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NCT06720038RECRUITINGIRB Ready

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

Sponsored by Vaxcyte, Inc.

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

The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.

Who Can Participate

Inclusion Criteria

Healthy male or female infant โ‰ฅ42 days to โ‰ค89 days. 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for โ‰ฅ72 hours with an tympanic or rectal temperature \<38.0ยฐC (\<100.4ยฐF) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for โ‰ฅ72 hours. 4. Able to attend all scheduled visits and comply with the study procedures. 5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent. 6. Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.

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

900 participants

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Age Range

42 Days - 89 Days

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Gender

ALL

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Sponsor

Vaxcyte, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Jonesboro

Arkansas

Location available
View Jonesboro location page
RECRUITING

Gardena

California

Location available
View Gardena location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Ontario

California

Location available
View Ontario location page
RECRUITING

West Covina

California

Location available
View West Covina location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Pensacola

Florida

Location available
View Pensacola location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Idaho Falls

Idaho

Location available
View Idaho Falls location page

๐Ÿ“ And 42 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 Pneumonia Treatment in Jonesboro?

Join others in Arkansas exploring innovative treatment options through clinical research

Pneumonia Treatment Options in Jonesboro, Arkansas

If you're searching for Pneumonia treatment in Jonesboro, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Jonesboro, Gardena, Los Angeles 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 Pneumonia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arkansas
Now Enrolling
Up to 900 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Pneumonia?

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 Pneumonia

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 Pneumonia 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: NCT06720038. 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.