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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,507
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
Centro de Salud Galvan
Santo Domingo, Dominican Republic
Hosp. Nuestra Sra. Altagracia
Santo Domingo, Dominican Republic
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.
Time frame: 21 days after vaccination
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.
Time frame: 21 days after vaccination
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.
Time frame: 7 days after vaccination
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).
Time frame: 3 weeks after vaccination
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%.
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1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Time frame: 21 days after vaccination
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%.
Time frame: 21 days after vaccination
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%.
Time frame: 21 days after vaccination