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Interim Analysis of a Randomized, Open-Label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-Valent Polysaccharide Pneumococcal Vaccine
Abstract   Open access   Peer reviewed

Interim Analysis of a Randomized, Open-Label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-Valent Polysaccharide Pneumococcal Vaccine

Kei Nakashima, Masahiro Aoshima, Satoko Ohfuji, Satoshi Yamawaki, Masahiro Nemoto, Shinya Hasegawa, Satoshi Noma, Masafumi Misawa, Naoto Hosokawa, Makito Yaegashi, …
Open forum infectious diseases, Vol.3(suppl_1)
2016
DOI: 10.1093/ofid/ofw172.650
url
https://doi.org/10.1093/ofid/ofw172.650View
Published (Version of record) Open Access

Abstract

Background. In 2015/2016 season, quadrivalent influenza vaccine (QIV) became available in Japan instead of trivalent influenza vaccine. We evaluated the immunogenicity and safety of simultaneous administration of QIV and 23-valent pneumococcal polysaccharide vaccine (PPV). Methods. This study was a randomized, non-inferiority, open label trial conducted at Kameda Medical Center, Chiba, Japan, from November 2015 to August 2016. Adults aged 65 years or more were randomly assigned to one of the following two study groups: simultaneous administration group (SIM group) received injections of PPV and QIV simultaneously; sequential administration group (SEQ group) received injection of PPV at 2 weeks after injection of QIV. The primary end point was the percentage of patients with positive antibody response against serotype 23F of pneumococcal antibody. The secondary end points included positive antibody response in serotype (3, 4, 6B, 14 and 19A), geometric mean concentrations of specific antibodies to 6 serotypes (23F, 3, 4, 6B 14 and 19A) at 4 to 6 weeks after vaccination and at 24 weeks to 27 weeks after vaccination, and percentage of patients with seroprotection for 4 strains at 4 to 6 weeks after vaccination. In addition, the proportion of patients which reported adverse reactions during 28 days were compared by using χ2 test. This trial was registered with the ClinicalTrials.gov, number NCT02592486. Results. After excluded 5 withdrawals, 81 patients in SIM group and 76 patients in SEQ group were evaluated. Systemic reactions were fever (in 2.5% of patients in SIM group and 4.2% of patients with SEQ group; p = 0.668), fatigue (in 11.1% and 21.1%; p = 0.138), headache (in 4.9% and 6.6%; p = 0.740), joint pain (in 13.6% and 14.5%; p = 1.000), pain of axilla (in 4.9% and 5.3%; p = 1.000), rash (in 1.2% and 2.6%; p = 0.611). Local reactions from PPV were induration (in 24.7% and 18.4%; p = 0.448), itch (in 19.8% and 15.8%; p = 0.660), pain (in 34.6% and 47.4%; p = 0.142), redness (in 28.4% and 25%; p = 0.764), swelling (in 29.6% and 17.1%; p = 0.097). Local reactions from QIV were induration (in 23.5% and 14.5%; p = 0.220), itch (in 22.2% and 18.4%; p = 0.695), pain (in 28.4% and 18.4%; p = 0.199), redness (in 24.7% and 23.7%; p = 1.000), swelling (in 23.5% and 18.4%; p = 0.563). Conclusion. There were no significant differences in adverse reactions between SIM group and SEQ group. We will show the immunogenicity analysis at 4 to 6 week after vaccination on October 2016.

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