A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- H1N1 Influenza Virus
- Sponsor
- Chiltern Pesquisa Clinica Ltda
- Enrollment
- 342
- Locations
- 2
- Primary Endpoint
- Geometric Mean HI Titer by Visit
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Subjects with Chronic Diseases:
- •Subjects between 18 and 70 years of age (inclusive)
- •Any sex or ethnicity
- •Outpatient or hospitalized subjects
- •Confirmed diagnosis of chronic pulmonary and/or cardiac, and/or diabetes mellitus based on the investigator's assessment (subjects may present one or more of such conditions)
- •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
- •Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
- •Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
- •Intra-uterine device (IUD)
- •Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study)
Exclusion Criteria
- •For Subjects with Chronic Diseases
- •Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
- •Administration of other vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
- •Any recent vaccine given within the last 21 days (inclusive)
- •History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
- •Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
- •History of cancer, except for skin cancer, including Kaposi's Sarcoma, basal cell carcinoma, and non-invasive malignancy related to HPV
- •History of chronic hepatic or renal disease
- •History of cognitive disorders
- •History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
Outcomes
Primary Outcomes
Geometric Mean HI Titer by Visit
Time Frame: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Geometric Mean Ratio by Visit
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)
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).
Ratio of Immunogenicity Data by Visit (Vaccine With Adjuvant : Vaccine Without Adjuvant)
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)
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.
Percentage of Subjects Who Reached Seroprotection by Visit
Time Frame: 13 months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
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.
Percent of Subjects Who Seroconverted or Had a Significant Increase in Geometric Mean Titer by Visit
Time Frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
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.
Difference in the Seroprotection Rates by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
Time Frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
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.
Differences in the Seroconversion Rates or Significant Increase by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
Time Frame: 13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
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.