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Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

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ClinicalTrials.gov Identifier: NCT02005536
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
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
Conditions Poliomyelitis
Polio
Intervention Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine
Enrollment 60
Recruitment Details Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan.
Pre-assignment Details A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
60
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
4.0  (0.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
25
  41.7%
Male
35
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 60 participants
60
1.Primary Outcome
Title Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Hide Description A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-polio booster response was assessed in the per-protocol analysis set.
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description:
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-polio 1 78.0
Anti-polio 2 78.0
Anti-polio 3 79.7
2.Secondary Outcome
Title Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Hide Description Anti-polio virus antibodies were assessed by virus neutralization assay.
Time Frame Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers was assessed in the per-protocol analysis set.
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description:
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Participants Analyzed 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-polio 1 (pre-vaccination)
312.6
(241.8 to 404.1)
Anti-polio 1 (post-vaccination)
3794.9
(3011.5 to 4782.1)
Anti-polio 2 (pre-vaccination)
795.4
(591.8 to 1069.1)
Ant-polio 2 (post-vaccination)
9213.2
(6754.5 to 12567.0)
Anti-polio 3 (pre-vaccination)
314.5
(219.5 to 450.4)
Anti-polio 3 (post-vaccination)
5242.1
(3912.9 to 7022.9)
3.Secondary Outcome
Title Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Hide Description Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay
Time Frame Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-polio booster response was assessed in the per-protocol analysis set.
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description:
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-polio 1 (pre-vaccination) 100
Anti-polio 1 (post-vaccination) 100
Anti -polio 2 (pre-vaccination) 100
Anti-polio 2 (post-vaccination) 100
Anti-polio 3 (pre-vaccination) 98.3
Anti-polio 3 (post-vaccination) 100
4.Secondary Outcome
Title Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Hide Description Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.
Time Frame Day 28 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description:
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Participants Analyzed 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer Ratio
Anti-polio 1
12.1
(8.5 to 17.4)
Anti-polio 2
11.6
(7.7 to 17.5)
Anti-polio 3
16.7
(9.8 to 28.4)
5.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Hide Description Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.
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 assessed in all participants who received study vaccine (Safety Analysis Set).
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description:
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: Number of participants
Any Injection-site Pain 13
Grade 3 Injection-site Pain 0
Any Injection-site Erythema 41
Grade 3 Injection-site Erythema 1
Any Injection-site Swelling 21
Grade 3 Injection-site Swelling 0
Any Fever 8
Grade 3 Fever 2
Any Headache 4
Grade 3 Headache 0
Any Malaise 18
Grade 3 Malaise 0
Any Myalgia 1
Grade 3 Myalgia 0
Time Frame Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
Adverse Event Reporting Description The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
 
Arm/Group Title IMOVAX POLIO® Vaccine Group
Hide Arm/Group Description Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
All-Cause Mortality
IMOVAX POLIO® Vaccine Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IMOVAX POLIO® Vaccine Group
Affected / at Risk (%)
Total   0/60 (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%
IMOVAX POLIO® Vaccine Group
Affected / at Risk (%)
Total   47/60 (78.33%) 
Gastrointestinal disorders   
Diarrhoea * 1  4/60 (6.67%) 
General disorders   
Injection Site Erythema  1  41/60 (68.33%) 
Injection Site Pain  1  13/60 (21.67%) 
Injection Site Swelling  1  21/60 (35.00%) 
Malaise  1  18/60 (30.00%) 
Fever  1  8/60 (13.33%) 
Pyrexia * 1  5/60 (8.33%) 
Infections and infestations   
Nasopharyngitis * 1  11/60 (18.33%) 
Upper respiratory tract infection * 1  4/60 (6.67%) 
Gastroenterities * 1  3/60 (5.00%) 
Varicella * 1  3/60 (5.00%) 
Nervous system disorders   
Headache  1  4/60 (6.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02005536     History of Changes
Other Study ID Numbers: IPV46 (EFC13614)
U1111-1143-8561 ( Other Identifier: WHO )
First Submitted: December 3, 2013
First Posted: December 9, 2013
Results First Submitted: March 17, 2015
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015