Healthy VolunteersPhase 3NCT02074345
Phase III Study of Intramuscular TAK-816 in Healthy Infants
A Phase 3 study testing TAK-816 in people with Healthy Volunteers and Haemophilus Influenzae Type b, Prevention, run by Takeda at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Haemophilus Influenzae Type b, Prevention
- What is being tested?
- TAK-816
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesJapan
- Study dates
- Mar 2014to Mar 2015
- Phase
- Phase 3
- 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Japanese infants.
- Male or female infants aged 2-6 months (≥2 and <7 months) at the time of the first dose of investigational product (excluding hospitalized infants).
- Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
- The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.
Who cannot join
- Any serious acute illness.
- Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
- History of possible Haemophilus influenzae type b (Hib) infection.
- Previously diagnosed immunodeficiency.
- Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
- A history of convulsions.
Show all 12Show fewer
- Previous administration of another Hib vaccine.
- Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
- Prior participation in any clinical study or post-marketing clinical study.
- Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal antibody products not containing any components of Hib as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period.
- Presence of thrombocytopenia or coagulopathy.
- Children considered ineligible for the study for other reasons by the investigator or subinvestigator.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Fuchu-shi, Tokyo
Study site
Kofu, Yamanashi
Study site
Kumagaya-shi, Saitama
Study site
Suginami-ku, Tokyo
About this study
Official title: A Phase III, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
Read the detailed description
The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.
The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.
This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
- Being tested
- TAK-816
- Keywords
- Drug therapy, Safety and immunogenicity of Hib vaccine
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-816Biological
TAK-816 intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-816 0.5 mL | Experimental | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. Receives: Biological: TAK-816 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.
Measured: For 64 Weeks
Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)
Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.
Measured: For 64 Weeks
Number of Participants With Adverse Reactions Related to Local Reactions
Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).
Measured: For 64 Weeks
Number of Participants With Adverse Reactions Related to Systemic Reactions
Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).
Measured: For 64 Weeks
Secondary outcomes (3)
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.
Measured: For 64 weeks
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.
Measured: For 64 weeks
Geometric Mean Titer (GMT) of Anti-PRP Antibody
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.
Measured: For 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074345
- Sponsor's protocol ID
- TAK-816/OCT-002
- Other IDs
- U1111-1153-4027, JapicCTI-142454
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2014
- Last updated
- 26 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Togashi T, Mitsuya N, Sumino S, Takanami Y. Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial. Vaccine. 2018 May 17;36(21):2968-2972. doi: 10.1016/j.vaccine.2018.04.040. Epub 2018 Apr 20.
PubMed 29685594
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants
- ClinicalTrials.gov ID
- NCT02074345
- Acronym / sponsor ID
- TAK-816/OCT-002
- Keywords
- Drug therapy, Safety and immunogenicity of Hib vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Posted 26 Apr 2016
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 the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
Detailed description
The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.
The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.
This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-816 0.5 mL | Experimental | Biological: TAK-816Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy Japanese infants.
- Male or female infants aged 2-6 months (≥2 and <7 months) at the time of the first dose of investigational product (excluding hospitalized infants).
- Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
- The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.
Key exclusion criteria (12 listed)
- Any serious acute illness.
- Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
- History of possible Haemophilus influenzae type b (Hib) infection.
- Previously diagnosed immunodeficiency.
- Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
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 |
|---|---|---|
| TAK-816TAK-816 intramuscular injection | Biological | TAK-816 0.5 mL |
Primary outcome
Number of Participants With Adverse Events
Time frame: For 64 Weeks
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.
Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)
Time frame: For 64 Weeks
Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.
Number of Participants With Adverse Reactions Related to Local Reactions
Time frame: For 64 Weeks
Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).
Number of Participants With Adverse Reactions Related to Systemic Reactions
Time frame: For 64 Weeks
Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).
3 secondary outcomes
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
Time frame: For 64 weeks
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
Time frame: For 64 weeks
Geometric Mean Titer (GMT) of Anti-PRP Antibody
Time frame: For 64 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29685594Togashi T, Mitsuya N, Sumino S, Takanami Y. Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial. Vaccine. 2018 May 17;36(21):2968-2972. doi: 10.1016/j.vaccine.2018.04.040. Epub 2018 Apr 20.
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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.
Senior Manager study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAK-816 in people with Healthy Volunteers and Haemophilus Influenzae Type b, Prevention, run by Takeda at 4 sites 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 4 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Apr 2016). 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?
Number of Participants With Adverse Events (time frame: For 64 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074345, which also lists 1 linked publication.
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 26 Apr 2016.