Status:
COMPLETED
Open Randomized Trial Evaluating Four Anti-pneumococcal Vaccine Strategies With Fractionated Doses of Non Conjugate Polysaccharide Vaccine to Prevent Hyporesponse in Healthy Volunteers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Individuals (males and females) of age ≥ 18 to ≤ 49 years old;
- Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination clinical judgement of the investigator.
- Women of childbearing potential must have a negative pregnancy test and an effective contraception during the first 13 months of the study;
- Individuals able to participate and to follow up during the 36 months of the study
- Individuals covered by social security regimen
Exclusion
- Individuals with behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- Individuals with indication to anti-pneumococcal vaccination at the time of enrolment according to the French vaccination schedule (vaccinal calender BEHn°14-15/2013);
- Individuals with history of pneumococcal vaccination;
- Individuals with history of suspected or low documented invasive pneumococcal infection within the year before enrolment;
- Individuals who have received any another vaccines within 4 weeks prior to enrolment or who are planning to receive any vaccine within the first 13 months of the study; (except Annual influenza vaccination which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up)
- Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks before enrolment
- Individuals who have received systemic antibiotic within 7 days before inclusion (except 14 days concerning azithromycine), regardless the duration or dosage
- Individuals with body temperature ≥ 38.0 degrees Celsius within 3 days of study vaccination.
- Individuals with personal or familial history of any illness that, in the opinion of the investigator, might pose additional risk to the subjects due to participation in the study.
- Individual with personal or familial (first degree relatives) history of an auto-immune disorder, or any other known or suspected impairment /alteration of the immune system or under immunosuppressive therapy, including use of systemic corticosteroids (i.e. prednisone, or equivalent) ≥ 10mg/day more than 6 days within the previous 28 days or within 3 days regardless dosage and duration, or in chemotherapy treatment or other immunosuppressive or immunomodulating therapy within the past 168 days (6 months). Topical or inhaled uses of steroid including intranasal are allowed.
- Individuals with thrombocytopenia or coagulation disorder contra-indicating intramuscularly injections; coagulation disorder contra-indicating intramuscularly injections;
- Individuals with evolutionary cancer, cirrhosis, known infection to HIV/ HBV/ HCV or any serious chronic or progressive disease according to the judgment of the investigator
- Individuals with acute respiratory tract infection within the month before enrolment;
- Individuals with history of known allergies/hypersensitivity to any component of both study vaccines;
- Women, who are pregnant or breast-feeding
- Individuals under a measure of legal protection or unable to consent.
- Individuals participating in any clinical trial 28 days prior to first study visit until the M24 visit of the study (+ the day of M36 visit).
Key Trial Info
Start Date :
December 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02279589
Start Date
December 4 2014
End Date
September 6 2018
Last Update
August 3 2021
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