Evidence map›Paper›PMID 30518331›Full record

Trial reportBMC infectious diseases2018

Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults.

Joon Young Song, Hee Jin Cheong, Ji Yun Noh, Min Joo Choi, Jin Gu Yoon, Saem Na Lee, Seong Hui Kang, Eun Joo Jeong, Yu Mi Jo, Woo Joo Kim

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03552445 (Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03552445 phase4completednot on this map

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults

TypeinterventionalSponsorKorea University Guro HospitalRan2013 to 2018Enrolled462ConditionsTetanus, Diphtheria, Pneumococcal InfectionsArmsTetanus-diphtheria (Td) and PCV13, PCV13 alone, Td alone
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. 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

10 authors.

Joon Young SongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Hee Jin CheongDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. heejinmd@korea.ac.kr.
Ji Yun NohDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Min Joo ChoiDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Jin Gu YoonDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Saem Na LeeDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Seong Hui KangDivision of Infectious Diseases, Department of Internal Medicine, Konyang University Hospital, Daejeon, Korea.
Eun Joo JeongDepartment of Internal Medicine, Hallym University School of Medicine, Seoul, Korea.
Yu Mi JoDepartment of Internal Medicine, Gachon University of Gil Medical Center, Incheon, Korea.
Woo Joo KimDivision of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.

Funding

Korea University Q1604581
6 · The paper itself

Abstract

backgroundWhen two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.

methodsSubjects aged ≥50 years were randomized 1:1:1 to receive tetanus-diphtheria (Td) + 13-valent pneumococcal conjugate vaccine (PCV13; Group 1), PCV13 alone (Group 2), or Td alone (Group 3). After single or concomitant vaccination, enzyme-linked immunosorbent assay and opsonophagocytic assay (OPA) were performed to compare immunogenicity for Td and PCV13, respectively.

resultsA total of 448 subjects were available for the assessment. After concomitant administration, the non-inferiority criteria of geometric mean titer (GMT) ratios were met for tetanus, diphtheria, and all four pneumococcal serotypes (1, 5, 18C, and 19A). However, subjects in Group 3 (Td alone) were more likely to have a high IgG anti-tetanus antibody titer (≥ 0.5 U/mL) than those in Group 1 (Td + PCV13) (p <  0.01). As for the pneumococcal serotype 1, the OPA GMT was significantly higher in Group 1 (PCV13 + Td) compared to Group 2 (PCV13 alone) (p = 0.02). No serious adverse event occurred.

conclusionsConcomitant Td and PCV13 administration induced sufficient immunity without significant interference and showed good safety profiles. TRIALS REGISTRATION: NCT03552445 registered at http://www.clinicaltrials.gov on June 11, 2018 (retrospectively registered).

Indexed as

Diphtheria-Tetanus VaccineImmunogenicity, VaccinePneumococcal VaccinesAdultAgedAged, 80 and overDiphtheriaFemaleHumansMaleMiddle AgedPneumococcal InfectionsRetrospective StudiesStreptococcus pneumoniaeTetanusVaccinationDiphtheria-Tetanus VaccinePneumococcal VaccinesVaccines, ConjugateDiphtheriaImmunogenicityPneumococcal conjugate vaccineTetanus

Identifiers

PMID30518331
PMCPMC6282243

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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.