Clinical Trial Results:
Safety Among Adolescents and Adults of Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 4 to 5 Years After a Previous Dose
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Summary
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EudraCT number |
2015-005590-20 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
12 Oct 2007
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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 |
Td518
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00347958 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur Inc.
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Sponsor organisation address |
1 Discovery Drive, Swiftwater, United States, 18370
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Public contact |
Director, Clinical Development, Sanofi Pasteur Inc., 1 570-957-5647, oladayo.oyelola@sanofipasteur.com
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Scientific contact |
Director, Clinical Development, Sanofi Pasteur Inc., 1 570-957-5647, oladayo.oyelola@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? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Nov 2008
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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 |
12 Oct 2007
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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 provide safety data on revaccination with ADACEL vaccine
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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 |
Subjects in this study received a previous dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) vaccine as part of Sanofi Pasteur trial Td501, Td502, or Td505. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
21 Aug 2006
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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 |
United States: 194
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Country: Number of subjects enrolled |
Canada: 350
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Worldwide total number of subjects |
544
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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) |
0
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Adolescents (12-17 years) |
169
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Adults (18-64 years) |
368
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled from 21 August 2006 to 12 April 2007 in 6 clinical centers in the US and 6 clinical centers in Canada. | ||||||||||||||
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Pre-assignment
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Screening details |
A total of 545 subjects were enrolled and vaccinated in the study. Data on 544 subjects that met the inclusion and exclusion criteria were analyzed and reported. One subject who did not receive Adacel® vaccine in one of the previous studies was excluded from the Safety Analysis Set. | ||||||||||||||
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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® Vaccine Group | ||||||||||||||
Arm description |
Subjects 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, Td502, or Td505) and revaccinated in Study Td518. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular, 1 injection on Day 0.
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Baseline characteristics reporting groups
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Reporting group title |
Adacel® Vaccine Group
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Reporting group description |
Subjects 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, Td502, or Td505) and revaccinated in Study Td518. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Adacel® Vaccine Group
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Reporting group description |
Subjects 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, Td502, or Td505) and revaccinated in Study Td518. | ||
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End point title |
Percentage of Subjects With at Least 1 Solicited Injection Site and Systemic Reaction Post-Vaccination [1] | ||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions: Pain, Erythema, Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Myalgia, and Malaise. Grade 3 Injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever (Temperature), >39.0°C (>102.2°F), Headache, Myalgia, and Malaise, Prevents daily activities.
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End point type |
Primary
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End point timeframe |
Day 0 to Day 14 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 |
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination | ||||||||||||||||||||
End point description |
Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralizing testing. Tetanus antibody levels were determined by enzyme-linked immunosorbent assay testing.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and Day 28 post-vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination | ||||||||||||||||||||||||
End point description |
Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and Day 28 post-vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Tetanus and Diphtheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination with Adacel® | ||||||||||||||||||||
End point description |
Seroprotection was defined as tetanus or diphtheria titers ≥ 0.1 after Adacel® vaccination. Tetanus titers were determined by an enzyme-linked immunosorbent assay; diphtheria titers were determined by a toxin neutralization assay.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccinatino) and Day 28 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 the day of vaccination to 6 months 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 |
9.1
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Reporting groups
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Reporting group title |
Adacel® Vaccine Group
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Reporting group description |
Subjects 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, Td502, or Td505) and revaccinated in Study Td518. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. |
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Substantial protocol amendments (globally) |
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Date |
Amendment |
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07 Mar 2006 |
Changes were made to indicate the delay in the start of the trial, the increase in age limit for prospective subjects to 15 to ≤69 years of age, the planned locations, changes in personnel, and clarification regarding pregnancy test for all females prior to enrollment. |
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05 Jun 2006 |
Changes included an increase in planned sample size, inclusion of comparative analyses of demographics and safety outcomes from previous studies, collection of sera from all subjects, stratification of enrollment by pre-specified age groups, expanded monitoring time period and reporting procedures for solicited and unsolicited events, revised Informed Consent Form, updated thresholds and fold-rises for pertussis, and the revaccination approach was refined. |
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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 | |||
