Article in Japanese

Randomized controlled trial assessing the safety and immunogenicity of 7-valent pneumococcal conjugate vaccine given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine in japanese infant

Kenji OKADA¹⁾, Takehiro TOGASHI²⁾, Kousuke TANABE³⁾, Masako YAMAJI³⁾, Michael PRIDE⁴⁾, Alejandra GURTMAN⁴⁾, Mizuki YOSHIDA³⁾, Allison THOMPSON⁴⁾, William C. GRUBER⁴⁾, Daniel A. SCOTT⁴⁾

Background: The safety, tolerability, and immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV7) have been demonstrated in Japanese infants, and PCV7 was licensed in Japan since December 2009. This open-label, randomized, clinical trial was designed to evaluate the safety, tolerability, and immunogenicity of PCV7 and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) administered concomitantly to Japanese infants.
Methods: Healthy infants aged 3 to 6 months were randomized 1: 1 to receive 4 subcutaneous doses of DTaP and PCV7 or DTaP alone. Immune responses to DTaP antigens and PCV7 serotypes were measured 1 month after dose 3 and 1 month after the toddler dose. Local reactions and systemic events were assessed for 7 days after vaccination; adverse events (AEs) were recorded.
Results: 321 infants (PCV7+DTaP: 161, DTaP: 160) were enrolled at 18 sites. All subjects in both groups achieved the prespecified antibody levels for all the DTaP antigens after both the infant series and the toddler dose. In the PCV7+DTaP group, 97.7% to 100% of subjects achieved the prespecified serotype-specific pneumococcal antibody levels after the infant series and 99.2% to 100% after the toddler dose. PCV7+DTaP was well tolerated. AEs were generally consistent with common childhood illnesses.
Conclusion: Subcutaneous coadministration of PCV7 and DTaP in Japanese infants was safe and well tolerated and did not interfere with immune responses to either vaccine.

---

1) Section of Pediatrics, Department of Medicine, Division of Oral & Medical Management Fukuoka Dental College
2) Sapporo City University School of Nursing
3) Pfizer Japan Inc
4) Vaccine Research, Pfizer Inc

Key words
Received	April 4, 2016
Accepted	October 13, 2016

28 (4)：225─235,2017