Rigor Reviewed

Rigor-Reviewed Manuscript

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.

Name: Adcurare Rigor Record — 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.
Item: 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.
Rating: 96
Author: Adcurare

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

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Adcurare Rigor Review — 4.25★ (Strong), 0 critical, 3 high issues for “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.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.6.0Source: full text

Not verified in this report

No data or code availability links were detected to verify.

Problems surfaced2 types

Summary statistic impossible for the stated N (GRIM/GRIMMER)
Data/code availability incomplete

This Adcurare Rigor Review uses AI 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 phase 3 RCT of nOPV2 is methodologically rigorous overall, with strong study design, ethical approvals, and biological variable reporting. Minor but important pre-submission improvements are needed in reporting transparency (CONSORT statement, table corrections), statistical analysis (software identification), and data/code availability (code sharing statement).

All three independent reviewers (same model, AI) agreed on most dimensions; minor divergence on statistical analysis and reporting transparency was resolved by weighing the specific evidence. The copyedit report identified a likely typo in Table 1 (months vs weeks). Citation check found no retracted or missing references. Statistics recomputation checked 4 tests; 3 consistent, 1 inconsistent (but not flagged as error by reviewer). The paper's full text was available.

10 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 3 tests: 3 consistent, 0 inconsistent, 3 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (GRIM/GRIMMER).

Reporting

Eight Dimensions7 pass · 1 warn

The Introduction and 'Research in context' sections extensively cite prior work on the polio eradication strategy, the safety and immunogenicity data from Phase 1/2 trials in Belgium, Panama, and Bangladesh, and the problem of cVDPV2 outbreaks. The rationale linking the need for improved genetic stability of type 2 OPV to the trial's objectives is clearly stated. Limitations of prior research, such as the lack of data from Africa and the need for lot-to-lot consistency data, are explicitly addressed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its scientific foundation by citing prior research on nOPV2, the problem of cVDPV2, and the rationale for conducting the trial in Africa. Limitations of prior work are acknowledged and addressed.

Evidence

direct quote[Introduction, paragraphs 4-6]

“On the basis of supportive pre-clinical data, the vaccine was tested in phase 1 and phase 2 trials in adults (ie, those aged 18–50 years) in Belgium, in phase 2 trials in children aged 1–4 years in Panama, in phase 2 trials in infants aged 18–22 weeks in Panama, and in phase 2 trials in newborns in Bangladesh.”

direct quote[Introduction, paragraph 6]

“This phase 3 trial aimed to generate the data required for nOPV2 licensure and for its prequalification by WHO.”

paraphrase[Discussion, paragraph 1]

“The trial provides the first nOPV2 data from sub-Saharan Africa, the region with the greatest cVDPV2 burden, directly addressing a key gap.”

PASSReviewer 2· 95% conf

The scientific premise is well established: the paper thoroughly reviews prior literature on poliovirus, OPV, and cVDPV2, clearly explains the rationale for engineering nOPV2, and situates this trial as a necessary step for licensure and WHO prequalification.

Evidence

direct quote[Introduction, paragraph 2]

“The novel OPV type 2 (nOPV2) strain has been engineered... tested in phase 1 and phase 2 trials in adults... in Belgium, in phase 2 trials in children... in Panama... in newborns in Bangladesh.”

direct quote[Abstract]

“Novel oral poliovirus vaccine type 2 (nOPV2) has been engineered to improve the genetic stability of Sabin oral poliovirus vaccine (OPV) and reduce the emergence of circulating vaccine-derived polioviruses.”

direct quote[Evidence before this study, subsection 'Added value of this study']

“This clinical trial is the first of nOPV2 in Africa, which has had the greatest burden of cVDPV2 since trivalent OPV withdrawal.”

PASSReviewer 3· 95% conf

The paper establishes a strong scientific premise by citing extensive prior research on polio vaccines, the problem of circulating vaccine-derived polioviruses, and prior nOPV2 trials, with a clear rationale for the current study.

Evidence

direct quote[Introduction, paragraph 4]

“In all age groups, nOPV2 was well tolerated and safe. In adults, children, and infants, serological responses to nOPV2 were similar to those generated in historic mOPV2 controls.”

direct quote[Introduction, paragraph 5]

“This phase 3 trial aimed to generate the data required for nOPV2 licensure and for its prequalification by WHO.”

direct quote[Research in context, Added value of this study]

“This clinical trial is the first of nOPV2 in Africa, which has had the greatest burden of cVDPV2 since trivalent OPV withdrawal.”

