Back to resultsStudy to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
Lot A of Influenza virus vaccine
Lot B of Influenza virus vaccine
Lot C of Influenza virus vaccine
Comparator influenza virus vaccine
All 3 consecutive lots of influenza virus vaccine pooled
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, adults, different lots, trivalent subunit influenza virus vaccine (IVV), trivalent subunit influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- 18 to 49 years of age;
- In good health as determined by medical history and physical examination;
- Able and willing to provide written informed consent prior to any study procedure;
- Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Exclusion Criteria:
- Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- Known or suspected impairment/alteration of immune function
- Receipt of an influenza vaccine within 6 months prior to Visit 1;
- Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Sites / Locations
- Centro de Salud Galvan
- Hosp. Nuestra Sra. Altagracia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Influenza virus vaccine (lot A)
Influenza virus vaccine (lot B)
Influenza virus vaccine (lot C)
Influenza virus vaccine (pooled)
Comparator influenza vaccine
Arm Description
Lot A of the investigational influenza virus vaccine
Lot B of the investigational influenza virus vaccine
Lot C of the investigational influenza virus vaccine
Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
A US licensed influenza virus vaccine
Outcomes
Primary Outcome Measures
Geometric Mean Titers (GMTs), by Vaccine Lots
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
Secondary Outcome Measures
Geometric Mean Titers (GMTs), by Vaccine Group and Strain
The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.
Number of Subjects Reporting Solicited Local and Systemic Symptoms
Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.
Number of Subjects With at Least One Unsolicited Adverse Event
Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Percentage of Subjects With Seroprotection and Seroconversion (Strain B)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00617851
Brief Title
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Official Title
A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, adults, different lots, trivalent subunit influenza virus vaccine (IVV), trivalent subunit influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1507 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza virus vaccine (lot A)
Arm Type
Experimental
Arm Description
Lot A of the investigational influenza virus vaccine
Arm Title
Influenza virus vaccine (lot B)
Arm Type
Experimental
Arm Description
Lot B of the investigational influenza virus vaccine
Arm Title
Influenza virus vaccine (lot C)
Arm Type
Experimental
Arm Description
Lot C of the investigational influenza virus vaccine
Arm Title
Influenza virus vaccine (pooled)
Arm Type
Experimental
Arm Description
Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
Arm Title
Comparator influenza vaccine
Arm Type
Active Comparator
Arm Description
A US licensed influenza virus vaccine
Intervention Type
Biological
Intervention Name(s)
Lot A of Influenza virus vaccine
Intervention Description
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Lot B of Influenza virus vaccine
Intervention Description
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Lot C of Influenza virus vaccine
Intervention Description
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Comparator influenza virus vaccine
Intervention Description
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
All 3 consecutive lots of influenza virus vaccine pooled
Intervention Description
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Primary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs), by Vaccine Lots
Description
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
Time Frame
21 days after vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs), by Vaccine Group and Strain
Description
The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.
Time Frame
21 days after vaccination
Title
Number of Subjects Reporting Solicited Local and Systemic Symptoms
Description
Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.
Time Frame
7 days after vaccination
Title
Number of Subjects With at Least One Unsolicited Adverse Event
Description
Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).
Time Frame
3 weeks after vaccination
Title
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
Description
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Time Frame
21 days after vaccination
Title
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
Description
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Time Frame
21 days after vaccination
Title
Percentage of Subjects With Seroprotection and Seroconversion (Strain B)
Description
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Time Frame
21 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 49 years of age;
In good health as determined by medical history and physical examination;
Able and willing to provide written informed consent prior to any study procedure;
Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Exclusion Criteria:
Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
Known or suspected impairment/alteration of immune function
Receipt of an influenza vaccine within 6 months prior to Visit 1;
Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Salud Galvan
City
Santo Domingo
Country
Dominican Republic
Facility Name
Hosp. Nuestra Sra. Altagracia
City
Santo Domingo
Country
Dominican Republic
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
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