Phase III Study of Intramuscular TAK-816 in Healthy Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

Detailed Description
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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.

Official Title
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A Phase III, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants

Conditions
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Healthy Volunteers, Haemophilus Influenzae Type b, Prevention

Intervention / Treatment
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* Biological: TAK-816


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-816 0.5 mL<br>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. | Biological: TAK-816<br>* TAK-816 intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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). | For 64 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | For 64 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy, Safety and immunogenicity of Hib vaccine