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Understanding Children's Immune Response to Vaccines

This study aims to understand how healthy children's bodies react to common vaccinations. Researchers will measure changes in certain immune markers (interleukin-1 beta, interleukin-6, and tumor necrosis factor-alpha) in the blood before and one week after vaccination. This will help define what a normal immune response looks like, which can then be used to understand children who don't respond normally to infections. You might be able to join if your child is 5-7 months old and receiving their DTaP-IPV/Hib+PCV13 vaccine, or 10-18 months old and receiving their MMR+VZV vaccine. This is an observational study, meaning researchers will simply collect information without giving any new treatments. The study is planning to enroll 300 children, but its current status is unclear.

Study design
This is an observational study, meaning researchers will collect information without providing any new treatments. It plans to enroll 300 healthy children.
What's involved
Your child would have a small amount of blood collected just before receiving their standard vaccinations and again one week later.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at baseline and 1 week after immunization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04112355

Measuring the Healthy Pediatric Inflammatory Response to Vaccination.

Enrolling by Invitation
Not specifiedAges 4–21Observational
Mayo Clinic
~300 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Blood Collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in normal pediatric interleukin-1 beta levels in serum at 1 week after immunization relative to baseline.
Measured over Baseline, 1week
+10 more outcomes measured

Conditions

Healthy Controls

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Healthy Controls

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children 5-7 months of age receiving the 3rd scheduled dose of the diphtheria, tetanus, pertussis, inactivated polio, Haemophilus influenzae type b, and pneumococcal conjugate vaccine (DTap-IPV/Hib+PCV13).
Children 10-18 months of age receiving the 1st scheduled dose of the measles, mumps, rubella, and varicella vaccine (MMR+VZV).
Children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose.
Children and young adults receiving the annual flu vaccine or COVID vaccine

Exclusion

History of autoinflammatory or autoimmune disease.
History of genetic or metabolic disorder.
History of hematological disorder.
History of malignancy or active malignancy undergoing suppressive treatment.
Blood donation or collection within 8 weeks of the study.
Signs or symptoms consistent with severe infection at the time of first visit.
Weight less than 6 kg in group 1, less than 7.5 kg for group 2, less than 12 kg for group 3.

What this trial measures

  • Changes in normal pediatric interleukin-1 beta levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum interleukin-1 beta levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric interleukin-6 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum interleukin-6 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric tumor necrosis factor-alpha levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum tumor necrosis factor-alpha levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-C motif) ligand 2 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-C motif) ligand 2 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-C motif) ligand 5 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-C motif) ligand 5 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-X-C motif) ligand 1 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-X-C motif) ligand 1 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-X-C motif) ligand 2 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-X-C motif) ligand 2 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-X-C motif) ligand 8 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-X-C motif) ligand 8 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-X-C motif) ligand 9 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-X-C motif) ligand 9 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Changes in normal pediatric chemokine (C-X-C motif) ligand 10 levels in serum at 1 week after immunization relative to baseline.Baseline, 1week

    Measurement of serum chemokine (C-X-C motif) ligand 10 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  • Determine the range of normal single nucleotide polymorphisms in the interleukin-1 receptor antagonist (IL-1RN) gene.Baseline

    The IL-1RN gene will be sequenced from genomic DNA. Sequences will be compared between subjects and associated with cytokine and chemokine levels.