Phase 3
Completed N=31
Phase III Study of Intramuscular TAK-816 in Healthy Infants
Healthy Volunteers · Haemophilus Influenzae Type b, Prevention
Source: ClinicalTrials.gov NCT02074345 ↗
Enrolled (actual)
31
Serious AEs
12.9%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Adverse Events — 31 participants
◆ Published Evidence
Emerging
3citations · ~0 / year
Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM<sub>197</sub> Hib vaccine to healthy Japanese children: An open-label trial.
Summary
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.
Linked Publications
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Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM<sub>197</sub> Hib vaccine to healthy Japanese children: An open-label trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
31 | — |
| PRIMARY Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia) |
6 | — |
| PRIMARY Number of Participants With Adverse Reactions Related to Local Reactions |
5; 1; 1; 0 | — |
| PRIMARY Number of Participants With Adverse Reactions Related to Systemic Reactions |
0; 0; 3; 0; 1; 5 | — |
| SECONDARY Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL |
16.1; 100; 77.4; 100 | — |
| SECONDARY Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL |
87.1; 100; 100; 100 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-PRP Antibody |
0.354; 19.682; 3.087; 51.334 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02074345) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.