Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
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
2 other identifiers
interventional
1,507
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2007
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 6, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
June 24, 2010
CompletedMay 8, 2012
May 1, 2012
1 month
February 6, 2008
February 3, 2010
May 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Geometric Mean Titers (GMTs), by Vaccine Group and Strain
21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms
7 days after vaccination
Number of Subjects With at Least One Unsolicited Adverse Event
3 weeks after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
21 days after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
21 days after vaccination
- +1 more secondary outcomes
Study Arms (5)
Influenza virus vaccine (lot A)
EXPERIMENTALLot A of the investigational influenza virus vaccine
Influenza virus vaccine (lot B)
EXPERIMENTALLot B of the investigational influenza virus vaccine
Influenza virus vaccine (lot C)
EXPERIMENTALLot C of the investigational influenza virus vaccine
Influenza virus vaccine (pooled)
EXPERIMENTALPooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
Comparator influenza vaccine
ACTIVE COMPARATORA US licensed influenza virus vaccine
Interventions
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
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centro de Salud Galvan
Santo Domingo, Dominican Republic
Hosp. Nuestra Sra. Altagracia
Santo Domingo, Dominican Republic
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY DIRECTOR
Novartis Vaccines and Diagnostics
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2008
First Posted
February 18, 2008
Study Start
November 1, 2007
Primary Completion
December 1, 2007
Study Completion
June 1, 2008
Last Updated
May 8, 2012
Results First Posted
June 24, 2010
Record last verified: 2012-05