Clinical trial NCT00617851: Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
adults
different lots
trivalent subunit influenza virus vaccine (IVV)
trivalent subunit influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 1507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Titers (GMTs), by Vaccine Lots
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs), by Vaccine Group and Strain
timeFrame: 21 days after vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Symptoms
timeFrame: 7 days after vaccination
measure: Number of Subjects With at Least One Unsolicited Adverse Event
timeFrame: 3 weeks after vaccination
measure: Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
timeFrame: 21 days after vaccination
measure: Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
timeFrame: 21 days after vaccination
measure: Percentage of Subjects With Seroprotection and Seroconversion (Strain B)
timeFrame: 21 days after vaccination
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Centro de Salud Galvan
city: Santo Domingo
country: Dominican Republic
facility: Hosp. Nuestra Sra. Altagracia
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References: