Clinical Trial Results:
Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-Dose Primary and Booster Vaccination in Infants in Japan
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Summary
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EudraCT number |
2015-005187-42 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
08 Nov 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2016
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First version publication date |
16 Apr 2016
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Other versions |
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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 |
IPV35_EFC12403
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01389687 | ||
WHO universal trial number (UTN) |
U1111-1120-1735 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur 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 |
Head of Local Medical Operation, Sanofi Aventis K.K., Toshiaki.Sato@sanofi.com
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Scientific contact |
Head of Local Medical Operation, Sanofi Aventis K.K., Toshiaki.Sato@sanofi.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 |
08 Nov 2011
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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 |
08 Nov 2011
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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 |
1) To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV).
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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 |
01 Jul 2011
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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: 74
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Worldwide total number of subjects |
74
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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) |
74
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Children (2-11 years) |
0
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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 |
Study subjects were enrolled from 01 July 2011 to 08 November 2011 (primary series) and to 30 June 2012 (booster series) at 2 clinic centers in Japan. | ||||||
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Pre-assignment
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Screening details |
A total of 74 subjects who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated in the primary series study; 73 subjects in the booster series. | ||||||
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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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SP059 (Inactivated Poliovirus Vaccine; IPV) | ||||||
Arm description |
Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
SP059 (Inactivated Poliovirus vaccine types 1, 2, and 3)
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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 into the internal area of upper arm, 1 injection each at Day 0, 56, and 112 as primary vaccination series and a single booster dose 6-18 months post-dose 3.
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Baseline characteristics reporting groups
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Reporting group title |
SP059 (Inactivated Poliovirus Vaccine; IPV)
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Reporting group description |
Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.
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End points reporting groups
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Reporting group title |
SP059 (Inactivated Poliovirus Vaccine; IPV)
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Reporting group description |
Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. | ||
Subject analysis set title |
SP059 (Inactivated Poliovirus vaccine; IPV; Booster dose)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.
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End point title |
Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1] | ||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection was defined as Anti-Poliovirus 1, 2, and 3 antibody titers ≥ 8 (1/dil).
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End point type |
Primary
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End point timeframe |
Pre-Primary and Post-Primary 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 groups 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 Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [2] | ||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Pre-Primary and Post-Primary Vaccination
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| Notes [2] - 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 groups 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 Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Before and Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [3] | ||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Post-Primary/Pre-Primary Vaccination
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| Notes [3] - 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 groups 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 |
Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Three-Dose Primary Series Vaccination of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions (3 to 23 months): Tenderness, Erythema, and Swelling; (2 to 11 years): Pain, Erythema, and Swelling. Solicited systemic reactions (3 to 23 months): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability and (2 to 11 years): Fever, Headache, Malaise, and Myalgia.
Grade 3 injection site reactions: Tenderness (3 to 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm. Grade 3 systemic reactions (3 to 23 months): Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable and (2 to 11 years): Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 7 post-any dose primary series
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| Notes [4] - 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 groups 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 |
Percentage of Subjects with Seroprotection Against Poliovirus 1, 2 and 3 Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [5] | ||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Seroprotection was defined as Anti-Poliovirus 1, 2, and 3 antibody titers ≥ 8 (1/dil).
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End point type |
Primary
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End point timeframe |
Pre-Booster and Post-Booster Vaccination
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| Notes [5] - 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 groups 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 Anti-polio 1, 2, and 3 Antibodies Before and Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [6] | ||||||||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Pre-Booster and Post-Booster Vaccination
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| Notes [6] - 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 groups 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 Titer Ratios of Anti-polio 1, 2, and 3 Antibodies Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [7] | ||||||||||||||
End point description |
Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
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End point type |
Primary
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End point timeframe |
Post-Booster/Pre-Booster Vaccination
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| Notes [7] - 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 groups 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 |
Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following A Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [8] | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions (3 to 23 months): Tenderness, Erythema, and Swelling; (2 to 11 years): Pain, Erythema, and Swelling. Solicited systemic reactions (3 to 23 months): Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability and (2 to 11 years): Fever, Headache, Malaise, and Myalgia.
Grade 3 injection site reactions: Tenderness (3 to 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 50 mm. Grade 3 systemic reactions (3 to 23 months): Fever, ≥ 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable and (2 to 11 years): Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 7 post-booster vaccination
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| Notes [8] - 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 groups and the study vaccine administered for this outcome. |
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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 of primary series up to Day 7 post-booster vaccination.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
SP059 (Inactivated Poliovirus Vaccine; IPV)
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Reporting group description |
Subjects received three doses of Inactivated poliovirus vaccine (IPV) administered 3-8 weeks (21-56 days) apart as a three-dose primary vaccination starting at 3-68 (recommended 3-8 months) of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SP059 (Inactivated Poliovirus Vaccine; IPV; Booster dose)
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Reporting group description |
All subjects received a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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20 Jun 2011 |
Added the secondary endpoint for the evaluation of immunogenicity. |
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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 | |||
