Clinical Trial Results:
Immunogenicity and Safety of ADACEL Polio (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose (Pre-School Booster) in Healthy Children in Taiwan
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Summary
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EudraCT number |
2015-005190-21 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
09 Apr 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Feb 2016
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First version publication date |
18 Feb 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 |
TD525
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00797511 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
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Public contact |
Medical Director Franchise, Sanofi Pasteur SA, 33 4 37 37 70 82, RegistryContactUS@sanofipasteur.com
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Scientific contact |
Medical Director Franchise, Sanofi Pasteur SA, 33 4 37 37 70 82, RegistryContactUS@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 Aug 2009
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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 |
09 Apr 2009
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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 describe the immunogenicity profile of ADACEL Polio (TdcP-IPV vaccine) one month after administration.
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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 |
ADACEL Polio was administered as a fifth dose following complete primary series and fourth dose of diphtheria, tetanus, pertussis vaccine and polio vaccines. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
24 Nov 2008
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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 |
Taiwan: 132
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Worldwide total number of subjects |
132
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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) |
132
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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 24 November 2008 to 11 March 2009 at 1 medical center in Taiwan. | ||||||||||
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Pre-assignment
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Screening details |
A total of 132 subjects who met the inclusion and none of the exclusion criteria were enrolled, vaccinated, and evaluated. | ||||||||||
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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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Adacel Polio Vaccine Study Group | ||||||||||
Arm description |
Subjects received one dose of TdcP-IPV vaccine (ADACEL Polio). | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine
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Investigational medicinal product code |
TdcP-IPV
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular in the left deltoid, 1 injection on Day 0.
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Baseline characteristics reporting groups
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Reporting group title |
Adacel Polio Vaccine Study Group
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Reporting group description |
Subjects received one dose of TdcP-IPV vaccine (ADACEL Polio). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Adacel Polio Vaccine Study Group
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Reporting group description |
Subjects received one dose of TdcP-IPV vaccine (ADACEL Polio). | ||
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End point title |
Number of Subjects With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine [1] | ||||||||||||||||||
End point description |
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL), anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL, and anti-polio (≥8 1/dilution).
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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 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 |
Number of Subjects With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine [2] | ||||||||||||||||
End point description |
The anti-Pertussis concentration was determined by ELISA. The criteria for demonstrating booster response were: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (pertussis toxoid [PT], filamentous hemagglutinin [FHA], fimbriae [FIM] types 2 and 3, and pertactin [PRN]) but post-vaccination levels ≥4X LLOQ, or (ii) Pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ with a 4-fold rise rate, or (iii) Pre-vaccination antibody concentrations ≥4X LLOQ but with a 2-fold rise rate.
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End point type |
Primary
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End point timeframe |
Day 28 post-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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End point title |
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination [3] | ||||||||||||||||||
End point description |
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
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End point type |
Primary
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End point timeframe |
Day 28 post-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 |
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio Vaccine [4] | ||||||||||||||||||||||||
End point description |
Pre- and post-vaccination GMTs for the pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis fimbriae types 2 and 3 (FIM) were all determined by enzyme-linked immunosorbent assay (ELISA).
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28 post-vaccination
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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 |
Number of Subjects Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With ADACEL Polio Vaccine | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited Injection site reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. By convention, extensive swelling of vaccinated limb is considered severe. Grade 3 Systemic reactions: Fever, >39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.
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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-vaccination) up to 1 month post-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 |
10.1
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Reporting groups
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Reporting group title |
Adacel Polio Vaccine Study Group
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Reporting group description |
Subjects received one dose of TdcP-IPV vaccine (ADACEL Polio). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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31 Dec 2008 |
Allowed Investigator the possibility to include potential subjects directly at the Hospital and not only through the schools in order to increase recruitment rate. |
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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 | |||
