Phase 3
Completed N=1,200
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
| Outcome | Result | p-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.
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.