Evidence map›Paper›PMID 30396317›Full record

Trial reportHuman vaccines & immunotherapeutics2019

Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults.

Joon Young Song, Jacob Lee, Heung Jeong Woo, Seong-Heon Wie, Jin Soo Lee, Shin Woo Kim, Tae Hyong Kim, Sook-In Jung, Ji Yun Noh, Won Suk Choi and 2 more

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

Trial report in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 36% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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

12 authors at 6 institutions in 1 country.

Joon Young Songa Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.ORCID 0000-0002-0148-7194
Jacob Leeb Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital , Hallym University College of Medicine , Seoul , Korea.
Heung Jeong Wooc Division of Infectious Diseases, Department of Internal Medicine, Dongtan Sacred Heart Hospital , Hallym University College of Medicine , Hwasung , Korea.
Seong-Heon Wied Division of Infectious Diseases, Department of Internal Medicine , Catholic University Medical College, St. Vincent's Hospital , Suwon , Korea.
Jin Soo Leee Division of Infectious Diseases, Department of Internal Medicine , Inha University College of Medicine , Incheon , Korea.
Shin Woo Kimf Division of Infectious Diseases, Department of Internal Medicine , Kyungpook National University School of Medicine , Daegu , Korea.
Tae Hyong Kimg Division of Infectious Diseases, Department of Internal Medicine , Soon Chun Hyang University Hospital, Soon Chun Hyang University College of Medicine , Seoul , Korea.
Sook-In Jungh Division of Infectious Diseases, Department of Internal Medicine, Chonnam National University Medical School , Chonnam National University Hospital , Gwangju , Korea.
Ji Yun Noha Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.
Won Suk Choia Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.
Hee Jin Cheonga Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.
Woo Joo Kima Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.
Korea University · KRInha University · KRChonnam National University Hospital · KRHallym University Dongtan Sacred Heart Hospital · KRKyungpook National University · KRThe Catholic University of Korea St. Vincent's Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

Indexed as

Immunogenicity, VaccineAdultAntibodies, ViralAntigens, ViralDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsEggsFemaleHumansInfluenza A virusInfluenza B virusInfluenza, HumanInfluenza VaccinesMaleMiddle AgedSeroconversionAntibodies, ViralAntigens, ViralInfluenza VaccinesVaccines, InactivatedInactivated quadrivalent influenza vaccineInfluenza Bvictoria lineageyamagata lineage

Identifiers

PMID30396317
PMCPMC6605850
OpenAlexW2899528980

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.