This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
342
Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Instituto de Ensino e Pesquisa em Geriatria e Gerontologia
São Paulo, São Paulo, Brazil
Geometric Mean HI Titer by Visit
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Time frame: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)
Geometric Mean Ratio by Visit
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus).
Time frame: 13 months after vaccination (Day 22/Day1, Day 43/Day 1, Day 43/Day 22, Day 133/Day 43, Day 223/Day 43 and Day 403/Day 223)
Ratio of Immunogenicity Data by Visit (Vaccine With Adjuvant : Vaccine Without Adjuvant)
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using ratios of immunogenicity data and were presented with 95% confidence intervals.
Time frame: 13 months after vaccination (Day 1, Day 22, Day 22/Day1, Day 43, Day 43/Day 1, Day 43/Day 22, Day 133, Day 133/Day 43, Day 223, Day 223/Day 43 and Day 403, Day 403/Day 223)
Percentage of Subjects Who Reached Seroprotection by Visit
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). The percentage of subjects that reached seroprotection in comparison to the pre-vaccination result are presented by visit. Seroprotection was defined as HI titer ≥40.
Time frame: 13 months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Percent of Subjects Who Seroconverted or Had a Significant Increase in Geometric Mean Titer by Visit
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). The percentage of subjects that reached seroconversion or had a significant increase in comparison to the pre-vaccination result were presented by visit. Seroconversion or a significant increase was defined as HI titer ≥40 in subjects with negative results at pre-vaccination (HI titer \<10) or an increase of at least 4 times in HI titer for individuals with positive results at pre-vaccination (HI titer \>10) at Day 22 and Day 43 in comparison to the pre-vaccination result.
Time frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Difference in the Seroprotection Rates by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroprotection and were presented with 95% confidence intervals.
Time frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Differences in the Seroconversion Rates or Significant Increase by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.
Time frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
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