Evidence map›Paper›PMID 28881165›Full record

Trial reportHuman vaccines & immunotherapeutics2017

Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial.

Bhagirath B Solanki, Christine Juergens, Manojkumar B Chopada, Pravin Supe, Vani Sundaraiyer, Natacha Le Dren-Narayanin, Mark W Cutler, William C Gruber, Daniel A Scott, Beate Schmoele-Thoma

Registry-linked trialOpen access · greenAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02034877 (A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

NCT02034877 phase4completednot on this map

A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled1,200ConditionsPrevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnCArms13-valent Pneumococcal conjugate vaccine, Blood sample collection
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Article
  3. IAPSM's Position Paper on Pneumococcal Vaccine (PCV) for Adult Immunization in India.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2024
    Article
  4. Article
  5. Review
  6. A comprehensive review of vaccination in patients with inflammatory bowel diseases:  An Indian perspective.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2020
    Review
  7. Article
  8. The situation of vaccines for the prevention of infections in adults: An opinion paper on the situation in Spain.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019
    Article
  9. Review
  10. Review
  11. 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

10 authors at 5 institutions in 4 countries.

Bhagirath B Solankia B. J. Medical College and Civil Hospital , Gujarat , India.
Christine Juergensb Pfizer Pharma GmbH , Berlin , Germany.
Manojkumar B Chopadac Chopda Medicare and Research Centre Pvt. Ltd. , Maharashtra , India.
Pravin Suped Supe Heart and Diabetes Hospital and Research Centre , Maharashtra , India.
Vani Sundaraiyere inVentiv Health Clinical, LLC , Princeton , NJ , USA.
Natacha Le Dren-Narayaninf Pfizer Ltd , Tadworth , UK.
Mark W Cutlerg Pfizer Inc , Pearl River , NY , USA.
William C Gruberg Pfizer Inc , Pearl River , NY , USA.
Daniel A Scotth Pfizer Inc , Collegeville , PA , USA.
Beate Schmoele-Thomab Pfizer Pharma GmbH , Berlin , Germany.ORCID 0000-0003-4632-357X
Pfizer (United States) · USPfizer (Germany) · DEB.J. Medical College · INDiabetes Care and Research Foundation · INPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Streptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) on natural exposure or revaccination has been shown to protect against community-acquired pneumonia and invasive pneumococcal disease in adults 65 years of age and older. An unconjugated 23-valent pneumococcal polysaccharide vaccine has been available for decades; however, data on protection against pneumonia are inconsistent. For the first time, a multicenter study has been conducted in India to assess the safety and immunogenicity of a single dose of PCV13 in adults aged 50 to 65 years. In this study, PCV13 elicited robust immune responses against all 13 pneumococcal serotypes as reflected by the magnitude of geometric mean fold rises (range, 6.6-102.7) in functional antibody levels from before to 1 month after vaccination. No serious adverse events occurred. These clinical trial findings support the safety and immunogenicity of PCV13 when administered to adults in India and indicate that a single dose of PCV13 has the potential to protect against vaccine-type pneumococcal disease in adults aged 50 to 65 years. ClinicalTrials.gov identifier: NCT02034877.

Indexed as

Immunogenicity, VaccineAgedAntibodies, BacterialDouble-Blind MethodFemaleHumansImmunization, SecondaryImmunoglobulin GImmunologic MemoryIndiaMaleMiddle AgedPneumococcal VaccinesPneumonia, PneumococcalStreptococcus pneumoniaeVaccination13-valent pneumococcal vaccineAntibodies, BacterialImmunoglobulin GPneumococcal VaccinesVaccines, ConjugateadultsimmunogenicityIndiasafetythirteen-valent pneumococcal conjugate vaccine

Identifiers

PMID28881165
PMCPMC5612423
OpenAlexW2752903334

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.