The trial is explicitly described as double-blind and randomised (matching the key criteria for an interventional human study: randomization_method, randomization_unit, blinding_levels, power_analysis, inclusion_exclusion). Randomisation sequences were generated by an independent statistician using permuted block sizes, with a web-based system. Blinding is adequate: only unmasked nurses were aware of the vaccine; parents and all other staff were masked. An a priori power analysis is provided (90% power to show equivalence). Inclusion and exclusion criteria are detailed in the Methods. Pre-specified analysis populations are defined. As per applicability, for a human RCT: replicate_distinction (biological-vs-technical) is not applicable for the primary outcome of seroconversion in individual subjects; controls (positive/negative wet-lab controls) are not applicable as the comparator is bOPV and is assessed via the design; independent_replication (separate replication cohort) is not applicable as this is a pivotal trial. outlier_handling maps to the pre-specified analysis population, which is described (per-protocol, safety, full analysis populations). All applicable sub-criteria are adequate.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous: a double-blind, randomised, controlled phase 3 trial with prespecified equivalence criteria, sample size/power calculations, and detailed inclusion/exclusion criteria. Randomisation and masking are well described.

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation sequences were generated by an independent statistician using permuted block sizes. Vaccine assignment was undertaken using a web-based randomisation system.”

direct quote[Methods, Randomisation and masking]

“Only unmasked nurses who were responsible for vaccine preparation and administration were aware of the vaccine assigned. Parents and all other staff were masked.”

direct quote[Methods, Statistical analysis]

“A sample size of 670 infants per nOPV2 group was calculated to provide at least 90% power to show equivalence of the three manufacturing lots based on seroconversion rates, using an equivalence interval of –10% to 10%.”

PASSReviewer 2· 90% conf

The trial design is rigorous: randomization with clear methods, adequate blinding, pre-specified sample size calculations, and well-defined inclusion/exclusion criteria.

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation sequences were generated by an independent statistician using permuted block sizes. Vaccine assignment was undertaken using a web-based randomisation system.”

direct quote[Methods, Randomisation and masking]

“Only unmasked nurses who were responsible for vaccine preparation and administration were aware of the vaccine assigned. Parents and all other staff were masked.”

direct quote[Methods, Statistical analysis]

PASSReviewer 3· 95% conf

The study design is rigorous: a double-blind, randomised controlled trial with adequate blinding, randomisation, a pre-specified sample size calculation, and clearly defined inclusion/exclusion criteria.

Evidence

direct quote[Methods, Study design and participants]

“This was a single-centre, double-blind, randomised, controlled, phase 3 trial.”

direct quote[Methods, Randomisation and masking]

“Randomisation sequences were generated by an independent statistician using permuted block sizes. Vaccine assignment was undertaken using a web-based randomisation system.”

direct quote[Methods, Statistical analysis]

Sex is reported for all groups. Age is reported as median (range) for infants and young children. Health status (weight for height Z score) is provided. Race (Black African) and ethnicity (Mandinka, Wolof, etc.) are detailed in demographics. For a human interventional trial, species_strain_source and housing_conditions are not applicable. Sex is not justified because the study enrolled both sexes, making that criterion not applicable.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographics and anthropometric characteristics are comprehensively reported for human participants. Sex, age, nutritional status, and ethnicity are described. No animal or cell-line work is involved.

Evidence

direct quote[Results, Table 1]

“1154 (49·2%) of 2345 infants and 296 (49·3%) of 600 young children were female.”

direct quote[Results, Table 1]

“Median age at screening (minimum to maximum value) | 33 weeks (18 to 52) | 30 weeks (21 to 52) | 32 weeks (20 to 51)”

PASSReviewer 2· 95% conf

Key biological variables (sex, age, health status, demographics) are well reported.

Evidence

direct quote[Results, paragraph 3 and Table 1]

“1154 (49·2%) of 2345 infants and 296 (49·3%) of 600 young children were female. Between 5·0% and 9·3% of infants and children were at least moderately malnourished (weight for height Z score of <–2 SD).”

PASSReviewer 3· 95% conf

Biological variables, including sex, age, weight-for-height Z-score, anthropometrics, and race/ethnicity, are comprehensively reported for the study participants.

