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NCT06824194RECRUITINGIRB Ready

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sponsored by Sanofi

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age.

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 (โ‰ฅ 37 weeks) and with a birth weight โ‰ฅ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight โ‰ฅ 1.5 kg, and in both cases medically stable as assessed by the investigator

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
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 a

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

2320 participants

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Age Range

42 Days - 89 Days

โšง

Gender

ALL

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Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Guntersville

Alabama

Location available
View Guntersville location page
RECRUITING

Oneonta

Alabama

Location available
View Oneonta location page
RECRUITING

Jonesboro

Arkansas

Location available
View Jonesboro location page
RECRUITING

Sherwood

Arkansas

Location available
View Sherwood location page
RECRUITING

Fullerton

California

Location available
View Fullerton location page
RECRUITING

Hawthorne

California

Location available
View Hawthorne location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Madera

California

Location available
View Madera location page

๐Ÿ“ And 64 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Pneumococcal infection Treatment in Guntersville?

Join others in Alabama exploring innovative treatment options through clinical research

Pneumococcal infection Treatment Options in Guntersville, Alabama

If you're searching for Pneumococcal infection treatment in Guntersville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Guntersville, Jonesboro, Concord and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Pneumococcal infection. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 2320 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Pneumococcal infection?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Pneumococcal infection

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Pneumococcal infection Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06824194. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.