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Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study.

Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z - Springerplus (2014)

Bottom Line: Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively.Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively.These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants. NCT01494740.

View Article: PubMed Central - PubMed

Affiliation: Shanghai Institute of Biological Products, Shanghai, 200052 China.

ABSTRACT

Abstract: The aim of this study is to further investigate the immune response of the inactivated split-virion vaccine for infants. We tested the immunogenicity and safety of the inactivated split-virion vaccine in infants, aged 6-35 months, for a randomized, observer-masked, age-stratified clinical study. We randomly divided subjects into three groups: 7.5 μg, 15 μg of hemagglutinin antigen dosage groups and seasonal influenza vaccine for children dosage group in a 2 dose regimen. A serologic analysis was performed at baseline and on day 21 and 42. 312 infants received a single dose injection of vaccine and 265 (84.94%) infants received two doses injection of vaccine. Adverse reactions were mostly mild or moderate. Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively. Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively. These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants.

Clinical trials registration: NCT01494740.

No MeSH data available.


Related in: MedlinePlus

Reactogenicity in all subjects: the total adverse reaction rates within 7 days after each vaccine dose.
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Fig1: Reactogenicity in all subjects: the total adverse reaction rates within 7 days after each vaccine dose.

Mentions: The overall adverse reaction rates are shown in Figure 1. After one dose of injection, the 7.5 μg group had a mild adverse reaction rate of 10.83% and the moderate adverse reaction rate of 6.67%. The 15 μg group had a mild adverse reaction rate of 10.83% and the moderate adverse reaction rate of 8.33%. The SI group had a mild adverse reaction rate of 6.25% and the moderate adverse reaction rate of 6.25%. In all groups, no serious adverse reactions were detected. Fever was the most frequently reported adverse effect. After one dose of injection, the fever reaction rate in the 7.5 μg, 15 μg and SI group were 11.67%, 13.33% and 9.72%, respectively. After two doses of injection, the fever reaction rate in the 7.5 μg, 15 μg and SI group were 14.42%, 15.46% and 12.50%, respectively. In addition to fever, eating disorders, vomiting, diarrhea, coughing, crying and other adverse reactions have occurred in the study dose group. Except for vomiting, other adverse reactions have occurred in the SI.Figure 1


Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study.

Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z - Springerplus (2014)

Reactogenicity in all subjects: the total adverse reaction rates within 7 days after each vaccine dose.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4125604&req=5

Fig1: Reactogenicity in all subjects: the total adverse reaction rates within 7 days after each vaccine dose.
Mentions: The overall adverse reaction rates are shown in Figure 1. After one dose of injection, the 7.5 μg group had a mild adverse reaction rate of 10.83% and the moderate adverse reaction rate of 6.67%. The 15 μg group had a mild adverse reaction rate of 10.83% and the moderate adverse reaction rate of 8.33%. The SI group had a mild adverse reaction rate of 6.25% and the moderate adverse reaction rate of 6.25%. In all groups, no serious adverse reactions were detected. Fever was the most frequently reported adverse effect. After one dose of injection, the fever reaction rate in the 7.5 μg, 15 μg and SI group were 11.67%, 13.33% and 9.72%, respectively. After two doses of injection, the fever reaction rate in the 7.5 μg, 15 μg and SI group were 14.42%, 15.46% and 12.50%, respectively. In addition to fever, eating disorders, vomiting, diarrhea, coughing, crying and other adverse reactions have occurred in the study dose group. Except for vomiting, other adverse reactions have occurred in the SI.Figure 1

Bottom Line: Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively.Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively.These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants. NCT01494740.

View Article: PubMed Central - PubMed

Affiliation: Shanghai Institute of Biological Products, Shanghai, 200052 China.

ABSTRACT

Abstract: The aim of this study is to further investigate the immune response of the inactivated split-virion vaccine for infants. We tested the immunogenicity and safety of the inactivated split-virion vaccine in infants, aged 6-35 months, for a randomized, observer-masked, age-stratified clinical study. We randomly divided subjects into three groups: 7.5 μg, 15 μg of hemagglutinin antigen dosage groups and seasonal influenza vaccine for children dosage group in a 2 dose regimen. A serologic analysis was performed at baseline and on day 21 and 42. 312 infants received a single dose injection of vaccine and 265 (84.94%) infants received two doses injection of vaccine. Adverse reactions were mostly mild or moderate. Among the subjects who received 7.5 μg and 15 μg of vaccine for a single dose injection, the rate of hemagglutinin inhibition titer of 1:40 or greater were 52.48% (95% confidence interval (CI) 42.83 ~ 61.95) and 61.11% (95% CI 50.78 ~ 70.53), respectively. Among the subjects receiving 7.5 μg and 15 μg of vaccine for two doses injection, the rate of hemagglutinin inhibition (HI) titer of 1:40 or greater were 90.10% (95% CI 82.73 ~ 94.53) and 94.44% (95% CI 87.64 ~ 97.60), respectively. These data suggests that 15 μg or 7.5 μg dose of hemagglutinin antigen of the inactivated split-virion vaccine was safe and two doses of injection could induce a sufficient protective immune response in infants.

Clinical trials registration: NCT01494740.

No MeSH data available.


Related in: MedlinePlus