Evidence map›Paper›PMID 37234594›Full record

ArticleVaccine: X2023

A phase-I, open label clinical trial to assess the safety & tolerability of qHPV vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults.

Hitt Sharma, K Anil, Sameer Parekh, Pramod Pujari, Sunil Shewale, Shivani Desai, R L Madhusudhan, Jaya Patel, Anand Eswaraiah, Harish Rao and 2 more

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
0.6field-weighted citation impact, top 29% 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, 3 citations in OpenAlex.

  1. 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 2 institutions in 1 country.

Hitt SharmaSerum Institute of India Pvt. Ltd., Pune, India.
K AnilSyngene International Limited, Bangalore, India.
Sameer ParekhSerum Institute of India Pvt. Ltd., Pune, India.
Pramod PujariSerum Institute of India Pvt. Ltd., Pune, India.
Sunil ShewaleSerum Institute of India Pvt. Ltd., Pune, India.
Shivani DesaiSerum Institute of India Pvt. Ltd., Pune, India.
R L MadhusudhanSyngene International Limited, Bangalore, India.
Jaya PatelSyngene International Limited, Bangalore, India.
Anand EswaraiahSyngene International Limited, Bangalore, India.
Harish RaoSerum Institute of India Pvt. Ltd., Pune, India.
Sunil GairolaSerum Institute of India Pvt. Ltd., Pune, India.
Umesh ShaligramSerum Institute of India Pvt. Ltd., Pune, India.
Serum Institute of India (India) · INSyngene International (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This first in human study was designed as an open label clinical trial to assess safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) quadrivalent HPV (qHPV) vaccine. Methods: A total of 48 healthy male and female (24 each) adult volunteers were administered a 0.5 ml single dose of SIIPL qHPV vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events. Results: 47 subjects completed the study in compliance with protocol. One subject had pain immediately after immunization which was recovered without treatment. None of the participants experienced any other local or systemic solicited AEs and serious AE. Conclusion: qHPV vaccine manufactured by SIIPL was found to be safe and well tolerable in adults. Further clinical development should continue to assess safety and immunogenicity, in the target population following recommended 2 and 3-dose schedule.

Indexed as

AdultPhase IqHPVSafetyVaccine

Identifiers

PMID37234594
PMCPMC10205786
OpenAlexW4378516770

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.