Evidence map›Paper›PMID 26075317›Full record

Trial reportHuman vaccines & immunotherapeutics2015

Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial.

Noris Pavia-Ruz, Katia Abarca, Alejandro Lepetic, Maria Yolanda Cervantes-Apolinar, Karin Hardt, Girish Jayadeva, Sherine Kuriyakose, Htay Htay Han, Manuel de la O

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 98% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

9 authors at 6 institutions in 8 countries.

Noris Pavia-Ruza Universidad Nacional Autónoma de México; , México City , Mexico.
Katia Abarca
Alejandro Lepetic
Maria Yolanda Cervantes-Apolinar
Karin Hardt
Girish Jayadeva
Sherine Kuriyakose
Htay Htay Han
Manuel de la O
GlaxoSmithKline (United States) · USGlaxoSmithKline (India) · INGlaxoSmithKline (Switzerland) · CHMedicina · PLUniversidad Autónoma de Nuevo León · MXUniversidad Nacional Autónoma de México · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.

Indexed as

SyringesAdolescentAntibodiesAntigensChildDiphtheria-Tetanus-acellular Pertussis VaccinesFemaleHumansImmunization, SecondaryMaleSingle-Blind MethodTreatment OutcomeVaccinationAntibodiesAntigensDiphtheria-Tetanus-acellular Pertussis VaccinesANCOVA, analysis of co-varianceATP, according to protocolboosterCI, confidence intervaldiphtheriadTpa, reduced-antigen-content diphtheria tetanus and acellular pertussis vaccineEl.U, Elisa unitsFHA, filamentous hemagglutininGI, gastrointestinalGMC, geometric mean concentrationIU, international unitsLL, lower limitpertussisPRN, pertactinPT, pertussis toxinSAE, serious adverse eventsyringe presentationtetanusTVC, total vaccinated cohortUL, upper limit

Identifiers

PMID26075317
PMCPMC4514261
OpenAlexW1488279975

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LicenceCC BY-NC
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Registered trials

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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.