Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
- Conditions
- Influenza
- Interventions
- Biological: Lot A of Influenza virus vaccineBiological: Lot B of Influenza virus vaccineBiological: Lot C of Influenza virus vaccineBiological: All 3 consecutive lots of influenza virus vaccine pooledBiological: Comparator influenza virus vaccine
- Registration Number
- NCT00617851
- Lead Sponsor
- Novartis Vaccines
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1507
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Influenza virus vaccine (lot A) Lot A of Influenza virus vaccine Lot A of the investigational influenza virus vaccine Influenza virus vaccine (lot B) Lot B of Influenza virus vaccine Lot B of the investigational influenza virus vaccine Influenza virus vaccine (lot C) Lot C of Influenza virus vaccine Lot C of the investigational influenza virus vaccine Influenza virus vaccine (pooled) All 3 consecutive lots of influenza virus vaccine pooled Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine Comparator influenza vaccine Comparator influenza virus vaccine A US licensed influenza virus vaccine
- Primary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs), by Vaccine Lots 21 days after vaccination 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
Name Time Method Geometric Mean Titers (GMTs), by Vaccine Group and Strain 21 days after vaccination 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 7 days after vaccination 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 3 weeks after vaccination 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) 21 days after vaccination 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) 21 days after vaccination 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) 21 days after vaccination 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%.
Trial Locations
- Locations (2)
Centro de Salud Galvan
🇩🇴Santo Domingo, Dominican Republic
Hosp. Nuestra Sra. Altagracia
🇩🇴Santo Domingo, Dominican Republic