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Phase 3 Completed N=1,200 Randomized Single-blind Prevention

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

Source: ClinicalTrials.gov NCT00310804 ↗
Enrolled (actual)
1,200
Serious AEs
2.6%
Results posted
Jan 2013
Primary outcomePrimary: Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects — 12; 15; 16; 14 Titers

Summary

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
12; 15; 16; 14; 15; 175
PRIMARY
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
20; 18; 18; 18; 15; 14
PRIMARY
Percentage of Subjects With HI Titers ≥40
36; 38; 34; 36; 38; 97
PRIMARY
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
80; 81; 82; 81; 76; 84
SECONDARY
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
57; 40; 37; 134; 16; 6
SECONDARY
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
74; 62; 13; 6; 45; 1

Eligibility Criteria

Inclusion Criteria

  • 18 to <61 years of age
  • mentally competent to understand the nature, the scope and the consequences of the study
  • able and willing to give written informed consent prior to study entry
  • in good health as determined by:
  • medical history,
  • physical examination,
  • clinical judgment of the Investigator.

Exclusion Criteria

  • unwilling or unable to give written informed consent to participate in the study
  • participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  • currently experiencing an acute infectious disease
  • any serious disease, such as, for example:
  • cancer,
  • autoimmune disease (including rheumatoid arthritis),
  • advanced arteriosclerotic disease or complicated diabetes mellitus,
  • chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
  • acute or progressive hepatic disease,
  • acute or progressive renal disease,
  • congestive heart failure
  • surgery planned during the study period
  • bleeding diathesis
  • history of hypersensitivity to any component of the study medication or chemically related substances
  • history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  • known or suspected impairment/alteration of immune function, for example resulting from:
  • receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
  • receipt of immunostimulants,
  • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
  • high risk for developing an immunocompromising disease
  • history of drug or alcohol abuse
  • laboratory-confirmed influenza disease within 6 months prior to Visit 1
  • receipt of influenza vaccine within 6 months prior to Visit 1
  • receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  • any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  • if female, pregnant or breastfeeding
  • if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  • planned relocation abroad during the study period
  • any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00310804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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