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Infant Malaria Vaccine Schedule Optimization

StatusActive, Not Recruiting
PhasePhase 2
SponsorPATH
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing Show 8 more changesShow less
    • Enrollment target: estimated 964 to confirmed 975
    • Primary and study completion dates: Sep 27, 2027 to Oct 18, 2027
    • Interventions: Hexavalent Vaccine (Biological), Measles and Rubella Vaccine (Biological), Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine… to Hexavalent Vaccine (Biological), Measles and Rubella Vaccine (Biological), Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine…
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
    • Collaborators: 5 to 9
  2. Enrollment target: 1200 to 964v4 Show 8 more changesShow less
    • Primary and study completion dates: Mar 22, 2028 to Sep 27, 2027
    • Interventions: Hexavalent Vaccine (Biological), Measles and Rubella Vaccine (Biological), Meningococcal A conjugate vaccine (Biological), Placebo… to Hexavalent Vaccine (Biological), Measles and Rubella Vaccine (Biological), Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine…
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: 8 to 2
    • Study description expanded, about 285 words
    • Study sites revised (2)
    • Collaborators revised (5)
    • Study arms: 6 to 4
  3. Primary and study completion dates: Nov 26, 2027 to Mar 22, 2028
    • Site details revised at 2 of 2 sites
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2, 2025 to May 30, 2025
    • Site details revised at 2 of 2 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PATH
7 trials monitored
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The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.
Trial Details
NCT Number NCT06879327
Lead Sponsor PATH
Collaborators: Pharmassist Ltd, Serum Institute of India Pvt. Ltd., Agilis, MCT-CRO, Cytespace, CERBA, Christian Medical College, Vellore, India, University College London - Institute of Child Health (UCL-ICH), VisMederi srl, Sienna, Italy
Conditions
(from sponsor)		 Malaria Vaccines, Malaria (Plasmodium Falciparum)
Related terms Malaria, Falciparum
Enrollment 975 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov