New combo vaccine for infants shows promise in early trial
NCT ID NCT02140047
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new vaccine called MT-2301, which protects against Haemophilus influenzae type b (Hib), given together with the standard DPT-IPV vaccine (which protects against diphtheria, pertussis, tetanus, and polio). The trial involved 154 healthy infants aged 2 to 7 months. Researchers compared two doses of MT-2301 against an existing Hib vaccine (ActHIB) to see how well they triggered protective antibodies and whether they were safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Haemophilus b conjugate vaccine (MT-2301) combined with DPT-IPV vaccine
- What this could lead to
- If successful, this could lead to a new combination vaccine that protects infants against Hib disease, diphtheria, pertussis, tetanus, and polio with fewer injections.
- What could go wrong
- This is a Phase 2 trial with 154 participants, so results are preliminary. The new vaccine may not be as effective or safe as the existing vaccine (ActHIB).
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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154 people
The number who actually took part.
- Start date
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Apr 2014
- Finished
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Sep 2015
- 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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2 to 7 months
- 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: * Healthy infants aged ≥2 and \<7 months at the first vaccination of the study drug * Written informed consent is obtained from a legal guardian (parent) Exclusion Criteria: * With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug * With known serious acute disease * With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease * With past diagnosis of immunodeficiency or currently under immunosuppressive treatment * History of anaphylaxis due to food or pharmaceuticals * With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis * With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent * History of convulsions * Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week * Participated in other studies within 12 weeks before obtaining consent
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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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Investigational site
Fukuoka, Fukuoka, Japan