Phase 3
N=120
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02381418 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. — 96.6; 96.6; 93.2; 98.3 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trivalent influenza subunit vaccine Influvac (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. |
19.2; 8.6; 5.7; 12.2; 3.1; 2.7 | — |
| PRIMARY the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. |
19.2; 8.6; 5.7; 12.2; 3.1; 2.7 | — |
| SECONDARY Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®. |
6; 5; 4; 5; 22; 7 | — |
Summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged >= 18 and = 61 years of age (elderly).
Eligibility Criteria
Inclusion Criteria
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
- Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator
Exclusion Criteria
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination.
- Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
- A history of Guillain-Barré syndrome or active neurological disease.
Data sourced from ClinicalTrials.gov (NCT02381418). 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.