Evidence map›Paper›PMID 25424809›Full record

Trial reportHuman vaccines & immunotherapeutics2014

A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I).

Roman Prymula, Susanna Esposito, Gian Vincenzo Zuccotti, Fang Xie, Daniela Toneatto, Igor Kohl, Peter M Dull

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
9.6field-weighted citation impact, top 1% 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 97 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Review
  12. 4CMenB journey to the 10-year anniversary and beyond.Human vaccines & immunotherapeutics · 2024
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Product review on the IMD serogroup B vaccine Bexsero®.Human vaccines & immunotherapeutics · 2022
    Article
  18. Article
  19. Review
  20. 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

7 authors at 5 institutions in 5 countries.

Roman Prymulaa University Hospital Hradec Kralove; Hradec Kralove, Czech Republic.
Susanna Esposito
Gian Vincenzo Zuccotti
Fang Xie
Daniela Toneatto
Igor Kohl
Peter M Dull
Novartis (Germany) · DENovartis (United States) · USIntensive Care Society · GBUniversity Hospital Hradec Králové · CZUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability, we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and 12 months of age concomitantly with routine infant vaccines: DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol; a third group received MenC vaccine. Immune responses to 4CMenB were not decreased by the use of paracetamol prophylaxis and there were no clinically relevant effects on immune responses to routine vaccines. Occurrence of fever was higher in infants co-administered with 4CMenB compared with those given MenC vaccine, but was significantly decreased by prophylactic paracetamol, as were other solicited reactions to vaccination, both local and systemic. Co-administration of 4CMenB had an acceptable tolerability profile, with no withdrawals due to vaccination-related adverse events. Inclusion of 4CMenB in routine infant immunization schedules will be a major advance in the control of meningococcal disease, and our study indicates that by using paracetamol prophylaxis, post-vaccination reactions are reduced without clinically relevant negative consequences on vaccine immunogenicity.

Indexed as

AcetaminophenAntipyreticsDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantMaleMeningococcal VaccinesNeisseria meningitidis, Serogroup BProspective Studies4CMenB vaccineAcetaminophenAntipyreticsMeningococcal Vaccinesantipyreticsinfantsmeningococcalserogroup Bvaccination

Identifiers

PMID25424809
PMCPMC4186040
OpenAlexW1943307706

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.