Phase III Study of Intramuscular TAK-816 in Healthy Infants

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.

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.