Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
This study has been completed.
Sponsor:
Abbott Biologicals
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT00889889
First received: April 28, 2009
Last updated: December 26, 2012
Last verified: December 2012
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Purpose
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza Vaccine Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years. |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Abbott:
Primary Outcome Measures:
- To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 1270 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
|
| Placebo Comparator: 2 |
Biological: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 <= 64 years.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria
- Known to be allergic to constituents 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.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889889
Locations
| United States, Florida | |
| Site Reference ID/Investigator# 45690 | |
| Jacksonville, Florida, United States, 32216 | |
| Site Reference ID/Investigator# 45687 | |
| Pembroke Pines, Florida, United States, 33024 | |
| Site Reference ID/Investigator# 45697 | |
| South Miami, Florida, United States, 33143 | |
| United States, Kansas | |
| Site Reference ID/Investigator# 45691 | |
| Lenexa, Kansas, United States, 66219 | |
| Site Reference ID/Investigator# 45689 | |
| Overland Park, Kansas, United States, 66212 | |
| Site Reference ID/Investigator# 45694 | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Site Reference ID/Investigator# 45682 | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 45684 | |
| Kansas City, Missouri, United States, 64114 | |
| United States, Nebraska | |
| Site Reference ID/Investigator# 45685 | |
| Omaha, Nebraska, United States, 68134 | |
| United States, Nevada | |
| Site Reference ID/Investigator# 45686 | |
| Las Vegas, Nevada, United States, 89104 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 45688 | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Tennessee | |
| Site Reference ID/Investigator# 45696 | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Site Reference ID/Investigator# 45683 | |
| Austin, Texas, United States, 78705 | |
| Site Reference ID/Investigator# 45695 | |
| Fort Worth, Texas, United States, 76135 | |
| United States, Utah | |
| Site Reference ID/Investigator# 45692 | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
Abbott Biologicals
Quintiles
Investigators
| Study Director: | Hanka de Voogd, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott ( Abbott Biologicals ) |
| ClinicalTrials.gov Identifier: | NCT00889889 History of Changes |
| Other Study ID Numbers: | S203.2.004 |
| Study First Received: | April 28, 2009 |
| Last Updated: | December 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Influenza Phase II Placebo-controlled |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013