Clinical Trial Results:
Large scale safety study of IMOVAX Polio in selected cities in China, an observational post marketing study
|
Summary
|
|
EudraCT number |
2015-005186-23 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
12 May 2011
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
16 Apr 2016
|
First version publication date |
16 Apr 2016
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
IPV34
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01278433 | ||
WHO universal trial number (UTN) |
U1111-1115-6566 | ||
|
Sponsors
|
|||
Sponsor organisation name |
Sanofi Pasteur China
|
||
Sponsor organisation address |
6th floor, No. 112 Jianguo Road, Chaoyang District, Beijing, China, 100022
|
||
Public contact |
Medical Director, Medical Affairs Department, Sanofi Pasteur China, 86 10-6568 5588, RegistryContactUS@sanofipasteur.com
|
||
Scientific contact |
Medical Director, Medical Affairs Department, Sanofi Pasteur China, 86 10-6568 5588, RegistryContactUS@sanofipasteur.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
30 Oct 2011
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
12 May 2011
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
- To describe serious adverse events (SAEs) within 30 days after each dose of IMOVAX Polio administered to infants at 2, 3 and 4 months of age and lived in the study cities of China.
|
||
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 kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were available on site in case of any immediate allergic reactions.
|
||
Background therapy |
Not applicable. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
10 Dec 2010
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
China: 5007
|
||
Worldwide total number of subjects |
5007
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
5007
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||||||||
|
Recruitment
|
|||||||||||||||||
Recruitment details |
Study subjects were enrolled from 10 December 2010 to 31 July 2011 in clinical centers in China. | ||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||
Screening details |
A total of 5007 subjects who met the inclusion, but none of the exclusion criteria were enrolled and vaccinated. | ||||||||||||||||
|
Period 1
|
|||||||||||||||||
Period 1 title |
Overall (overall period)
|
||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
Not applicable.
|
||||||||||||||||
|
Arms
|
|||||||||||||||||
|
Arm title
|
Study Group | ||||||||||||||||
Arm description |
Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Inactivated Poliomyelitis Vaccine (IMOVAX Polio)
|
||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||
Other name |
|||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||
Dosage and administration details |
0.5 mL, Intramuscular (IM) injection to the local sites of the anterolateral thigh or upper arm deltoid.
|
||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Infants subjects receiving IMOVAX Polio vaccine at 2, 3 and 4 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Study Group
|
||
Reporting group description |
Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age. | ||
|
|||||||||||||||||
End point title |
Number of Subjects With All and Related Serious Adverse Events within 30 Days After Any of A Three-Dose Primary Vaccination Series with Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1] | ||||||||||||||||
End point description |
Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), time to onset, duration, outcome, seriousness and relationship to vaccination of any SAEs reported up to 30 days after vaccination and whether the SAE led to early termination from the study.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
30 Days post-any injection
|
||||||||||||||||
| 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. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events data were collected from Day 0 (post-vaccination) up to 30 Days post-vaccination.
|
||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
|
||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||
Reporting group title |
Study Group
|
||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects vaccinated with a primary dose series of IMOVAX Polio at 2, 3 and 4 months of age. | ||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The primary objective of the study is to solicit and record serious adverse events. Non-serious adverse events were not solicited. |
|||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
