Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China

Abstract

A split-virion trivalent inactivated influenza vaccine produced according to the Chinese pharmacopeia (Shz-IIV3) has been commercially available in China since 2014. Here, we describe the results of a phase IV open-label trial to describe the immunogenicity and safety of the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 in individuals ≥ 6 months of age. Subjects 6–35 months of age received 2 half-doses of Shz-IIV3 (0.25 ml) 28 d apart, and subjects ≥ 3 y of age received a single full dose (0.5 ml). The study included 602 subjects. Except for the A (H3N2) strain in subjects 3–17 years, geometric mean hemagglutination inhibition titer ratios were ≥ 10 and rates of seroconversion/significant increase in titer were ≥ 78% in all age groups. For the H3N2 strain in subjects 3–17 years, the geometric mean titer ratio was 3.8 and the rate of seroconversion/significant increase was 56%. Post-vaccination seroprotection rates were ≥ 88% for all strains in all age groups. The most common solicited reactions were injection-site pain/tenderness and fever, most of which were grade 1 and resolved within 3 d. Vaccine-related unsolicited adverse events were reported only by subjects 6–23 months, most of which were mild abnormal crying and irritability. No vaccine-related serious adverse events and no deaths were reported. No new safety signals or unexpected safety events occurred, although an immediate anaphylactic skin reaction occurred in one subject. This study confirmed that the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 was well tolerated and highly immunogenic in subjects ≥ 6 months of age.

Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study

“…Solicited injection site reactions were reported by similar proportions of subjects in the Shz-IIV3 and comparator IIV3 groups (31.4% vs. 33.0%), as were solicited systemic reactions (12.8% vs. 12.1%) ( Table 3). Consistent with other studies of IIV3, 10,16 the most frequently reported solicited reactions in each group were malaise, myalgia, and pain and erythema at the injection site (Supplemental Table 1). For both groups, most solicited reactions were grade 1 (mild) in intensity and most resolved within 3 days.…”

“…These results are in line with an earlier study that showed the 2014-2015 Northern Hemisphere formulation of Shz-IIV3 was highly immunogenic in Chinese individuals ≥6 months of age. 10 Post-vaccination HAI GMTs and seroconversion rates for Shz-IIV3 were statistically non-inferior to those for the comparator IIV3, for all three vaccine strains ( Table 2). Because non-inferiority was shown for all six analyses, Shz-IIV3 was considered to demonstrate overall non-inferiority versus the comparator vaccine.…”

“…9 Since 2013, a split virion trivalent inactivated influenza vaccine (IIV3) has been produced by the Sanofi Pasteur facilities based at Shenzhen, China (Shz-IIV3) according to Chinese pharmacopeia requirements. 10 Shz-IIV3 is well tolerated and highly immunogenic in Chinese individuals aged ≥ 6 months, 10 but its immunogenicity and safety compared to existing IIV3s in China have not been assessed. Here we report the results of an observer-blind randomized study to evaluate whether the immunogenicity of Shz-IIV3 was noninferior to a comparator IIV3 also manufactured in China (Hualan trivalent influenza vaccine [split virion, inactivated]; Hualan Biological Engineering Inc, China) in healthy adults aged 18-59 years.…”

Análise da segurança e da imunogenicidade da vacina influenza sazonal trivalente (fragmentada e inativada) integralmente produzida pelo Instituto Butantan em 2013, 2014 e 2015

“…Ao longo dos anos, vários estudos clínicos pré e pós comercialização, com vacinas de influenza trivalente sazonal (fragmentada e inativada), semelhantes à vacina produzida pelo IB, foram realizados (33)(34)(35)(36)(37)(38)(39)(40) .…”

“…A reação adversa local observada com maior frequência, tanto em adultos quanto nos idosos, nos três estudos, foi dor no local da aplicação da vacina, e a sistêmica cefaleia. Tais reações adversas também têm sido descritas na literatura como as principais reações adversas associadas a imunização com vacina influenza sazonal trivalente e inativada (33,(35)(36)(37) . Os poucos episódios de febre observados também são reconhecidos como potenciais reações adversas associadas a este tipo de vacina e não são considerados graves ou associados às complicações (52) .…”