| 1 |
NCT00938639 |
Completed
Has Results |
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults |
- Influenza Caused by the Novel Influenza A (H1N1) Virus
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
- HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
- Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
- (and 23 more...)
|
240 |
All |
18 Years to 64 Years (Adult) |
NCT00938639 |
CSLCT-CAL-09-59 |
|
July 2009 |
September 2009 |
March 2010 |
July 14, 2009 |
June 28, 2018 |
November 21, 2013 |
- Study Site
Adelaide, South Australia, Australia
|
|
| 2 |
NCT01055184 |
Completed
Has Results |
Effects of Age on Response to the 2009 H1N1 Virus Vaccine |
- 2009 H1N1 Influenza Virus
|
- Biological: 2009 H1N1 Virus Vaccine
|
Interventional
|
Phase 1
Phase 2 |
- University of Rochester
- National Institutes of Health (NIH)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Who Shed Virus
|
34 |
All |
60 Years and older (Adult, Older Adult) |
NCT01055184 |
URMC 09-009 |
|
March 2010 |
April 2011 |
|
January 25, 2010 |
May 30, 2016 |
May 30, 2016 |
- University of Rochester Medical Center, Vaccine Research Unit
Rochester, New York, United States
|
|
| 3 |
NCT01394640 |
Completed |
Immunologic Response After Pandemic Influenza A (H1N1) Vaccine in Onco- Hematologic Patients |
- Lymphoma
- Multiple Myeloma
- Myeloproliferative Disease
|
- Biological: Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus
|
Observational
|
|
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- University of Milan
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To assess antibody response (antibody titer > 1:40 or four-fold increase, geometric mean titer) in onco-hematologic patients and controls and whether this response changes over time
- To assess virus specific cell mediated response (by flow-cytometry evaluation) in onco-hematologic patients and controls and whether this response changes over time.
- To assess whether controls or patients develop influenza like illness or symptoms.
|
124 |
All |
18 Years and older (Adult, Older Adult) |
NCT01394640 |
INT 72/09 |
|
October 2009 |
May 2010 |
January 2011 |
July 14, 2011 |
August 1, 2011 |
|
- Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
|
|
| 4 |
NCT01055990 |
Unknown † |
Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients |
- Virus Diseases
- Respiratory Tract Diseases
- Respiratory Tract Infections
- (and 2 more...)
|
- Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
- Other: blood fix
|
Interventional
|
Phase 2 |
- Shanghai Public Health Clinical Center
- Beijing Ditan Hospital
- National Institute for the Control of Pharmaceutical and Biological Products, China
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- apply blood fix to treat critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1
- Hemagglutination inhibition antibody titer and Microneutralization antibody titer
- local and systemic adverse reaction after vaccination
|
7 |
All |
18 Years to 60 Years (Adult) |
NCT01055990 |
NCT-0015 |
|
October 2009 |
April 2010 |
May 2010 |
January 26, 2010 |
January 26, 2010 |
|
- Shanghai Public Health Clinical Center
Shanghai, Shanghai, China
|
|
| 5 |
NCT01016548 |
Completed |
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy |
- Lymphoma
- Multiple Myeloma
- Influenza A Virus, H1N1 Subtype
|
- Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine
|
Interventional
|
Phase 3 |
- University Health Network, Toronto
- Princess Margaret Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Seroconversion rates.
- Adverse events to vaccination.
|
42 |
All |
20 Years to 65 Years (Adult, Older Adult) |
NCT01016548 |
09-0780-C
INVC-2009-0241 |
|
November 2009 |
March 2010 |
June 2010 |
November 19, 2009 |
June 4, 2010 |
|
- Princess Margaret Hospital
Toronto, Ontario, Canada
|
|
| 6 |
NCT01246999 |
Completed
Has Results |
Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children |
|
- Biological: Live attenuated Influenza vaccine
- Biological: Trivalent Influenza Vaccine
- Biological: TIV followed by LAIV
- Biological: LAIV followed by TIV
|
Interventional
|
Phase 4 |
- University of Rochester
- National Institutes of Health (NIH)
- Dartmouth-Hitchcock Medical Center
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR
- Mean Peak H1N1 Virus Titer, Dose 1
- Mean Peak H3N2 Virus Titer, Dose 1
- (and 4 more...)
|
34 |
All |
2 Years to 9 Years (Child) |
NCT01246999 |
URMC10-005/Dartmouth 22164 |
|
October 2010 |
January 2013 |
June 2013 |
November 24, 2010 |
December 29, 2016 |
October 19, 2016 |
- Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States - Vaccine Research Unit Room 3-5000
Rochester, New York, United States
|
|
| 7 |
NCT01097941 |
Withdrawn |
Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children |
|
- Biological: Live Attenuated H1N1 Influenza Vaccine
- Biological: Influenza A (H1N1) 2009 Monovalent Vaccine
- Biological: Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live
|
Interventional
|
Phase 4 |
- University of Rochester
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
- The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
- The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
- (and 3 more...)
|
0 |
All |
4 Years to 9 Years (Child) |
NCT01097941 |
URMC 09-007 |
H1N1Children |
March 2010 |
September 2010 |
September 2010 |
April 2, 2010 |
September 24, 2015 |
|
- University of Rochester Medical Center, Vaccine Research Unit Room 3-5000
Rochester, New York, United States
|
|
| 8 |
NCT01916759 |
Completed |
Differences in Response to the Flu Vaccine Among Adults With HIV and Without HIV in Uganda |
- HIV
- Acquired Immunodeficiency Syndrome
- Influenza
|
- Drug: Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)
|
Interventional
|
Not Applicable |
- Emory University
- Makerere University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- In group and between group comparison of immune parameters and gene expressions that change significantly following vaccination with the seasonal trivalent influenza vaccine (Vaxigrip®)
- Proportion of subjects achieving 4-fold or greater hemagglutination inhibition (HAI)antibody titer increases.
- Calculating correlation coefficient between the immune parameter and vaccine immunogenicity, as measured by the humoral immune response against seasonal influenza.
- (and 2 more...)
|
63 |
All |
18 Years and older (Adult, Older Adult) |
NCT01916759 |
IRB00058919
1U19AI090023-02 |
|
June 2013 |
December 2013 |
March 2014 |
August 6, 2013 |
April 23, 2014 |
|
- Makere University- Johns Hopkins University Research Collaboration, at the Mulago National Referral Hospital
Kampala, Uganda
|
|
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