The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Shanghai Institute Of Biological Products.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Shanghai Institute Of Biological Products
Information provided by:
Shanghai Institute Of Biological Products
ClinicalTrials.gov Identifier:
NCT01336166
First received: April 7, 2011
Last updated: April 14, 2011
Last verified: April 2011
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Purpose
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg Biological: Placebo control |
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 |
Resource links provided by NLM:
Further study details as provided by Shanghai Institute Of Biological Products:
Primary Outcome Measures:
- Hemagglutination inhibition antibody titer [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- occurrence of solicited local and systemic adverse events after vaccination [ Time Frame: Days 0-42 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 480 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: split-virion, non-adjuvanted vaccine of 15 μg
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
|
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
|
|
Experimental: split-virion, non-adjuvanted vaccine of 30 μg
split-virion, non-adjuvanted H1N1 vaccine of 30 μg.
|
Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg
120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
|
|
Experimental: split-virion, non-adjuvanted vaccine of 45 μg
split-virion, non-adjuvanted H1N1 vaccine of 45 μg.
|
Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg
120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
|
|
Placebo Comparator: Placebo control
Placebo control
|
Biological: Placebo control
120 adults were assigned to receive 1 dose of placebo.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
- Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
- Requests of clinical research program can be obeyed
- No other protective product is inoculated in last week
- Axillary temperature below 37 degrees Celsius
Exclusion Criteria:
- Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- History of progressive or severe neurologic disorder
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- Guillain-Barre Syndrome
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
- Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
- Any conditions may influence the evaluation
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ze Chen, Shanghai Institute of Biological Products |
| ClinicalTrials.gov Identifier: | NCT01336166 History of Changes |
| Other Study ID Numbers: | SIBP-2009 |
| Study First Received: | April 7, 2011 |
| Last Updated: | April 14, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shanghai Institute Of Biological Products:
|
H1N1 Vaccine Immunogenicity Safety |
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 16, 2013