Could a Lower-Dose polio vaccine help eradicate the disease?
NCT ID NCT06413121
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a hexavalent vaccine that protects against six diseases, including polio, but uses a lower dose of the inactivated polio vaccine (IPV). The goal is to see if this reduced-dose version works as well as the standard full-dose vaccine in infants. Around 1,500 healthy infants aged 6-8 weeks will receive three primary doses and a booster. If effective, this approach could lower costs and increase vaccine supply, aiding global polio eradication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hexavalent (DTwP-HepB-IPV-Hib) vaccine with reduced dose IPV
- What this could lead to
- If successful, this vaccine could help make polio protection more affordable and available worldwide, supporting global eradication efforts.
- What could go wrong
- This is a phase 3 trial, but reducing the IPV dose might still result in lower immune responses for some infants. Safety and effectiveness need confirmation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,557 people
The number who actually took part.
- Started
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May 2024
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 8 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female infants aged 6-8 weeks at the time of first vaccination. * Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator. * Informed consent form signed by at least one parent. * Infants born at full term pregnancy (≥ 37 weeks). * Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment. * Willingness of subjects' parent to comply with the requirements of the protocol. Exclusion Criteria: * History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae type b/ poliomyelitis infection(s). * Presence of fever ≥ 38°C/ 100.4°F. * Acute illness of moderate to severe intensity according to the clinical judgment of the investigator . * Receipt of antibiotics in the past 3 days * Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period. * Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination. * History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment. * History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives. * History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine. * Infants with known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to study entry * Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy. * Known thrombocytopenia or a bleeding disorder. * Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity. * Planned surgery during the study. * Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response. * Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial. * Infants whose families are planning to leave the area of the study site before the end of the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, 411043, India
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Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH)
New Delhi, National Capital Territory of Delhi, 110062, India
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Institute of Child Health, Kolkata
Kolkata, West Bengal, 700017, India
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International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Kamalapur Field office, Lichubagan Rd
Dhaka, Dhaka Division, 1204, Bangladesh
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International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b), Clinical Trial Unit (CTU), Adjacent to the main center, 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka
Dhaka, Dhaka Division, 1212, Bangladesh
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International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b), Matlab Field office, MHRC Internal Road, Matlab Bazar
Chāndpur, 3640, Bangladesh
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JSS Medical College and Hospital
Mysore, Karnataka, 570004, India
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KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, 412216, India
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Manipal Academy of Higher Education, Manipal
Mangalore, Karnataka, 576104, India
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Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, Chandigarh, 160012, India
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Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, 600116, India