Evidence

direct quote[Results, paragraph 2]

“1154 (49·2%) of 2345 infants and 296 (49·3%) of 600 young children were female.”

direct quote[Table 1]

“Median age at screening (minimum to maximum value) | 33 weeks (18 to 52) | 30 weeks (21 to 52) ... Weight for height Z score <–2 SD | 123 (9·3%) | 14 (5·9%)”

The paper explicitly names the approving ethics bodies: The Gambia Government and MRC joint ethics committee (ref LEO22052), LSHTM Research Ethics Committee, WIRB-Copernicus Group Institutional Review Board, and the Gambian Medicines Control Agency. Written informed consent from parents is stated. Regulatory compliance with the Declaration of Helsinki and Good Clinical Practice is reported. The trial is registered (PACTR202010705577776). All four human-subject sub-criteria are met.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals from multiple named ethics committees and regulatory agencies are stated. Written informed consent, adherence to the Declaration of Helsinki and GCP, and trial registration are reported.

Evidence

direct quote[Methods, Study design and participants]

“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.”

direct quote[Methods, Study design and participants]

“Parents provided written informed consent.”

direct quote[Methods, Study design and participants]

“The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.”

PASSReviewer 2· 95% conf

Ethical approvals and informed consent are comprehensively reported.

Evidence

direct quote[Methods, Study design and participants]

“Parents provided written informed consent.”

direct quote[Methods, Study design and participants]

“The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.”

PASSReviewer 3· 95% conf

Ethical approvals are thoroughly documented with named ethics committees, informed consent, and compliance with recognized regulatory standards.

Evidence

direct quote[Methods, Study design and participants]

“Parents provided written informed consent.”

direct quote[Methods, Study design and participants]

“The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.”

As a human clinical trial of a drug, the applicable sub-criteria are reagents_identified (the investigational product) and software_tools_identified. nOPV2 and bOPV are identified by manufacturer (PT Biofarma, Bandung, Indonesia), formulation (dose/volume, CCID50), and batch/lot numbers (e.g., 2220720). Statistical software and version are not explicitly named in the main text (the checklist notes it as 'not_reported'), but the analysis methods are described. Other bench-science criteria (antibodies, cell lines, mycoplasma, organisms) are not applicable as the study does not use those resources.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (nOPV2 and bOPV) are identified by manufacturer, batch numbers, potency, and dosage. The lab assay is referenced to a WHO standard. Software tools are named, though version numbers are not always given.

Evidence

direct quote[Methods, 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 ) of the nOPV2 strain. The batch numbers for lots 1, 2, and 3 were 2220720, 2220820, and 2220920 respectively.”

direct quote[Methods, Procedures]

“Serotype-specific poliovirus serum neutralising antibodies (SNAs) were measured using the WHO standard microneutralisation assay (WHO EPI Gen 93.9).”

absence[Methods, Statistical analysis]

Statistical software is not explicitly named in the main text.

PASSReviewer 2· 95% conf

Key resources, primarily the investigational vaccines and software, are well identified.

Evidence

direct quote[Methods, Procedures]

absence[Methods, Statistical analysis]

Statistical analysis software is not named in the main text.

PASSReviewer 3· 95% conf

Key resources, including the investigational vaccines and the software used for analysis, are adequately identified with details on manufacturer, lot numbers, and dose specifications.

Evidence

direct quote[Methods, Procedures]

paraphrase[Methods, Statistical analysis]

“The statistical analysis section describes the tests used (e.g., Miettinen and Nurminen CIs, exact Clopper-Pearson CIs, Fisher's exact test) but does not mention the specific statistical software package (e.g., SAS, R, Stata) used.”

Tests named: 95% Miettinen and Nurminen CIs for rate differences, Exact Clopper-Pearson CIs, bootstrap CIs for medians, maximum likelihood survival methods for GMT, Fisher's exact test for safety events. Exact p-values are reported (e.g., p=0·015, p=0·043). Effect sizes and CIs are reported throughout. The software is not explicitly named, but this is a minor inadequacy. Data presentation includes per-group n, exact CIs, and seroprotection/seroconversion rates with CIs—conventions appropriate for a clinical trial. The mathematical plausibility is confirmed: reported percentages are consistent with given Ns (e.g., 1154/2345 = 49.2%, 296/600=49.3%). The seroconversion rates in Table 2 are all consistent with the reported n/N.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedINADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well described: all tests are named, exact p-values and CIs are reported, effect sizes (geometric mean fold rise, rate differences) are shown, and data presentation follows clinical trial conventions (per-group n, CIs, KM-like figures).

