Evidence map›Paper›PMID 37128477›Full record

ArticleVaccine: X2023

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India.

Hitt Sharma, Kiran Marthak, Sameer Parekh, Pramod Pujari, Sunil Shewale, Shivani Desai, Akash Patel, Harish Rao, Sunil Gairola, Umesh Shaligram

Open access · goldAbstract read
In one paragraph

Article in Vaccine: X, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 41% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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 at 2 institutions in 1 country.

Hitt SharmaSerum Institute of India Pvt. Ltd., Pune 411028, India.
Kiran MarthakLambda Therapeutic Research Ltd., Ahmedabad 382481, India.
Sameer ParekhSerum Institute of India Pvt. Ltd., Pune 411028, India.
Pramod PujariSerum Institute of India Pvt. Ltd., Pune 411028, India.
Sunil ShewaleSerum Institute of India Pvt. Ltd., Pune 411028, India.
Shivani DesaiSerum Institute of India Pvt. Ltd., Pune 411028, India.
Akash PatelLambda Therapeutic Research Ltd., Ahmedabad 382481, India.
Harish RaoSerum Institute of India Pvt. Ltd., Pune 411028, India.
Sunil GairolaSerum Institute of India Pvt. Ltd., Pune 411028, India.
Umesh ShaligramSerum Institute of India Pvt. Ltd., Pune 411028, India.
Serum Institute of India (India) · INLambda Therapeutic Research (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Methods: Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes. Results: All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported. Conclusion: SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.

Indexed as

Clinical trialDTaP-IPV+Hib vaccinePhase 1SafetyTolerability

Identifiers

PMID37128477
PMCPMC10148180
OpenAlexW4365457792

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.