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