Is NCT07348692 recruiting in Simpsonville, SC?

Yes, NCT07348692 is currently recruiting participants at its Simpsonville, SC location. This pneumococcal immunization clinical trial is actively enrolling qualified participants.

How do I join the pneumococcal immunization clinical trial in Simpsonville?

To join this clinical trial in Simpsonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Simpsonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pneumococcal Immunization Clinical Trial in Simpsonville, SC

About This Pneumococcal Immunization Study in Simpsonville

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days

Sponsor: Sanofi

Who Can Participate

Inclusion Criteria

Aged 42 to 89 days on the day of inclusion

Participants who are healthy as determined by medical evaluation including medical history and physical examination

Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable

Exclusion Criteria

Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy

History of microbiologically confirmed Streptococcus pneumoniae infection or disease

Any contraindication to the routine pediatric vaccine being administered in the study

History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy

Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3

Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.

Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.

Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion

Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration.

Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period

Previous vaccination against Streptococcus pneumoniae

Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus

Receipt of more than 1 dose of hepatitis B vaccine

Receipt of immune globulins, blood or blood-derived products since birth

Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Simpsonville?

Yes, this clinical trial (NCT07348692) has an active research site in Simpsonville, SC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pneumococcal Immunization Treatment Options in Simpsonville, SC

If you're searching for pneumococcal immunization treatment options in Simpsonville, SC, this clinical trial (NCT07348692) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Simpsonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pneumococcal immunization specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pneumococcal immunization clinical trials near you to find additional studies recruiting in your area.

Pneumococcal Immunization Clinical Trial in Simpsonville, SC

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