CompletedPhase 3

Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

Brazil342 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. 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 sexual intercourse
✓. Intra-uterine device (IUD)
✓. Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study)

What they're measuring

Geometric Mean HI Titer by Visit

Timeframe: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)

Geometric Mean Ratio by Visit

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Trial details

NCT IDNCT01032395

SponsorChiltern Pesquisa Clinica Ltda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More H1N1 Influenza Virus trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)
✓. 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 sexual intercourse
✓. Intra-uterine device (IUD)
✓. Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study)

What they're measuring

Geometric Mean HI Titer by Visit

Timeframe: 13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)

Geometric Mean Ratio by Visit

Timeframe: 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)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)