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

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Lot A of Influenza virus vaccine Biological: Lot B of Influenza virus vaccine Biological: Lot C of Influenza virus vaccine Biological: Comparator influenza virus vaccine Biological: All 3 consecutive lots of influenza virus vaccine pooled	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Geometric Mean Titers (GMTs), by Vaccine Lots [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: 7 days after vaccination ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 weeks after vaccination ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
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) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
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) [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
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%.

Enrollment:	1507
Study Start Date:	November 2007
Study Completion Date:	June 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Influenza virus vaccine (lot A) Lot A of the investigational influenza virus vaccine	Biological: Lot A of Influenza virus vaccine 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
Experimental: Influenza virus vaccine (lot B) Lot B of the investigational influenza virus vaccine	Biological: Lot B of Influenza virus vaccine 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
Experimental: Influenza virus vaccine (lot C) Lot C of the investigational influenza virus vaccine	Biological: Lot C of Influenza virus vaccine 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
Experimental: Influenza virus vaccine (pooled) Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine	Biological: All 3 consecutive lots of influenza virus vaccine pooled 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Active Comparator: Comparator influenza vaccine A US licensed influenza virus vaccine	Biological: Comparator influenza virus vaccine 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617851

Locations

Dominican Republic
Centro de Salud Galvan
Santo Domingo, Dominican Republic
Hosp. Nuestra Sra. Altagracia
Santo Domingo, Dominican Republic

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines and Diagnostics

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00617851 History of Changes
Other Study ID Numbers:	V71P6, 13299
Study First Received:	February 6, 2008
Results First Received:	February 3, 2010
Last Updated:	May 3, 2012
Health Authority:	United States: Food and Drug Administration Republica Dominicana: SESPIOS Republica Dominicana: CONABIOS

Keywords provided by Novartis:

Influenza
adults
different lots
trivalent subunit influenza virus vaccine (IVV)
trivalent subunit influenza vaccine

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013