Clinical Trial Results:
Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan (IPV46)
Summary
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EudraCT number |
2015-003279-31 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
03 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
12 May 2016
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First version publication date |
12 May 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
IPV46/EFC13614
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02005536 | ||
WHO universal trial number (UTN) |
U1111-1143-8561 | ||
Sponsors
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Sponsor organisation name |
Sanofi K.K.
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Sponsor organisation address |
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1488
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Public contact |
PMS Management Supervisor, Sanofi K.K., 33 4376 56799, Emmanuel.vidor@sanofipasteur.com
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Scientific contact |
PMS Management Supervisor, Sanofi K.K., 33 4376 56799, Emmanuel.vidor@sanofipasteur.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Oct 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as a second booster.
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
02 Dec 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
60
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled from 02 December 2013 to 28 April 2014 at 4 clinic centers in Japan. | ||||||
Pre-assignment
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Screening details |
A total of 60 subjects who met all of the inclusion 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. | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not applicable
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Arms
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Arm title
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IMOVAX POLIO® Vaccine Group | ||||||
Arm description |
Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
SP059, IMOVAX POLIO® (Inactivated Poliovirus Vaccine; IPV)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
0.5 mL, subcutaneous, single dose.
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Baseline characteristics reporting groups
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Reporting group title |
IMOVAX POLIO® Vaccine Group
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Reporting group description |
Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IMOVAX POLIO® Vaccine Group
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Reporting group description |
Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0. |
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End point title |
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® [1] | ||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Day 28 post-vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study group and the study vaccine administered for this outcome. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titers of Vaccine Antigens Before and After Vacination With IMOVAX POLIO® | ||||||||||||||||||||
End point description |
Anti-polio virus antibodies were assessed by virus neutralization assay.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® | ||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vacination With IMOVAX POLIO® | ||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Day 28 post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® | ||||||||||||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-vaccination
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
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Adverse event reporting additional description |
The total number (47) reporting other adverse events at the 5% frequency are those subjects with solicited injection site and systemic reactions.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
IMOVAX POLIO® Vaccine Group
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Reporting group description |
Subjects received a single booster dose of IMOVAX POLIO® vaccine on Day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Sep 2013 |
Minor logistic modifications. |
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25 Sep 2013 |
Minor logistic modifications |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |