Trial record 3 of 12 for:
Open Studies | "Influenza in Birds"
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults
This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Novartis Vaccines
Collaborator:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01776541
First received: January 20, 2013
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic H5N1 Influenza |
Biological: Adjuvanted H5N1 pandemic influenza vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Phase II, Randomized, Observer-Blind With Single-Blind Booster, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Adult Subjects. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To select a vaccine dose based on the achievement of CBER criteria for further development [ Time Frame: Day 43 (3 weeks after second vaccination) ] [ Designated as safety issue: No ]Seroprotection and Seroconversion rate measured 3 weeks after second dose of vaccine administration
- Percentage of subjects with solicited local and systemic adverse events [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]
- Percentage of subjects with unsolicited adverse events [ Time Frame: 3 weeks post vaccination ] [ Designated as safety issue: Yes ]
- Percentage of subjects with serious adverse events, medically attended adverse events, adverse events leading to withdrawal and adverse events of special interest [ Time Frame: Day 1 through Day 732 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Achievement of CHMP criteria 3 weeks after after second dose of vaccine administration [ Time Frame: Day 43 ] [ Designated as safety issue: No ]Seroprotection, Seroconversion rate and GMRs measured 3 weeks after second dose of vaccine administration
- Achievement of CBER and CHMP criteria 3 weeks after first dose of vaccine administration [ Time Frame: Day 22 ] [ Designated as safety issue: No ]Seroprotection, Seroconversion rate and GMRs measured 3 weeks after first dose of vaccine administration
- Achievement of CBER and CHMP criteria 3 weeks after booster dose of vaccine administration [ Time Frame: Day 387 ] [ Designated as safety issue: No ]Seroprotection, Seroconversion rate and GMRs measured 3 weeks after booster dose of vaccine administration
| Estimated Enrollment: | 972 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: aH5N1c-High Dose |
Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
|
| Experimental: aH5N1c-Low dose |
Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adult subjects 18 to 64 years of age,
- Individuals willing to provide written informed consent,
- Individuals in good health,
- Individuals willing to allow for their serum samples to be stored beyond the study period.
Exclusion Criteria:
- Individuals not able to understand and follow study procedures,
- History of any significant illness,
- History of any chronic medical condition or progressive disease,
- Presence of medically significant cancer,
- Known or suspected impairment/alteration of immune function,
- Presence of any progressive or severe neurologic disorder,
- Presence of any bleeding disorders or conditions that prolongs bleeding time,
- History of allergy to vaccine components,
- Receipt of any other investigational product within 30 days prior to entry into the study,
- History of previous H5N1 vaccination,
- Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
- Receipt of any other vaccine within 2 weeks prior to entry into the study
- Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
- Pregnant or breast feeding,
- Females of childbearing potential refusing to use acceptable method of birth control,
- Body mass index (BMI) ≥ 35 kg/m2,
- History of drug or alcohol abuse,
- Any planned surgery during study period,
- Individuals conducting the study and their immediate family members,
- Individuals with behavioral or cognitive impairment or psychiatric diseases.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776541
Contacts
| Contact: Novartis Drug Information Services | +1 800 244 7668 |
Locations
| United States, Florida | |
| Recruiting | |
| South Miami, Florida, United States, 33143 | |
| United States, Missouri | |
| Recruiting | |
| St Louis, Missouri, United States, 63104 | |
| Recruiting | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States, 78705 | |
| Australia, New South Wales | |
| Recruiting | |
| Broadmeadow, New South Wales, Australia, 2292 | |
| Australia, South Australia | |
| Recruiting | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Western Australia | |
| Recruiting | |
| Nedlands, Western Australia, Australia, 6009 | |
| Thailand | |
| Recruiting | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines and Diagnostics | Novartis Vaccines |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01776541 History of Changes |
| Other Study ID Numbers: | V89_04 |
| Study First Received: | January 20, 2013 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Food and Drug Administration Thailand: Food and Drug Administration Australia: Therapeutic Goods Administration |
Keywords provided by Novartis:
|
Influenza, Pandemic, H5N1, Adults |
Additional relevant MeSH terms:
|
Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013