Abstract
A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-microg whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-microg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-microg split-virion formulation had the best immunogenicity and safety.
Trial registration:
ClinicalTrials.gov NCT00956111.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic* / administration & dosage
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Adjuvants, Immunologic* / adverse effects
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Adolescent
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Adult
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Aluminum Hydroxide* / administration & dosage
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Aluminum Hydroxide* / adverse effects
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Aluminum Hydroxide* / immunology
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Antibodies, Viral / blood*
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Double-Blind Method
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Humans
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Influenza A Virus, H1N1 Subtype / immunology*
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Influenza Vaccines / administration & dosage
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Influenza Vaccines / adverse effects
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Influenza Vaccines / immunology*
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Influenza, Human / immunology
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Influenza, Human / prevention & control*
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Influenza, Human / virology
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Logistic Models
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Middle Aged
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Time Factors
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Treatment Outcome
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Virion / immunology
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Young Adult
Substances
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Adjuvants, Immunologic
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Antibodies, Viral
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Influenza Vaccines
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Aluminum Hydroxide
Associated data
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ClinicalTrials.gov/NCT00956111