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NCT03762824: IPS-BOOSTER
Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease
Phase 4 trial testing 13-valent pneumococcal conjugate vaccine in Rheumatoid Arthritis in 300 participants. Completed in 21 December 2020.
3 September 2018
Quick facts
| Lead sponsor | Region Skane |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 14 June 2016 |
| Primary completion | 3 September 2018 |
| Estimated completion | 21 December 2020 |
Drugs / interventions tested
- 13-valent pneumococcal conjugate vaccine (13-valent-pneumococcal-conjugate-vaccine) — full drug profile →
- 23-valent pneumococcal polysaccharide vaccine — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Systemic Lupus — all drugs for Systemic Lupus →
- Sjögren Syndrome — all drugs for Sjögren Syndrome →
- Systemic Vasculitis — all drugs for Systemic Vasculitis →
Sponsor
Region Skane — full company profile →
Who can join
18 and older, any sex, with Rheumatoid Arthritis or Systemic Lupus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination and efficacy in preventing invasive pneumococcal disease. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prime-boost vaccination strategy enhances immunogenicity compared to single pneumococcal conjugate vaccination in patients receiving conventional DMARDs, to some extent in abatacept but not in rituximab-treated patients.
Nived P, Jönsson G, Settergren B, Einarsson J, et al · · 2020 · cited 14× · PMID 32087733 · DOI 10.1186/s13075-020-2124-3
Verify or expand the search:
- PubMed search for NCT03762824
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05408429 — Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13 · Phase 3 · completed
- NCT05084508 — A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a · Phase 2 · completed
- NCT04530838 — 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants · Phase 3 · completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
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- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Region Skane trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03762824 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Region Skane
- Last refreshed: 29 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03762824.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing