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Completed

NCT Number: NCT00617851

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Salud Galvan, Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lot A of Influenza virus vaccine

Biological

1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly

Lot B of Influenza virus vaccine

Biological

1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly

Lot C of Influenza virus vaccine

Biological

1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly

Comparator influenza virus vaccine

Biological

1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly

All 3 consecutive lots of influenza virus vaccine pooled

Biological

1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Primary outcomes

  1. Geometric Mean Titers (GMTs), by Vaccine Lots

    Time frame: 21 days after vaccination

    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 outcomes

  1. Geometric Mean Titers (GMTs), by Vaccine Group and Strain

    Time frame: 21 days after vaccination

    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.

  2. Number of Subjects Reporting Solicited Local and Systemic Symptoms

    Time frame: 7 days after vaccination

    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.

  3. Number of Subjects With at Least One Unsolicited Adverse Event

    Time frame: 3 weeks after vaccination

    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).

  4. Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)

    Time frame: 21 days after vaccination

    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%.

  5. Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)

    Time frame: 21 days after vaccination

    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%.

  6. Percentage of Subjects With Seroprotection and Seroconversion (Strain B)

    Time frame: 21 days after vaccination

    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%.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Feb 18, 2008
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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