NCT02279589 (HYPOPNEUMO) is a Phase 2 clinical trial of Pneumo 23® 0,5 in Pneumococcal Infection, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT02279589?

NCT02279589 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT02279589?

Interventions in NCT02279589: Pneumo 23® 0,5, Pneumo 23® 0,1, Prevenar13® 0,5.

What condition does NCT02279589 study?

NCT02279589 studies Pneumococcal Infection.

Is NCT02279589 still recruiting?

NCT02279589 is currently completed. Last updated 31 July 2021.

Last reviewed 2021-07-31 · How we verify

NCT02279589: HYPOPNEUMO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open Randomized Trial Evaluating Four Anti-pneumococcal Vaccine Strategies With Fractionated Doses of Non Conjugate Polysaccharide Vaccine to Prevent Hyporesponse in Healthy Volunteers

Completed Phase 2 Last updated 31 July 2021

What this trial tests

Phase 2 trial testing Pneumo 23® 0,5 in Pneumococcal Infection in 60 participants. Completed in 6 September 2018.

Timeline

4 December 2014

Primary endpoint
1 June 2016

6 September 2018

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	4 December 2014
Primary completion	1 June 2016
Estimated completion	6 September 2018

Drugs / interventions tested

Pneumo 23® 0,5 — full drug profile →
Pneumo 23® 0,1 — full drug profile →
Prevenar13® 0,5 — full drug profile →

Conditions studied

Pneumococcal Infection — all drugs for Pneumococcal Infection →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 49, any sex, with Pneumococcal Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Geometric mean antibody titers measured by OpsonoPhagocytose Assay (OPA) at 13 months
Time frame: 13 months
The primary end point is the geometric mean antibody titers measured by OPA (OpsonoPhagocytose Assay) for 9 common serotypes to both PPV23 and PCV13 (3, 6B, 7F, 9V, 14,18C, 19A, 19F, 23F), at 1 month after the third dose of vaccine (at M13)

Sponsor's own description

Immune response analysis after the combination of PCV13 and PPV23 will lead to evaluate if a prime with PCV13 help to obtain a good response to repeated dose of PPV23.The hyporesponsiveness following the unconjugated vaccine is associated with high polysaccharide antigen concentration. Several issues limit the development and recommendation of anti-pneumococcal vaccine in adult's patients at risk. Reduced doses of unconjugated polysaccharide antigens would bypass the hyporesponsiveness and maintain the expanded coverage serotype. A better knowledge of immune response following the combination of two vaccines in adults is essential. In addition, adults are required to be exposed to repeated doses of polysaccharide antigens by vaccine or by natural exposure, it is important to determine the extend and duration of any hyporesponsiveness. The main objective is to evaluate if non conjugate polysaccharidique fractionated doses administered after a conjugate vaccine help to avoid hyporesponse in a schedule with repeated injections of pneumococcal polysaccharidique vaccine

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:

Other recruiting trials for Pneumococcal Infection

Currently open trials in the same condition.

NCT07300267 — A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002) · Phase 1 · recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02279589 (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 Assistance Publique - Hôpitaux de Paris
Last refreshed: 31 July 2021

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/NCT02279589.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing