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NCT06816524

The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Nicole Stoffel

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 13 words
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 5, 2026 to Mar 13, 2026
    • Interventions: Iron syrup (Dietary Supplement), Measles-Rubella vaccine (Biological), Multivitamin syrup (Dietary Supplement), R21-Matrix/M Vaccine… to Iron syrup (Dietary Supplement), Measles-Rubella vaccine (Biological), Multivitamin syrup (Dietary Supplement), R21-Matrix/M Vaccine…
    • Secondary endpoints: 58 to 24
    • Study title shortened, about 3 words
  2. Lead sponsor: Swiss Federal Institute of Technology to Nicole Stoffel
    • Start date: Jul 1, 2025 to Jan 5, 2026
    • Primary completion date: Sep 1, 2027 to Dec 31, 2027
    • Study completion date: Dec 31, 2027 to Apr 30, 2028
    v3
  3. Start date: Mar 1, 2025 to Jul 1, 2025v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

NANP-specific IgG
Timeframe: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Anti-measles IgG
Timeframe: At 10 months of age (1 month after MR vaccine administration)

Secondary (17)

Anti-typhoid IgG
C-terminal-specific IgG
NANP-specific IgG
Full-length CSP-specific IgG
NANP-specific IgM
Show 12 moreShow less
NANP-specific IgA
NANP-specific IgG4
NANP-specific IgG3
NANP-specific IgG2
NANP-specific IgG1
IgG avidity to measles antigen
IgG avidity to typhoid antigen
IgG avidity to NANP-specific CSP
IgG avidity to C-terminal CSP
Full-length CSP-specific IgG seropositivity
C-terminal-specific IgG seropositivity
NANP-specific IgG seropositivity

Arms and interventions

Iron treatment groupActive comparator

daily multivitamin + daily iron syrup from age 6 to 10 months

Control groupOther

daily multivitamin syrup from age 6 to 10 months

Dietary supplements: Iron syrup, Multivitamin syrup

Biologicals: R21-Matrix/M Vaccine (malaria vaccine), Measles-Rubella vaccine

Sites

1 site in 1 country

  • Msambweni District HospitalMsambweni, Kwale County, Kenya