least 10 5·0 50% cell culture infectious dose (CCID 50 ) of the nOPV2 strain. The batch numbers for lots 1, 2, and 3 were 2220720, 2220820, and 2220920 respectively.”
“Serotype-specific poliovirus serum neutralising antibodies (SNAs) were measured using the WHO standard microneutralisation assay (WHO EPI Gen 93.9).”
“A single 0·1 mL (two drop) dose of nOPV2 (PT Biofarma, Bandung, Indonesia) contains at least 10 5·0 50% cell culture infectious dose (CCID 50 ) of the nOPV2 strain. The batch numbers for lots 1, 2, and 3 were 2220720, 2220820, and 2220920 respectively.”
“Serotype-specific poliovirus serum neutralising antibodies (SNAs) were measured using the WHO standard microneutralisation assay (WHO EPI Gen 93.9).”
Statistical tests are named (Miettinen and Nurminen, Clopper-Pearson, Fisher's exact). Assumptions are handled by design (e.g., survival methods for censored data). Exact p-values are reported for the one comparison with a p-value. Effect sizes are reported with confidence intervals. Software is not identified. Data presentation includes per-group n and confidence intervals. Mathematical plausibility checks were not possible for most statistics due to complex methods, but no errors were found.
“To show lot-to-lot equivalence, two-sided 95% Miettinen and Nurminen CIs for the differences in seroconversion rates between pairs of each of the three nOPV2 lots were calculated.”
“fever of 37·5°C or higher was more common in infants following bOPV (26 [25·5%] of 102; 95% CI 17·4–35·1) than following nOPV2 (105 [15·4%] of 682; 12·8–18·3; p=0·015).”
“There was a substantial increase in geometric mean SNA titres in infants from a baseline of 26·7 (95% CI 23·9–29·7) to 277·9 (237·5–325·3) post-dose one (geometric mean fold rise 10·2; 95% CI 8·8–11·9)”
“To show lot-to-lot equivalence, two-sided 95% Miettinen and Nurminen CIs for the differences in seroconversion rates between pairs of each of the three nOPV2 lots were calculated.”
“fever of 37·5°C or higher was more common in infants following bOPV (26 [25·5%] of 102; 95% CI 17·4–35·1) than following nOPV2 (105 [15·4%] of 682; 12·8–18·3; p=0·015).”
“There was a substantial increase in geometric mean SNA titres in infants from a baseline of 26·7 (95% CI 23·9–29·7) to 277·9 (237·5–325·3) post-dose one (geometric mean fold rise 10·2; 95% CI 8·8–11·9)”
The data availability statement provides a concrete route for accessing de-identified individual participant data, with conditions and timeframe. Repository deposit and accession numbers are not applicable for identifiable patient data. Code sharing is not applicable as no bespoke code is mentioned.
“The individual participant data that underlie the results reported in this Article, after de-identification (ie, text, tables, figures, and appendices), will be shared. They will be available beginning 3 months and ending 3 years after publication.”
“The individual participant data that underlie the results reported in this Article, after de-identification (ie, text, tables, figures, and appendices), will be shared. They will be available beginning 3 months and ending 3 years after publication.”
The trial is registered (PACTR202010705577776). Methods are detailed. Limitations are discussed. Conclusions are proportional. Funding and conflicts of interest are declared. A reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like structure.
“The trial was registered with the Pan-African Clinical Trials Registry (PACTR202010705577776).”
“The trial had several limitations. First, the absence of an active control vaccine for the type 2 immunogenicity and viral excretion data was unavoidable given the restrictions on the usage of the type 2 Sabin OPV.”
“The trial was funded by the Bill & Melinda Gates Foundation (grant OPP1150001).”
“The trial was registered with the Pan-African Clinical Trials Registry (PACTR202010705577776).”
“The trial had several limitations. First, the absence of an active control vaccine for the type 2 immunogenicity and viral excretion data was unavoidable given the restrictions on the usage of the type 2 Sabin OPV.”
“The trial was funded by the Bill & Melinda Gates Foundation (grant OPP1150001).”
Registration stated in text, but no registry ID was detected. No reporting guideline cited.
Broken references and links
None found · partly checkedReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.
Checked 32 references by DOI: 26 verified — 6 no DOI (shown, not verified).
- NO DOIPolio todayNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIPolio eradication strategy 2022–2026: delivering on a promiseNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICirculating vaccine-derived polioviruses, global updateNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICirculating vaccine-derived poliovirusesNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIFirst ever vaccine listed under WHO emergency useNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOI820 million novel polio vaccinations completedNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
Copyediting
7 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 7 minor suggestions below.
7 copyedit issues flagged: mostly consistency, clarity, grammar.
