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NCT03384589
CIRN Pneumococcal Conjugate Vaccine 1 vs. 2 Dose Priming Study
Phase 2, PHASE3 trial testing PCV13 in Invasive Pneumococcal Disease, Protection Against in 248 participants. Completed in 31 March 2023.
31 March 2023
Quick facts
| Lead sponsor | University of British Columbia |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 248 |
| Start date | 23 August 2018 |
| Primary completion | 31 March 2023 |
| Estimated completion | 31 March 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- PCV13 — full drug profile →
Conditions studied
- Invasive Pneumococcal Disease, Protection Against — all drugs for Invasive Pneumococcal Disease, Protection Against →
- Streptococcus Pneumoniae Infection — all drugs for Streptococcus Pneumoniae Infection →
Sponsor
University of British Columbia
Who can join
Adults 2 Months to 2 Months, any sex, with Invasive Pneumococcal Disease, Protection Against or Streptococcus Pneumoniae Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is assessing if a reduced dosing schedule (1+1) of the 13-valent pneumococcal conjugate vaccine (PCV13) is non-inferior to the currently used schedule used in most of Canada.The vaccine is currently usually given as 3 doses at 2, 4 and 12 months of age. This study aims to find out if it is possible to achieve the same protection using just 2 doses, at 2 and 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03384589
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PCV13
Trials testing the same drug.
- NCT04974294 — PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2) · Phase 4 · unknown
- NCT04525599 — A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 M · Phase 1 · completed
- NCT04384107 — Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033) · Phase 3 · completed
- NCT04275284 — Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children · completed
- NCT06210737 — A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years · Phase 4 · completed
Other University of British Columbia trials
Trials by the same sponsor.
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- NCT07492095 — Leucine Requirements in School-Age Children · NA · not yet recruiting
- NCT07429305 — Combined Tibial Nerve Stimulation and Standing for People With SCI · NA · recruiting
- NCT07519928 — Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for · NA · recruiting
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 NCT03384589 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of British Columbia
- Last refreshed: 4 March 2024
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/NCT03384589.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing