Evidence map›Paper›PMID 29659924›Full record

Trial reportThe Journal of infectious diseases2018

Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants.

Fadima C Haidara, Milagritos D Tapia, Samba O Sow, Moussa Doumbia, Flanon Coulibaly, Fatoumata Diallo, Awa Traoré, Mamoudou Kodio, Corey L Kelly, Meagan Fitzpatrick and 3 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02286895 (An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02286895 phase4completednot on this map

An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

TypeinterventionalSponsorPATHRan2014 to 2015Enrolled600ConditionsDiarrhea RotavirusArmspentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV), meningitis conjugate vaccine (PsA-TT-5μg)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021
    Trial
  8. Trial
  9. Review
  10. Observational
  11. Evaluation of ROTARIXVaccines · 2023
    Article
  12. Article
  13. Plasma Rotavirus-specific IgA and Risk of Rotavirus Vaccine Failure in Infants in Malawi.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Global Review of the Age Distribution of Rotavirus Disease in Children Aged <5 Years Before the Introduction of Rotavirus Vaccination.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 2 countries.

Fadima C HaidaraCentre pour le Développement des Vaccins-Mali, Bamako.
Milagritos D TapiaCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Samba O SowCentre pour le Développement des Vaccins-Mali, Bamako.
Moussa DoumbiaCentre pour le Développement des Vaccins-Mali, Bamako.
Flanon CoulibalyCentre pour le Développement des Vaccins-Mali, Bamako.
Fatoumata DialloCentre pour le Développement des Vaccins-Mali, Bamako.
Awa TraoréCentre pour le Développement des Vaccins-Mali, Bamako.
Mamoudou KodioCentre pour le Développement des Vaccins-Mali, Bamako.
Corey L KellyPATH, Seattle, Washington.
Meagan FitzpatrickCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Karen KotloffCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
John C VictorPATH, Seattle, Washington.
Kathleen NeuzilCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Centre Pour le Développement des Vaccins-Mali · MLUniversity of Maryland, Baltimore · USProgram for Appropriate Technology in Health · US

Funding

FELLOWSHIP TRAINING PROGRAM IN VACCINOLOGYT32AI007524 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Marcelo B. Sztein · 1997 to 2026
$6.4M
NIAID NIH HHS T32 AI007524
6 · The paper itself

Abstract

Background: Rotavirus vaccines given to infants are safe and efficacious. A booster dose of rotavirus vaccine could extend protection into the second year of life in low-resource countries. Methods: We conducted an open-label, individual-randomized trial in Bamako, Mali. We assigned 600 infants aged 9-11 months to receive measles vaccine (MV), yellow fever vaccine (YFV), and meningococcal A conjugate vaccine (MenAV) with or without pentavalent rotavirus vaccine (PRV). We assessed the noninferiority (defined as a difference of ≤10%) of seroconversion and seroresponse rates to MV, YFV, and MenAV. We compared the seroresponse to PRV. Results: Seroconversion to MV occurred in 255 of 261 PRV recipients (97.7%) and 246 of 252 control infants (97.6%; difference, 0.1% [95% confidence interval {CI}, -4.0%-4.2%]). Seroresponse to YFV occurred in 48.1% of PRV recipients (141 of 293), compared with 52.2% of controls (153 of 293; difference, -4.1% [95% CI, -12.2%-4.0%]). A 4-fold rise in meningococcus A bactericidal titer was observed in 273 of 292 PRV recipients (93.5%) and 276 of 293 controls (94.2%; difference, -0.7% [95% CI, -5.2%-3.8%]). Rises in geometric mean concentrations of immunoglobulin A and immunoglobulin G antibodies to rotavirus were higher among PRV recipients (118 [95% CI, 91-154] and 364 [95% CI, 294-450], respectively), compared with controls (68 [95% CI, 50-92] and 153 [95% CI, 114-207], respectively). Conclusions: PRV did not interfere with MV and MenAV; this study could not rule out interference with YFV. PRV increased serum rotavirus antibody levels. Clinical Trials Registration: NCT02286895.

Indexed as

Immunization, SecondaryAntibodies, BacterialAntibodies, ViralDrug InteractionsFemaleHumansImmunoglobulin AImmunoglobulin GInfantMaleMaliMeasles VaccineMeningococcal VaccinesRotavirus InfectionsRotavirus VaccinesVaccines, AttenuatedAntibodies, BacterialAntibodies, ViralImmunoglobulin AImmunoglobulin GMeasles VaccineMeningococcal VaccinesRotaTeqRotavirus VaccinesVaccines, AttenuatedVaccines, ConjugateYellow Fever Vaccine

Identifiers

PMID29659924
PMCPMC6047426
OpenAlexW2798152895

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.