Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GQM09
Previous Study | Return to List | Next Study

Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01967784
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
Enrollment 100
Recruitment Details Study participants were enrolled from 18 October 2013 to 19 November 2013 at 2 clinical sites in Taiwan.
Pre-assignment Details A total of 100 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
100
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 100 participants
13.4  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
46
  46.0%
Male
54
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 100 participants
100
1.Primary Outcome
Title Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Hide Description Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were analyzed in the Immunogenicity Analysis Set.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description:
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Participants Analyzed 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
A/California/07/2009 (H1N1); Pre-dose
257
(204 to 324)
A/California/07/2009 (H1N1); Post-dose
589
(498 to 697)
A/Texas/50/2012 (H3N2); Pre-dose
382
(301 to 484)
A/Texas/50/2012 (H3N2); Post-dose
782
(649 to 944)
B/Massachusetts/2/2012; Pre-dose
497
(366 to 674)
B/Massachusetts/2/2012; Post-dose
1654
(1352 to 2024)
B/Brisbane/60/2008; Pre-dose
186
(139 to 250)
B/Brisbane/60/2008; Post-dose
856
(702 to 1045)
2.Primary Outcome
Title Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Hide Description Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was analyzed in the Immunogenicity Analysis Set.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description:
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Percentage of participants
A/California/07/2009 (H1N1); Pre-dose 95.0
A/California/07/2009 (H1N1); Post-dose 100.0
A/Texas/50/2012 (H3N2); Pre-dose 97.0
A/Texas/50/2012 (H3N2); Post-dose 99.0
B/Massachusetts/2/2012; Pre-dose 94.0
B/Massachusetts/2/2012; Post-dose 100.0
B/Brisbane/60/2008; Pre-dose 85.0
B/Brisbane/60/2008; Post-dose 100.0
3.Primary Outcome
Title Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
Hide Description Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description:
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Percentage of participants
A/California/07/2009 (H1N1) 24.0
A/Texas/50/2012 (H3N2) 20.0
B/Massachusetts/2/2012 39.0
B/Brisbane/60/2008 48.0
4.Primary Outcome
Title Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
Hide Description Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time Frame Day 0 (pre-vaccination) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description:
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Participants Analyzed 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers ratio
A/California/07/2009 (H1N1)
2.29
(1.93 to 2.71)
A/Texas/50/2012 (H3N2)
2.05
(1.76 to 2.39)
B/Massachusetts/2/2012
3.33
(2.57 to 4.31)
B/Brisbane/60/2008
4.59
(3.63 to 5.81)
5.Primary Outcome
Title Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Hide Description Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description:
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain 56.0
Grade 3 Injection-site Pain 0
Injection-site Erythema 6.0
Grade 3 Injection-site Erythema 0
Injection-site Swelling 4.0
Grade 3 Injection-site Swelling 0
Injection-site Induration 2.0
Grade 3 Injection-site Induration 0
Injection-site Ecchymosis 1.0
Grade 3 Injection-site Ecchymosis 0
Fever 0
Grade 3 Fever 0
Headache 8.0
Grade 3 Headache 0
Malaise 15.0
Grade 3 Malaise 1.0
Myalgia 45.0
Grade 3 Myalgia 1.0
Shivering 3.0
Grade 3 Shivering 0
Time Frame Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quadrivalent Influenza Vaccine
Hide Arm/Group Description Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
All-Cause Mortality
Quadrivalent Influenza Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quadrivalent Influenza Vaccine
Affected / at Risk (%) # Events
Total   0/100 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Quadrivalent Influenza Vaccine
Affected / at Risk (%) # Events
Total   56/100 (56.00%)    
General disorders   
Injection site Pain  1  56/100 (56.00%)  56
Injection site Erythema  1  6/100 (6.00%)  6
Malaise  1  15/100 (15.00%)  15
Infections and infestations   
Nasopharyngitis * 1  10/100 (10.00%)  10
Musculoskeletal and connective tissue disorders   
Myalgia  1  45/100 (45.00%)  45
Nervous system disorders   
Headache  1  8/100 (8.00%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01967784     History of Changes
Other Study ID Numbers: GQM09
U1111-1127-7693 ( Other Identifier: WHO )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: December 14, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016