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OpenTrials
Completed

NCT Number: NCT02256488

Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).

The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.

The total study participation time per subject is about 3 weeks.

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Key information

Conditions

Prophylaxis: Influenza

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anaheim Clincial Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or females 18 through 49 years of age.
  • Subjects having provided informed consent.
  • Individuals in good health

Exclusion criteria

  • Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
  • Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.

Treatment and study plan

TIVc_LOT A

Biological

Single IM (Intramuscular) administration dose of 0.5 mL of TIVc

TIVc_LOT B

Biological

Single IM administration dose of 0.5 mL of TIVc

TIVc_LOT C

Biological

Single IM administration dose of 0.5 mL of TIVc

TIVf

Biological

Single IM administration dose of 0.5 mL of TIVf

Primary outcomes

  1. Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.

    Time frame: Day 22

    Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.

Secondary outcomes

  1. Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.

    Time frame: Day 22

    Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).

    Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.

    HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.

    According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.

  2. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf

    Time frame: Day 1 through day 7 (without 30 min)

    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.

  3. Number of Subjects With Unsolicited Adverse Events

    Time frame: Day 1 through day 22

    Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2014
Registry last updated
Jun 11, 2019

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.