Actively Recruiting

Phase 2
Age: 42Days - 49Days
All Genders
Healthy Volunteers
NCT06879327

Infant Malaria Vaccine Schedule Optimization

Led by PATH · Updated on 2025-08-03

1200

Participants Needed

2

Research Sites

146 weeks

Total Duration

On this page

Sponsors

P

PATH

Lead Sponsor

S

Serum Institute of India PVT LTD (SII)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Infant Malaria Vaccine Schedule Optimization

Who Can Participate

Age: 42Days - 49Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent or thumb-printed and witnessed informed consent from parent/legal guardian
  • Infant born full-term (≥37 weeks gestation) and weighing over 2500 grams at birth
  • Male or female infants aged 42-49 days (6 to 7 weeks) at enrollment for Cohort 1, 56-63 days (2 months) for Cohort 2, or 84-91 days (3 months) for Cohort 3
  • Parent/guardian willing to avoid travel especially within 28 days after each vaccination and able to contact study team if travel occurs
  • Parent/guardian willing and able to bring child to clinic visits and contact study team for illness or concerns
  • Investigator believes parent/guardian can comply with study requirements including follow-up visits
Not Eligible

You will not qualify if you...

  • Presence of moderate or severe acute illness at enrollment (minor illnesses like mild upper respiratory infection without fever allowed)
  • Significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, liver, or kidney abnormalities that pose risk or affect trial results
  • Prior receipt of hexavalent/pentavalent, pneumococcal, rotavirus, inactivated polio, more than one dose of oral polio, or more than one dose of hepatitis B vaccine before enrollment
  • Weight-for-height/length Z score below -3 or clinical signs of malnutrition
  • Major congenital defects
  • Anemia with symptoms or hemoglobin ≤5.0 g/dL
  • History of allergic reactions to vaccine components
  • Confirmed or suspected immunosuppressive or immunodeficient state including HIV or known maternal HIV infection
  • Receipt of immunoglobulins or blood transfusions from birth to planned vaccine administration
  • Previous malaria vaccination of participant or biological mother
  • Participation in another investigational study or use of investigational products during study period
  • Any other condition the investigator believes increases risk of adverse outcome during the trial

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Institut de Recherche en Science de la Santé (IRSS)

Bobo-Dioulasso, Burkina Faso

Actively Recruiting

2

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, Burkina Faso

Actively Recruiting

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Research Team

M

Michael Thigpen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

6

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