Evidence

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Results, paragraph 7]

“...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).”

direct quote[Table 3]

“Post-dose one vs baseline geometric mean fold rise (95% CI) | 10·2 (8·8–11·9)”

PASSReviewer 2· 90% conf

Statistical methods are generally well-reported, with named tests, exact p-values, and effect sizes. Some minor issues are present: software not identified and assumptions not explicitly verified.

Evidence

direct quote[Methods, Statistical analysis]

“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.”

direct quote[Results, paragraph 9]

“fever of 37·5°C or higher was more common in infants following bOPV... than following nOPV2 (105 [15·4%] of 682; 12·8–18·3; p=0·015).”

absence[Methods, Statistical analysis]

Statistical software is not mentioned.

WARNReviewer 3· 90% conf

Statistical tests are named and generally appropriate, but the statistical software is not named, and exact p-values are not always reported (often given as p-values for specific comparisons, but many results are presented with CIs only).

Evidence

direct quote[Methods, Statistical analysis]

“Two-sided 95% Miettinen and Nurminen CIs for the differences in seroconversion rates ... Exact Clopper-Pearson 95% CIs ... Safety event rates were compared using a two-sided Fisher's exact test.”

direct quote[Results, paragraph 13]

“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).”

absence[Methods, Statistical analysis]

Statistical analysis software is not named in the main manuscript.

The data sharing section states that IPD (de-identified) will be available from 3 months to 3 years after publication to researchers who provide a scientific proposal and sign a data access agreement. Supporting documents are available on application to the corresponding author. This meets the threshold for reported_and_adequate for data_availability_statement (managed access with mechanism). However, repository_deposit and accession_numbers are not_applicable for identifiable patient data. Code_sharing is not mentioned; the paper does not state whether custom code was used or whether it is available. Therefore, the applicable criteria are data_availability_statement (adequate) and code_sharing (not_reported). Since not all applicable criteria are adequate, the dimension gets a warn.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present and describes a managed-access route with conditions, which is adequate for individual patient data. However, no code sharing is mentioned, and no public repository deposit with accession numbers is provided.

Evidence

direct quote[Data sharing]

“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.”

absence[Data sharing]

Code sharing is not mentioned.

WARNReviewer 2· 85% conf

A data availability statement is present, but it is vague. For patient-level data, a managed access process is described. No code sharing is mentioned.

Evidence

direct quote[Data sharing section]

“The individual participant data that underlie the results reported in this Article, after de-identification... will be available beginning 3 months and ending 3 years after publication. Supporting clinical documents... will be available immediately following publication on application to the corresponding author.”

absence[Throughout manuscript]

No code sharing statement is present.

WARNReviewer 3· 85% conf

A data availability statement is present, detailing a managed-access mechanism, but the availability is not fully open, and no code was shared. The statement is concrete enough to be adequate, but the lack of code sharing and the time-limited availability leave some gaps.

Evidence

direct quote[Data sharing]

absence[Data sharing and Declaration of interests]

No custom code is mentioned for sharing.

Methods cover randomisation, blinding, procedures, outcomes, and statistical analysis comprehensively. Trial registration is provided. An explicit reporting guideline is not mentioned (no statement that CONSORT or other checklist was followed), which is a minor gap for a clinical trial. All outcomes described in the methods are reported in the results, including negative/null safety findings. Limitations are discussed (no active type-2 control, rare events undetected). Conclusions do not overclaim: they state the data 'support' licensure, not that the vaccine is definitively effective. Funding (Bill & Melinda Gates Foundation) and COI are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Methods are complete and reproducible. The trial is registered (PACTR202010705577776). Limitations are discussed in detail. Conclusions are proportional to the evidence. Funding and COI are stated.

Evidence

direct quote[Abstract / Methods]

“The trial was registered as PACTR202010705577776.”

direct quote[Discussion, last paragraph]

“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. Second, despite the comparison of safety data with bOPV... rare safety events might not have been detected.”

absence[Methods]

No explicit mention of adherence to a reporting guideline (e.g., CONSORT).

