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NCT06736041RECRUITINGIRB Ready

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Sponsored by Sanofi Pasteur, a Sanofi Company

Quick Self-Assessment

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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 measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 89 days).

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 vaccines being administered in the study
History of seizure or significant stable or progressive neurological disorders suc

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

1630 participants

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Age Range

42 Days - 89 Days

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Gender

ALL

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Sponsor

Sanofi Pasteur, a Sanofi Company

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Glendale

Arizona

Location available
View Glendale location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Fayetteville

Arkansas

Location available
View Fayetteville location page
RECRUITING

Fountain Valley

California

Location available
View Fountain Valley location page
RECRUITING

Huntington Park

California

Location available
View Huntington Park location page
RECRUITING

Huntington Park

California

Location available
View Huntington Park location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Ventura

California

Location available
View Ventura location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page

๐Ÿ“ And 48 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 Disease Treatment in Tucson?

Join others in Arizona exploring innovative treatment options through clinical research

Pneumococcal Disease Treatment Options in Tucson, Arizona

If you're searching for Pneumococcal Disease treatment in Tucson, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tucson, Fayetteville, Huntington Park 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 Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 1630 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Pneumococcal Disease?

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 Disease

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 Disease 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: NCT06736041. 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.