Journal List > Pediatr Infect Vaccine > v.25(1) > 1098702

Ri, Kim, and Kim: Immunogenicity and Safety of Inactivated Influenza Vaccine in Healthy Korean Children and Adolescent

Abstract

Purpose

This study aimed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine (TIV) among healthy Korean children and adolescents.

Methods

From October to December 2008, 65 healthy patients aged 6 months to 18 years who visited Korea University Ansan Hospital for influenza vaccination were enrolled in this study. We measured the hemagglutinin inhibition antibody titers at baseline and 30 days after vaccinating enrollees with split influenza vaccine and calculated the seroprotection rates, geometric mean titers, and seroconversion rates. Local and systemic adverse events were assessed after vaccination.

Results

The seroprotection rates against all three viral strains (A/H1N1, A/H3N2, B) were 87.7%, 89.2%, and 89.2% (≥70%), respectively; seroconversion rates were 44.6%, 73.8%, and 63.1% (≥40%), respectively; and seroconversion factors were 4.5, 8.4, and 10.5 (>2.5), respectively. The TIV immunogenicity was acceptable according to the CPMP (Committee for Proprietary Medicinal Products) criteria. Although 48 patients (73.8%) reported one or more adverse events, no severe adverse events such as anaphylaxis and convulsion were observed. Forty-two patients (64.6%) reported a local skin reaction, including redness (29.2%), pain (43.1%), or swelling (41.5%) of the injected site, and 26 (40.0%) reported a systemic reaction: fatigue (23.1%), myalgia (20.0%), headache (10.8%), arthralgia (10.8%), chills (9.2%), or fever (7.7%).

Conclusions

This study shows that the immunogenicity of the TIV vaccine is acceptable. As there were no serious adverse events aside from local reactions and mild systemic reactions, this vaccine can be safely used among healthy Korean children and adolescents.

References

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Table 1.
Demographic Characteristics
Characteristic Total subjects (n=65)
Age  
  6–59 mo 31 (47.7)
  5–18 yr 34 (52.3)
Mean age (yr) 5.9±4.1
Sex  
  Male 33 (50.8)
  Female 32 (59.2)
Pre-vaccination history  
  Primed 57 (87.7)
  Unprimed 8 (12.3)

Values are presented as number (%) or mean±standard deviation.

Table 2.
Immunogenicity of Subjects
  A/H1N1 A/H3N2 B C CPMP standards
Seroprotection rate (%) 87.7 89.2 89.2 ≥70%
Seroconversion rate (%) 44.6 73.8 63.1 ≥40%
GMT ratio 4.5 8.4 10.5 >2.5-fold

Abbreviation: CPMP, committee for proprietary medicinal products; GMT, geometric mean titer.

Table 3.
Comparison of Immunogenicity of Influenza Vaccine According to Age Groups
  6–59 mo (n=31) 5–18 yr (n=34) Total (n=65) Pvalue
H1N1        
  Pre-vaccination HI Ab ≥1:40 (%) 11 (35.5) 25 (73.5) 36 (55.4) <0.001
  Post-vaccination HI Ab ≥1:40 (%) 25 (80.6) 32 (94.1) 57 (87.7) 0.021
  Seroconversion (%) 16 (51.6) 13 (38.2) 29 (44.6) 0.398
  Pre-vaccination GMT 20.0 72.0 38.3 0.015
  Post-vaccination GMT 134.5 219.3 172.4 0.329
  GMT ratio 6.7 3.0 4.5 0.026
H3N2        
  Pre-vaccination HI Ab ≥1:40 (%) 10 (32.3) 20 (58.8) 30 (46.1) 0.017
  Post-vaccination HI Ab ≥1:40 (%) 26 (83.9) 32 (94.1) 58 (89.2) 0.042
  Seroconversion (%) 25 (80.6) 23 (67.6) 48 (73.8) 0.620
  Pre-vaccination GMT 16.8 36.0 27.8 0.194
  Post-vaccination GMT 170.7 313.3 232.4 0.107
  GMT ratio 8.5 8.7 8.4 0.284
B        
  Pre-vaccination HI Ab ≥1:40 (%) 5 (16.1) 18 (52.9) 23 (35.4) <0.001
  Post-vaccination HI Ab ≥1:40 (%) 26 (83.9) 32 (94.1) 58 (89.2) 0.042
  Seroconversion (%) 23 (74.2) 18 (52.9) 41 (63.1) 0.152
  Pre-vaccination GMT 8.8 33.1 17.2 0.004
  Post-vaccination GMT 128.8 248.7 179.9 0.126
  GMT ratio 6.4 7.5 10.5 0.024

Values are presented as number (%).

GMT ratio is defined as division of post-GMT by pre-GMT.

Abbreviations: HI, hemagglutinin inhibition; GMT, geometric mean titer.

Table 4.
Comparison of Immunogenicity of Influenza Vaccine between Primed and Unprimed Group
  Primed (n=57) Unprimed (n=8) P-value
H1N1      
  Pre-vaccination HI Ab ≥1:40 (%) 34 (59.6) 2 (25.0) 0.065
  Post-vaccination HI Ab ≥1:40 (%) 52 (91.2) 5 (62.5) 0.021
  Seroconversion (%) 24 (42.1) 5 (62.5) 0.284
  Pre-vaccination GMT 43.6 15.4 0.305
  Post-vaccination GMT 180.7 123.4 0.370
  GMT ratio 4.1 8.0 0.405
H3N2      
  Pre-vaccination HI Ab ≥1:40 (%) 28(49.1) 2 (25.0) 0.200
  Post-vaccination HI Ab ≥1:40 (%) 50 (87.7) 8 (100.0) 0.294
  Seroconversion (%) 41 (71.9) 8 (100.0) 0.084
  Pre-vaccination GMT 27.8 10.9 0.153
  Post-vaccination GMT 224.9 293.4 0.588
  GMT ratio 8.1 26.9 0.033
B      
  Pre-vaccination HI Ab ≥1:40 (%) 22 (38.6) 1 (12.5) 0.148
  Post-vaccination HI Ab ≥1:40 (%) 51 (89.5) 7 (87.5) 0.866
  Seroconversion (%) 34 (59.6) 7 (87.5) 0.126
  Pre-vaccination GMT 19.3 7.7 0.140
  Post-vaccination GMT 174.2 226.3 0.610
  GMT ratio 9.0 29.4 0.059

Values are presented as number (%).

GMT ratio is defined as division of post-GMT by pre-GMT.

Abbreviations: HI, hemagglutinin inhibition; GMT, geometric mean titer.

Table 5.
Local and Systemic Adverse Events
  Total (n=65) Age Pre-vaccination status
6–59 mo (n=31) 5–18 yr (n=34) P-value Primed (n=57) Unprimed (n=8) P-value
Subjects experiencing local reactions (%) 42 (64.6) 14 (45.1) 28 (82.3) <0.001 41 (71.9) 2 (25.0) 0.008
  Redness 32 (49.2) 6 17 0.268 31 1 0.026
  Pain 28 (43.1) 3 13 <0.001 27 1 0.042
  Swelling 27 (41.5) 2 15 0.026 27 0 0.013
Subjects experiencing systemic reactions (%) 26 (40.0) 8 (25.8) 18 (52.9) 0.007 24 (42.1) 4 (50.0) 0.679
  Fever 5 (7.7) 3 2 0.573 4 1 0.593
  Chill 6 (9.2) 1 5 0.114 6 0 0.343
  Fatigue 15 (23.1) 3 12 0.014 13 2 0.892
  Headache 7 (10.8) 0 7 0.003 7 0 0.265
  Myalgia 13 (20.0) 3 10 0.026 12 1 0.809
  Arthralgia 7 (10.8) 0 7 0.007 7 0 0.301
Subjects experiencing ADE (%) 48 (73.8) 17 (54.8) 31 (91.2) <0.001 48 (84.2) 4 (50.0) 0.077

Values are presented as number (%).

Abbreviation: ADE, adverse drug event.

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