Evidence map›Paper›PMID 37480110›Full record

ArticleTrials2023

Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) - a protocol for two parallel, open-label, randomised controlled trials.

Sarah Kelly, Xinxue Liu, Katherine Theiss-Nyland, Merryn Voysey, Sarah Murphy, Grace Li, Mary Nyantaro, Meeru Gurung, Sudha Basnet, Bhishma Pokhrel and 26 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 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 40% 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

36 authors at 7 institutions in 3 countries.

Sarah Kelly *Oxford Vaccine Group, University of Oxford, Oxford, UK.
Xinxue Liu *Oxford Vaccine Group, University of Oxford, Oxford, UK.
Katherine Theiss-Nyland *Oxford Vaccine Group, University of Oxford, Oxford, UK.
Merryn Voysey *Oxford Vaccine Group, University of Oxford, Oxford, UK.
Sarah MurphyOxford Vaccine Group, University of Oxford, Oxford, UK.
Grace LiOxford Vaccine Group, University of Oxford, Oxford, UK. grace.li@paediatrics.ox.ac.uk.ORCID http://orcid.org/0000-0002-6661-0421
Mary NyantaroMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Meeru GurungPatan Academy of Health Sciences, Lalitpur, Nepal.
Sudha BasnetDepartment of Paediatrics, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
Bhishma PokhrelPatan Academy of Health Sciences, Lalitpur, Nepal.
Sanjeev M BijukchhePatan Academy of Health Sciences, Lalitpur, Nepal.
Agnes EordoghOxford Vaccine Group, University of Oxford, Oxford, UK.
Ben GombeMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Ayoub KakandeMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Simon KerridgeOxford Vaccine Group, University of Oxford, Oxford, UK.
Geofrey KimbugweMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Sylvia KusemererwaMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Lawrence LubyayiMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Henry LuzzeMinistry of Health, Kampala, Uganda.
Olga MazurOxford Vaccine Group, University of Oxford, Oxford, UK.
Yama F MujadidiOxford Vaccine Group, University of Oxford, Oxford, UK.
Shamim NabukenyaMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Walter-Rodney NagumoOxford Vaccine Group, University of Oxford, Oxford, UK.
Tryphena NareebaMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Rabiullah NoristaniOxford Vaccine Group, University of Oxford, Oxford, UK.
Peter O'ReillyOxford Vaccine Group, University of Oxford, Oxford, UK.
Andrew RobertsOxford Vaccine Group, University of Oxford, Oxford, UK.
Ganesh ShahPatan Academy of Health Sciences, Lalitpur, Nepal.
Sonu ShresthaOxford Vaccine Group, University of Oxford, Oxford, UK.
Laxman P ShresthaDepartment of Paediatrics, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
Surya B ThapaDepartment of Paediatrics, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
Freddie M KibengoMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Arun K SharmaDepartment of Paediatrics, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
Alison ElliottMRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda.
Shrijana ShresthaPatan Academy of Health Sciences, Lalitpur, Nepal.
Andrew J PollardOxford Vaccine Group, University of Oxford, Oxford, UK.
University of Oxford · GBUganda Virus Research Institute · UGPatan Academy of Health Sciences · NPTribhuvan University · NPMinistry of Health · UGOxford BioMedica (United Kingdom) · GBOxford Research Group · GB

Funding

Medical Research Council MC_UU_00027/5Medical Research Council MC_UU_00033/1Medical Research Council MR/K019708/1
6 · The paper itself

Abstract

backgroundUniversal immunisation is the cornerstone of preventive medicine for children, The World Health Organisation (WHO) recommends diphtheria-tetanus-pertussis (DTP) vaccine administered at 6, 10 and 14 weeks of age as part of routine immunisation. However, globally, more than 17 unique DTP-containing vaccine schedules are in use. New vaccines for other diseases continue to be introduced into the infant immunisation schedule, resulting in an increasingly crowded schedule. The OptImms trial will assess whether antibody titres against pertussis and other antigens in childhood can be maintained whilst adjusting the current Expanded Programme on Immunisation (EPI) schedule to provide space for the introduction of new vaccines.

methodsThe OptImms studies are two randomised, five-arm, non-inferiority clinical trials in Nepal and Uganda. Infants aged 6 weeks will be randomised to one of five primary vaccination schedules based on age at first DTwP-vaccination (6 versus 8 weeks of age), number of doses in the DTwP priming series (two versus three), and spacing of priming series vaccinations (4 versus 8 weeks). Additionally, participants will be randomised to receive their DTwP booster at 9 or 12 months of age. A further sub-study will compare the co-administration of typhoid vaccine with other routine vaccines at one year of age. The primary outcome is anti-pertussis toxin IgG antibodies measured at the time of the booster dose. Secondary outcomes include antibodies against other vaccine antigens in the primary schedule and their safety. DISCUSSION: These data will provide key data to inform policy decisions on streamlining vaccination schedules in childhood. TRIAL REGISTRATIONS: ISRCTN12240140 (Nepa1, 7

Indexed as

Diphtheria-Tetanus-Pertussis VaccineVaccinationChildEquivalence Trials as TopicHumansImmunization ScheduleInfantNepalPolicyRandomized Controlled Trials as TopicDiphtheria-Tetanus-Pertussis VaccineEPIGlobal child healthImmunisationPertussisVaccination schedules

Identifiers

PMID37480110
PMCPMC10360224
OpenAlexW4385064287

What OpenQuestion holds

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LicenceCC BY
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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.