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Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

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ClinicalTrials.gov Identifier: NCT01229397
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : May 20, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inflexal V
Enrollment 205
Recruitment Details Recruitment period: 05 October - 17 January 2011; Location: University of Milan
Pre-assignment Details  
Arm/Group Title Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
Hide Arm/Group Description

2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:

  • 7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus
  • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus

1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:

  • 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
  • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 15 μg HA antigen of B/Brisbane/60/2008-like virus
Period Title: Overall Study
Started 103 102
Completed 92 93
Not Completed 11 9
Reason Not Completed
Withdrawal by Subject             3             3
Lost to Follow-up             7             6
Migrated/moved from study area             1             0
Arm/Group Title Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1 Total
Hide Arm/Group Description Two 0.25 mL doses (on Day 1 and 29) One 0.5 mL dose (on Day 1) Total of all reporting groups
Overall Number of Baseline Participants 103 102 205
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 102 participants 205 participants
<=18 years
103
 100.0%
102
 100.0%
205
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 102 participants 205 participants
1.8  (0.52) 1.8  (0.61) 1.8  (0.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 102 participants 205 participants
Female
37
  35.9%
37
  36.3%
74
  36.1%
Male
66
  64.1%
65
  63.7%
131
  63.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 103 participants 102 participants 205 participants
103 102 205
1.Primary Outcome
Title Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Hide Description Seroprotection rate
Time Frame This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
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Hide Analysis Population Description
Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
Arm/Group Title Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
Hide Arm/Group Description:
Two 0.25 mL doses (on Day 1 and 29)
One 0.5 mL dose (on Day 1)
Overall Number of Participants Analyzed 98 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage subjects
Percentage of subjects seroprotected: A/H1N1
99.0
(94.4 to 100)
98.0
(92.9 to 99.8)
Percentage of subjects seroprotected: A/H3N2
99.0
(94.4 to 100)
97.0
(91.4 to 99.4)
Percentage of subjects seroprotected: B-strain
92.2
(85.8 to 97.1)
86.9
(78.6 to 92.8)
2.Primary Outcome
Title Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Hide Description Seroconversion rate
Time Frame This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
Arm/Group Title Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
Hide Arm/Group Description:
Two 0.25 mL doses (on Day 1 and 29)
One 0.5 mL dose (on Day 1)
Overall Number of Participants Analyzed 98 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage subjects
Percentage of subjects seroconverted: A/H1N1
92.9
(85.1 to 97.3)
95.5
(88.8 to 98.7)
Percentage of subjects seroconverted: A/H3N2
99.0
(94.4 to 100)
97.0
(91.4 to 99.4)
Percentage of subjects seroconverted: B-strain
92.9
(85.8 to 97.1)
86.9
(78.6 to 92.8)
3.Primary Outcome
Title Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Hide Description GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time Frame This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers
Arm/Group Title Inflexal V 0.25 mL x 2 Inflexal V 0.5 mL x 1
Hide Arm/Group Description:
Two 0.25 mL doses (on Day 1 and 29)
One 0.5 mL dose (on Day 1)
Overall Number of Participants Analyzed 98 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Fold (ratio)
GMT fold increase from baseline: A/H1N1
25.5
(21.3 to 30.5)
19.6
(16.9 to 22.7)
GMT fold increase from baseline: A/H3N2
31.6
(26.7 to 37.3)
24.6
(20.7 to 29.3)
GMT fold increase from baseline: B-strain
12.8
(11.2 to 14.6)
14.7
(12.3 to 17.4)
4.Secondary Outcome
Title Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Hide Description [Not Specified]
Time Frame Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all vaccinated subjects
Arm/Group Title Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination Inflexal V 0.5 mL x 1
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 102 101 100
Measure Type: Number
Unit of Measure: participants
AEs (unsolicited and solicited) 51 48 49
Unsolicited AEs 29 32 30
Solicited local AEs 22 16 17
Solicited systemic AEs 16 16 20
Time Frame Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination Inflexal V 0.5 mL x 1
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination Inflexal V 0.5 mL x 1
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination Inflexal V 0.5 mL x 1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/102 (0.98%)      0/101 (0.00%)      5/100 (5.00%)    
Infections and infestations       
Pneumonia * 1  0/102 (0.00%)  0 0/101 (0.00%)  0 1/100 (1.00%)  1
Bronchopneumonia * 1  0/102 (0.00%)  0 0/101 (0.00%)  0 1/100 (1.00%)  1
Gastroenterisits rotavirus * 1  0/102 (0.00%)  0 0/101 (0.00%)  0 1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/102 (0.98%)  1 0/101 (0.00%)  0 1/100 (1.00%)  1
Bronchopulmonary Disease * 1  0/102 (0.00%)  0 0/101 (0.00%)  0 1/100 (1.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Inflexal V 0.25 mL x 2 - After 1st Vaccination Inflexal V 0.25 mL x 2 - After 2nd Vaccination Inflexal V 0.5 mL x 1
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/102 (50.00%)      48/101 (47.52%)      49/100 (49.00%)    
General disorders       
Pyrexia  1  8/102 (7.84%)  8 11/101 (10.89%)  11 15/100 (15.00%)  15
Pyrexia * 1  11/102 (10.78%)  11 10/101 (9.90%)  13 9/100 (9.00%)  9
Erythema (at the injection site)  1  15/102 (14.71%)  15 7/101 (6.93%)  7 10/100 (10.00%)  10
Induration (at the injection site)  1  7/102 (6.86%)  7 2/101 (1.98%)  2 6/100 (6.00%)  6
Pain (at the injection site)  1  11/102 (10.78%)  11 10/101 (9.90%)  10 9/100 (9.00%)  9
Haemorrhage (at the injection site)  1  3/102 (2.94%)  3 4/101 (3.96%)  4 5/100 (5.00%)  5
Malaise  1  9/102 (8.82%)  9 8/101 (7.92%)  8 7/100 (7.00%)  7
Infections and infestations       
Otitis media acute * 1  4/102 (3.92%)  4 3/101 (2.97%)  3 5/100 (5.00%)  5
Rhinitis * 1  1/102 (0.98%)  1 9/101 (8.91%)  10 2/100 (2.00%)  2
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/102 (0.00%)  0 8/101 (7.92%)  8 3/100 (3.00%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 60 days from the time submitted to the sponsor for review. The sponsor reserves the right to remove any proprietary or confidential information and to require that publication be delayed for up to 60 additional days to enable the sponsor to prepare and file patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Affairs Director
Organization: Crucell Switzerland AG
Phone: +41(0)319806111
EMail: info@crucell.com
Layout table for additonal information
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01229397    
Other Study ID Numbers: INF-V-A005
First Submitted: October 22, 2010
First Posted: October 27, 2010
Results First Submitted: October 23, 2012
Results First Posted: May 20, 2013
Last Update Posted: February 6, 2014