Evidence map›Paper›PMID 15855455›Full record

ArticleAmerican journal of public health2005

Evaluating the safety of new vaccines: summary of a workshop.

Susan S Ellenberg, Mary A Foulkes, Karen Midthun, Karen L Goldenthal

Abstract readEvaluation Study
In one paragraph

Article in American journal of public health, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010-2013.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Article
  9. Article
  10. Article
  11. Article
  12. What should an ideal vaccine postlicensure safety system be?American journal of public health · 2009
    Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Susan S EllenbergCenter for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA. sellenbe@cceb.upenn.edu <sellenbe@cceb.upenn.edu>
Mary A Foulkes
Karen Midthun
Karen L Goldenthal

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled "Evaluation of New Vaccines: How Much Safety Data?" was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions.

Indexed as

Public HealthVaccinesChildClinical Trials as TopicCongresses as TopicHumansInfantMulticenter Studies as TopicUnited StatesUnited States Public Health ServiceVaccines

Identifiers

PMID15855455
PMCPMC1449258

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.