Haemophilus Influenza Type bPhase 2NCT02140047
Exploratory Clinical Study of MT-2301
A Phase 2 study testing Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV, Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV and Haemophilus influenza type b conjugate vaccine + DPT-IPV in people with Haemophilus Influenza Type b, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants. Read more about this study
- Who is it for?
- Ages 2 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenza Type b
- What is being tested?
- Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV, Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV and Haemophilus influenza type b conjugate vaccine + DPT-IPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.
- Conditions
- Haemophilus Influenza Type b
- Being tested
- Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV, Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV, Haemophilus influenza type b conjugate vaccine + DPT-IPV
- Keywords
- Haemophilus influenza type b, Hib
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPVBiological
Also called MT-2301-Low + Tetrabik®
0.25mL, subcutaneous injection
Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPVBiological
Also called MT-2301-High + Tetrabik®
0.5mL, subcutaneous injection
Haemophilus influenza type b conjugate vaccine + DPT-IPVBiological
Also called ActHIB® + Tetrabik®
0.5mL, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MT-2301-Low | Experimental | Not described Receives: Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV |
| MT-2301-High | Experimental | Not described Receives: Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV |
| ActHIB | Active comparator | Not described Receives: Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Measured: 4 weeks after the primary immunization (Visit 4)
Secondary outcomes (13)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Measured: 4 weeks after the booster dose (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haemophilus Influenza Type bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takashi Nakano, M.D., Ph.D., Study director, Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140047
- Sponsor's protocol ID
- MT-2301-J01
- Status last verified
- Mar 2026
- First submitted
- 14 May 2014
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
- ClinicalTrials.gov ID
- NCT02140047
- Acronym / sponsor ID
- MT-2301-J01
- Conditions
- Haemophilus Influenza Type b
- Keywords
- Haemophilus influenza type b, Hib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-2301-Low | Experimental | Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV |
| MT-2301-High | Experimental | Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV |
| ActHIB | Active comparator | Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV |
Who may qualify
- Ages
- 2 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPVAlso: MT-2301-Low + Tetrabik®0.25mL, subcutaneous injection | Biological | MT-2301-Low |
| Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPVAlso: MT-2301-High + Tetrabik®0.5mL, subcutaneous injection | Biological | MT-2301-High |
| Haemophilus influenza type b conjugate vaccine + DPT-IPVAlso: ActHIB® + Tetrabik®0.5mL, subcutaneous injection | Biological | ActHIB |
Primary outcome
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Time frame: 4 weeks after the primary immunization (Visit 4)
13 secondary outcomes
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: 4 weeks after the booster dose (Visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takashi Nakano, M.D., Ph.D. study director
Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV, Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV and Haemophilus influenza type b conjugate vaccine + DPT-IPV in people with Haemophilus Influenza Type b, run by Tanabe Pharma Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP (time frame: 4 weeks after the primary immunization (Visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.