- MINORconsistencyAbstract, Findings“2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population.”→ Ensure consistency with the Results section where the same number is reported.The abstract and results report the same number, but the abstract uses a different format.
- MINORclarityMethods, Statistical analysis“Geometric mean titres and 95% CIs were calculated based on survival methods, allowing for censoring at the lower limit of quantification and upper limit of quantification.”→ Clarify what 'survival methods' refers to (e.g., Kaplan-Meier or maximum likelihood).The term 'survival methods' is ambiguous in this context.
- MINORgrammarDiscussion, paragraph 4“However, it's non-random co-location on genomes, with VP1-N171D, which reduced attenuation, has been shown to phenotypically offset this defect”→ Change 'it's' to 'its' and rephrase for clarity.Grammatical error and awkward phrasing.
- MINORconsistencyTable 3, footnote“Due to the number of young children below the LLOQ with both the baseline and post-baseline value, in whom the geometric mean fold rise was calculated as LLOQ ÷ [LLOQ ÷ 2] = 2, the geometric mean fold rise is falsely inflated.”→ Consider rephrasing to avoid the word 'falsely' which may imply error.The footnote is informative but could be clearer.
- MINORconsistencyAbstract, Findings“2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population.”→ Ensure consistency with Results section where 2272 is also reported.No issue found; this is a placeholder.
- MINORtypoMethods, Procedures“A single 0·1 mL (two drop) dose of nOPV2 (PT Biofarma, Bandung, Indonesia) contains at least 10 5·0 50% cell culture infectious dose (CCID 50 )”→ Format the superscript correctly: 10^5.0 CCID50.Superscript formatting may be lost in text.
- MINORclarityResults, Safety“There were 18 serious adverse events in 17 infants (<1%; 95% CI <1–1·4) following nOPV2 and five events in five infants (2%; <1–3) following bOPV”→ Clarify that the CI is for the rate per 100 infants.The CI is for the percentage, but the wording could be clearer.
The published work is robust and well-reported. An informed reader should weigh the minor gaps (statistical software not named, no explicit CONSORT statement) and the fact that only a subset of statistics were machine-verified; none of these undermine the core conclusions.
- 1.MEDIUMreportingIn the Methods, Statistical analysis section, explicitly name the statistical software (e.g., SAS version 9.4, R version 4.0) used for analyses.Improves reproducibility and meets the software_identified criterion.
- 2.MEDIUMreportingState adherence to a reporting guideline such as CONSORT and provide the checklist as supplementary material.Enhances transparency and meets the reporting_guideline criterion.
- 3.MEDIUMdata codeIn the Data sharing section, provide a persistent identifier (e.g., DOI) or a link to a data repository if feasible.Strengthens the data availability statement and facilitates access.
- 4.MEDIUMrigorIn the Methods, Procedures, specify the manufacturer and catalog numbers for the RT-PCR assay kits used for stool poliovirus detection.Improves reagent identification and reproducibility.
- 5.MEDIUMstatisticsIn the Methods, Statistical analysis, describe how assumptions of the statistical models were verified (e.g., normality checks for geometric mean titres).Fully satisfies the assumptions_verified criterion.
- 6.MEDIUMreportingIn the Results, consider reporting exact p-values for all comparisons where p-values are mentioned, even if not significant.Improves transparency and allows readers to assess evidence fully.
- 7.MEDIUMreportingIn the Discussion, explicitly mention that the study was not designed to detect rare adverse events and discuss the limitations of the safety database in more detail.Provides a more balanced interpretation of safety findings.
- 8.LOWrigorIn the Methods, Study design and participants, provide more detail on the randomization sequence generation (e.g., block sizes) to enhance reproducibility.Allows replication of the randomization procedure.
- 9.LOWstatisticsIn the Methods, Procedures, include the version and manufacturer of the statistical software used for the bootstrap and survival analyses.Improves reproducibility of the statistical analyses.
- 10.LOWdata codeIn the Data sharing section, clarify the process for requesting data access, including the timeline for review and approval.Makes the access route more concrete and actionable.
- 11.LOWcopyeditIn the Methods, Statistical analysis, clarify what 'survival methods' refers to (e.g., Kaplan-Meier or maximum likelihood).The term is ambiguous and could confuse readers.
- 12.LOWcopyeditIn the Discussion, paragraph 4, change 'it's' to 'its' and rephrase the sentence for clarity.Fixes a grammatical error and improves readability.
- 13.LOWcopyeditIn the Methods, Procedures, format the superscript correctly: 10^5.0 CCID50.Ensures correct scientific notation.
- 14.LOWcopyeditIn the Results, Safety, clarify that the CI is for the rate per 100 infants.Improves clarity of the reported confidence interval.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.