Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617851
• Other study ID #: V71P6
• Secondary ID: 13299
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2008
• Last updated: May 3, 2012
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRepublica Dominicana: SESPIOSRepublica Dominicana: CONABIOS
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: June 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Lot A of Influenza virus vaccine
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
• Lot B of Influenza virus vaccine
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
• Lot C of Influenza virus vaccine
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
• Comparator influenza virus vaccine
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
• All 3 consecutive lots of influenza virus vaccine pooled
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Locations

Country	Name	City	State
Dominican Republic	Centro de Salud Galvan	Santo Domingo
Dominican Republic	Hosp. Nuestra Sra. Altagracia	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 days after vaccination	No
Secondary	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.	21 days after vaccination	No
Secondary	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.	7 days after vaccination	Yes
Secondary	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).	3 weeks after vaccination	Yes
Secondary	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%.	21 days after vaccination	No
Secondary	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%.	21 days after vaccination	No
Secondary	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%.	21 days after vaccination	No