Evidence map›Paper›PMID 29027148›Full record

Trial reportDrug safety2018

Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.

Prashant V Nigwekar, Anuj Kumar, Vikram V Padbidri, Amlan Choudhury, Amol B Chaudhari, Prasad S Kulkarni

Abstract readClinical Trial, Phase IV
PubMed Publisher
In one paragraph

Trial report in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.5field-weighted citation impact, top 31% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
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  4. Article
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  8. Noninvasive vaccination against infectious diseases.Human vaccines & immunotherapeutics · 2018
    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 4 institutions in 1 country.

Prashant V NigwekarPravara Institute of Medical Sciences, Loni, India.
Anuj KumarPravara Institute of Medical Sciences, Loni, India.
Vikram V PadbidriJehangir Hospital, Pune, India.
Amlan ChoudhuryKPC Medical College, Kolkata, India.
Amol B ChaudhariSerum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India. amol.chaudhari@seruminstitute.com.
Prasad S KulkarniSerum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India.
Pravara Institute of Medical Sciences · INSerum Institute of India (India) · INJehangir Hospital · INKPC Medical College and Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

aimA trivalent live attenuated influenza vaccine (Nasovac-S METHODOLOGY: This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries.

resultsAmong 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18-49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine.

conclusionsThe data from the study adds to the existing safety database of Nasovac-S. REGISTRY: Clinical Trials Registry of India (CTRI/2015/08/006074).

Indexed as

Administration, IntranasalAdolescentAdultChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleHealthy VolunteersHumansIndiaInfluenza, HumanInfluenza VaccinesMaleMiddle AgedRussiaSeasonsInfluenza VaccinesVaccines, AttenuatedVaccines, Inactivated

Identifiers

PMID29027148
OpenAlexW2763542074

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.