Clinical Trial Results:
Immunogenicity and Safety of the sanofi pasteur’s DTacP-IPV Combined Vaccine (TETRAXIM™) given as a booster dose at 4 to 6 years of life in children previously vaccinated with PENTAXIM™ in the study E2I34
Summary
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EudraCT number |
2015-005403-87 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
31 May 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Jun 2016
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First version publication date |
09 Jun 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 |
E2I57
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01031303 | ||
WHO universal trial number (UTN) |
U1111-1112-2680 | ||
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 Team Leader, Sanofi Pasteur, SA, 33 4 37 65 67 99, Emmanuel.vidor@sanofipasteur.com
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Scientific contact |
Medical Team Leader, Sanofi Pasteur, SA, 33 4 37 65 67 99, 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 |
16 Sep 2010
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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 |
31 May 2010
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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 assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur’s DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.
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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 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.
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Background therapy |
Subjects were vaccinated with PENTAXIM™ in a previous Study, 2015-005352-10 . | ||
Evidence for comparator |
Not applicable. | ||
Actual start date of recruitment |
19 Dec 2009
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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 |
Thailand: 123
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Worldwide total number of subjects |
123
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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) |
123
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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 19 December 2009 to 31 March 2010 at 2 clinical centers in Thailand. | ||||||
Pre-assignment
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Screening details |
Subjects who received Sanofi Pasteur's DTacP-IPV//PRP~T vaccine (Pentaxim™) as a 3-dose primary vaccination (at 2, 4, and 6 months of age) in parallel with a recombinant hepatitis B vaccination received at birth, 2 and 6 months of age in the study E2I34 are eligible for the booster dose study. | ||||||
Period 1
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Period 1 title |
Overall Study (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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Study Group | ||||||
Arm description |
Subjects received a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1). | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
DTacP-IPV combined vaccine
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Investigational medicinal product code |
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Other name |
TETRAXIM™
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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 into the right deltoid region
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Study Group
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Reporting group description |
Subjects received a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1). |
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End point title |
Percentage of Subjects with Seroprotection, Seroconversion/Vaccine Response After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10). [1] | ||||||||||||||||||||||||||||||||||
End point description |
Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
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End point type |
Primary
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End point timeframe |
Day 30 post-booster 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 booster vaccine administered in the study. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titers of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10). | ||||||||||||||||||||||||||||||||||||
End point description |
Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
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End point type |
Secondary
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End point timeframe |
Day 0 Pre-vaccination and Day 30 Post-vaccination
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10). | ||||||||||||||||||||||
End point description |
Anti-diphtheria (D) and Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test. Anti-Tetanus (T), anti-Pertussis toxoid (PT) and anti-Filamentous Haemagglutinin (FHA) antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination) and Day 30 Post-vaccination
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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 After A Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in a Previous Study (2015-005352-10) | ||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
Grade 3 injection-site Pain, Incapacitating, preventing the performance of usual activities; Erythema and Swelling, ≥5 cm; Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
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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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End point title |
Geometric Mean Titers of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study. | ||||||||||||||||||||||||||||||||
End point description |
Geometric Mean Titers were determined in subjects who received Oral Polio Vaccine (OPV), and those who did not received Oral Polio Vaccine (N/A)
Anti-poliovirus (IPV) types 1, 2, and 3 antibodies was measured by a toxin neutralization test.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and Day 30 Post-vaccination.
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Notes [2] - N = 11 for subject who received OPV (+ OPV) N = 112 for subject who did not receive OPV (N/A) |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titer Ratios of Antibodies Against Poliovirus Antigens Before and After Booster Vaccination with DTacP-IPV Combined Vaccine (TETRAXIM™) Following Primary PENTAXIM™ Vaccination in OPV and non-OPV Recipients in a Previous Study. | ||||||||||||||||||||
End point description |
Geometric Mean Titers were determined in subjects who received Oral Polio Vaccine (OPV), and those who did not received Oral Polio Vaccine (N/A)
Anti-poliovirus (IPV) types 1, 2, and 3 antibodies were measured by a toxin neutralization test.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and Day 30 post-vaccination.
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Notes [3] - N = 11 for subject who received OPV (+ OPV) N = 112 for subject who did not receive OPV (N/A) |
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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 events were reported from Day 0 up to Day 30 post-vaccination
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Study Group
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Reporting group description |
Subjects received a booster dose of study vaccine DTacP-IPV vaccine (TETRAXIM™) at 4 to 6 years of age (at visit 1). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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29 Oct 2009 |
This amendment was issued before the commencement of the trial to change the site of the intramuscular injection of the vaccine from anterolateral aspect of the right thigh to the right deltoid region. |
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13 Jan 2010 |
Protocol updated to allow inclusion of subjects that received or were to receive Oral Polio Vaccine (OPV) as part of the National Immunization Days (that occurred at the same time as study period in Thailand)
In the section on "Population used in the Analyses" the following text was added "In addition, anti polio 1, 2, and 3 antibody titers will be analyzed on the subset of subjects who did not receive OPV as part of the National Immunization Days campaign, as well as on the subset of subjects who received OPV as part of the National Immunization Days campaign."
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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 |