Evidence map›Paper›PMID 24249544›Full record

Trial reportPediatric blood & cancer2014

Safety of high dose trivalent inactivated influenza vaccine in pediatric patients with acute lymphoblastic leukemia.

Meghann McManus, Haydar Frangoul, Jonathan A McCullers, Li Wang, Alice O'Shea, Natasha Halasa

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Pediatric blood & cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
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.

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

15 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Seasonal influenza vaccine in immunocompromised persons.Human vaccines & immunotherapeutics · 2018
    Review
  13. Influenza vaccines: Evaluation of the safety profile.Human vaccines & immunotherapeutics · 2018
    Review
  14. Article
  15. Review
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

6 authors at 3 institutions in 1 country.

Meghann McManusDepartment of Pediatrics, Division of Hematology/BMT, University of Utah School of Medicine/Primary Children's Hospital, Salt Lake City, Utah.
Haydar Frangoul
Jonathan A McCullers
Li Wang
Alice O'Shea
Natasha Halasa
Vanderbilt University · USSt. Jude Children's Research Hospital · USUniversity of Utah · US

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)KL2TR000446 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$2.8M
NCATS NIH HHS KL2 TR000446NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1TR000445
6 · The paper itself

Abstract

backgroundAlthough children with acute lymphoblastic leukemia (ALL) mount immune responses after vaccination with the trivalent influenza vaccine (TIV), these responses are lower compared to controls. Recently, a high dose (HD) TIV was found to increase the level of antibody response in elderly patients compared to the standard dose (SD) TIV. We hypothesized that the HD TIV would be well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects with ALL. PROCEDURE: This was a randomized, double-blind, phase I safety trial comparing the HD to the SD TIV in children with ALL. Our secondary objective was immunogenicity. Subjects were randomized 2:1 to receive either the HD (60 µg) or the SD (15 µg) TIV. Local and systemic reactions were solicited, hemagglutinin inhibition titers to influenza virus antigens were measured, and monitoring labs were collected prior to and/or after each vaccination.

resultsFifty subjects were enrolled (34 HD, 16 SD). Mean age was 8.5 years; 63% were male, and 80% were in maintenance therapy. There were no significant differences reported in local or systemic symptoms. No severe adverse events were attributed to vaccination. No significant differences between the HD and SD TIV groups were noted for immune responses.

conclusionsNo differences were noted between the HD and SD TIV groups for solicited systemic and local reactions. Since this study was not powered for immunogenicity, a phase II trial is needed to determine the immunogenicity of HD versus SD TIV in the pediatric ALL population.

Indexed as

AdolescentAntibodies, ViralChildChild, PreschoolDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHemagglutination Inhibition TestsHumansInfluenza A virusInfluenza, HumanInfluenza VaccinesInjections, IntramuscularMalePrecursor Cell Lymphoblastic Leukemia-LymphomaAntibodies, ViralInfluenza VaccinesVaccines, Inactivatedchildreninfluenzaleukemiatrivalent inactivated influenza vaccine

Identifiers

PMID24249544
PMCPMC4310469
OpenAlexW1959377013

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.