PASSReviewer 2· 90% conf

The manuscript is transparent: methods are complete, it is prospectively registered, limitations are discussed, conclusions are proportional, and funding/COI are reported.

Evidence

direct quote[Methods, Study design and participants, last sentence]

“The trial was registered with the Pan-African Clinical Trials Registry (PACTR202010705577776).”

direct quote[Discussion, paragraph beginning 'The trial had several limitations.']

“The trial had several limitations. First, the absence of an active control vaccine for the type 2 immunogenicity and viral excretion data was unavoidable... Second... rare safety events might not have been detected.”

direct quote[Declaration of interests]

“ET works for PT Biofarma who manufacture the novel oral poliovirus vaccine type 2 and the bivalent oral poliovirus vaccine used in this trial. All other authors declare no competing interests.”

WARNReviewer 3· 90% conf

The manuscript is generally transparent, with thorough methods, pre-registration, good discussion of limitations, and proportional conclusions. However, it does not explicitly reference a reporting guideline (CONSORT checklist), and the results for all pre-specified outcomes (especially the secondary outcomes) are not always presented with the same level of detail as primary outcomes.

Evidence

direct quote[Abstract]

“The trial was registered as PACTR202010705577776 and is completed.”

absence[Methods]

A CONSORT or other reporting guideline is not mentioned.

direct quote[Discussion, paragraph 7]

“The trial had several limitations. First, the absence of an active control vaccine for the type 2 immunogenicity and viral excretion data was unavoidable...”

6 copyedit issues flagged: mostly typo, consistency, other.

Checked 29 references: 26 verified — 3 not checked.

Reproducibility

Registration stated in text, but no registry ID was detected. No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor revisions. The most critical fix is to correct the Table 1 age unit (months → weeks) and add a CONSORT checklist statement. Adding the statistical software name and a code sharing statement will strengthen the submission. These are all low-effort changes that address common reviewer requests.

1.
HIGHreporting
Add a statement in the Methods that the trial is reported according to the CONSORT 2010 checklist, and submit the completed checklist as supplementary material.
CONSORT adherence is the expected reporting standard for clinical trials and its absence will likely be flagged by editors.
2.
HIGHcopyedit
Correct the infant age entry in Table 1 for the bOPV group: change '34 months' to '34 weeks' to match the other infant groups and the study eligibility (18 to <52 weeks).
This is a clear inconsistency that could confuse readers and reviewers; the entry is under an 'Infants' column and 34 months would be outside the eligibility criterion.
3.
HIGHstatistics
Name the statistical software package (e.g., SAS version 9.4, R version 4.x) in the Statistical analysis section of the Methods.
Reproducibility requires knowing the exact software environment; journals routinely request this.
4.
MEDIUMdata code
Add a statement about code availability: if custom code was used, share it in a public repository (e.g., GitHub, Zenodo) with a link; if only standard SAS procedures were used, state that explicitly and offer the analysis scripts upon request.
Transparency in analysis code strengthens reproducibility and is increasingly expected by journals.
5.
MEDIUMreporting
In the Discussion, rephrase the sentence beginning 'An absence of previous inactivated poliovirus vaccine immunisation...' for clarity: 'Alternative explanations include an absence of previous IPV immunisation...'.
The copyedit report flagged this sentence as grammatically awkward; a clearer structure improves readability.
6.
MEDIUMstatistics
Briefly note that the statistical test assumptions (e.g., for bootstrap CIs, the assumption of exchangeability; for Fisher's exact test, independence) were considered reasonable given the large sample and randomization, or explain why assumption verification was not required for the chosen methods.
Addresses a gap noted by two reviewers and shows methodological awareness.
7.
LOWreporting
Consider adding exact p-values for all pre-specified comparisons where only CIs are currently reported (e.g., for seroconversion rate differences where CIs are given but not p-values).
Full reporting of exact p-values allows readers to assess significance precisely, though CIs are sufficient for equivalence margins.
8.
LOWcopyedit
In Table 1 footnote, change '* Indicating at least moderate malnutrition.' to 'Indicates at least moderate malnutrition.' for consistency.
Minor style consistency improvement noted in copyedit.

Full text (54,405 chars)Analyzed: Jul 7, 2026

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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.

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DOI

10.1016/S0140-6736(23)02844-1

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