ABSTRACT
BACKGROUND: The morbidity and mortality associated with influenza is substantial in children with asthma. There are no available data on the safety and immunogenicity of influenza vaccine in children with asthma in Latin America. Furthermore, it is unclear if influenza vaccination may cause asthma exacerbations. METHODS: We conducted a placebo-controlled trial to investigate the safety and immunogenicity of an inactivated trivalent split virus influenza vaccine in children with asthma in Mexico. We also measured the impact of influenza vaccination on pulmonary function tests in this population. RESULTS: The inactivated influenza vaccine was immunogenic and safe in terms of local and systemic side effects compared to placebo. We observed no significant impact on pulmonary function tests among vaccine recipients. CONCLUSIONS: Given the significant morbidity associated with influenza in children, strategies to promote increased influenza vaccination coverage in this high-risk group in Latin America and elsewhere are urgently needed.
Subject(s)
Asthma/immunology , Influenza Vaccines/standards , Vaccines, Inactivated/standards , Asthma/chemically induced , Child , Child, Preschool , Double-Blind Method , Female , Humans , Influenza Vaccines/adverse effects , Influenza Vaccines/immunology , Male , Mexico , Placebos , Respiratory Function Tests , Safety , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/immunologyABSTRACT
In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripe) or sub-unit (Agrippal S1) influenza vaccine (1999-2000 formulations). For analysis, study groups were subdivided into adult (18-60 years old) and elderly (over 60 years) subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well tolerated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripe induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% of elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1. In conclusion, the split-virion and sub-unit influenza vaccines had similar safety and reactogenicity profiles, and elicited satisfactory immunity in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT) values in response to the B strain were seen with the split vaccine Imovax Gripe, giving it a better overall immunogenicity.
Subject(s)
Influenza Vaccines/immunology , Influenza, Human/prevention & control , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Viral/blood , Female , Humans , Influenza B virus/immunology , Influenza Vaccines/adverse effects , Male , Middle Aged , Single-Blind Method , Vaccination/methods , Vaccines, Subunit/adverse effects , Vaccines, Subunit/immunologyABSTRACT
In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripe) or sub-unit (Agripal S1) influenza vaccine (1999-2000 formulations). For analysis, study groups were subdivided into adult (18-60 years old) and elderly (over 60 years) subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well torelated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripe induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% od elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1. In conclusion, the split-virion and sub-unit influenza had similar safety and reactogenicity profiles, and elicited satisfactory immunuty in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT) values in response to the B strain were seen with the split vaccine Imovax Gripe, giving it a better overall immunogenicity.(AU)
Subject(s)
Comparative Study , Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Influenza, Human/prevention & control , Influenza Vaccines/immunology , Aged, 80 and over , Antibodies, Viral/blood , Influenza B virus/immunology , Influenza Vaccines/adverse effects , Single-Blind Method , Vaccination/methodsABSTRACT
In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripe) or sub-unit (Agripal S1) influenza vaccine (1999-2000 formulations). For analysis, study groups were subdivided into adult (18-60 years old) and elderly (over 60 years) subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well torelated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripe induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% od elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1. In conclusion, the split-virion and sub-unit influenza had similar safety and reactogenicity profiles, and elicited satisfactory immunuty in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT) values in response to the B strain were seen with the split vaccine Imovax Gripe, giving it a better overall immunogenicity.
