Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.

  • STATUS
    Recruiting
  • End date
    Jan 19, 2022
  • participants needed
    750
  • sponsor
    Sanofi
Updated on 19 July 2021

Summary

Primary Objective:

  • To assess the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination
  • To assess the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23

Description

The duration of each participant's participation will be approximately 6 months.

Details
Condition Pneumoccocal Immunisation
Treatment Pneumococcal Vaccine Polyvalent, Pneumococcal Conjugate Vaccine - formulation 1, Pneumococcal Conjugate Vaccine - formulation 2, Pneumococcal Conjugate Vaccine - formulation 3, Pneumococcal 13 - valent conjugate vaccine
Clinical Study IdentifierNCT04583618
SponsorSanofi
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 50 to 84 years on the day of inclusion
Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria

Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile
Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV)
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of S. pneumoniae infection or disease, confirmed either serologically, or microbiologically
History of Guillain-Barr syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine
Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine < 10 years ago
Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion
At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity)
Current alcohol abuse or drug addiction
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 [COVID-19])
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has subsided
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note