Clinical Trial Results:
Three-, Five-, and Ten-Year Data on the Long-Term Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) in Adolescents 11–14 Years of Age
Summary
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EudraCT number |
2015-005196-24 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
04 Jun 2009
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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 |
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 |
TD9809-LT
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02040636 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur Limited
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Sponsor organisation address |
1755 Steeles Ave. West, Toronto, Canada, M2R 3T4
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Public contact |
Clinical Team Leader, Sanofi Pasteur Limited, 1 416-667-2273, Miggi.Tomovici@sanofipasteur.com
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Scientific contact |
Clinical Team Leader, Sanofi Pasteur Limited, 1 416-667-2273, Miggi.Tomovici@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 |
04 Jun 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 |
04 Jun 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. The objective of this study was to describe the antibody levels for tetanus, diphtheria, pertussis and polio at 3 years, 5 years, and 10 years after vaccination with TdcP-IPV Vaccine.
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Protection of trial subjects |
Subjects were vaccinated in a previous study, Td9809. No vaccination was administered as part of this long-term immunogenicity follow-up study.
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Background therapy |
In Td9809, subjects were randomized to receive either Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine Combined with Inactivated Poliomyelitis Vaccine (TdcP-IPV) followed by Hepatitis B vaccine one month later or TdcP-IPV vaccine and Hepatitis B vaccine concomitantly. For the long-term follow-up study, subjects in both groups were recalled for serology at 3, 5, and 10 years. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jan 2002
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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 |
Canada: 277
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Worldwide total number of subjects |
277
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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) |
101
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Adolescents (12-17 years) |
176
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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 |
The study subjects were enrolled from 23 January 2002 to 04 June 2009 at 1 clinic center in Canada. | |||||||||||||||
Pre-assignment
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Screening details |
A total of 277 subjects who met all inclusion and none of the exclusion criteria were enrolled in the long-term immunogenicity study. | |||||||||||||||
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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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: Tdcp-IPV/Hepatitis B | |||||||||||||||
Arm description |
Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine with Inactivated Poliovirus (TdcP-IPV Vaccine)
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Investigational medicinal product code |
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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, 1 injection at Month 0.
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Investigational medicinal product name |
Hepatitis B Vaccine (Recombivax HB®)
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Investigational medicinal product code |
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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, 1 injection each at Months 1, 2, and 7.
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Arm title
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Group 2: Tdcp-IPV and Hepatitis B | |||||||||||||||
Arm description |
Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Tetanus and Diphtheria Toxoids Adsorbed and Component Pertussis Vaccine with Inactivated Poliovirus (TdcP-IPV Vaccine)
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Investigational medicinal product code |
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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, 1 injection at Month 0.
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Investigational medicinal product name |
Hepatitis B Vaccine (Recombivax HB®)
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Investigational medicinal product code |
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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, 1 injection at Month 0 concurrent with TdcP-IPV and 1 injection each at Months 1 and 6.
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: Tdcp-IPV/Hepatitis B
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Reporting group description |
Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: Tdcp-IPV and Hepatitis B
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Reporting group description |
Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: Tdcp-IPV/Hepatitis B
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Reporting group description |
Subjects received TdcP-IPV at month 0 and Hepatitis B at months 1, 2, and 7. | ||
Reporting group title |
Group 2: Tdcp-IPV and Hepatitis B
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Reporting group description |
Subjects received TdcP-IPV and Hepatitis B at Month 0, Hepatitis B at months 1 and 6. |
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End point title |
Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently [1] | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.01 IU/mL for Diphtheria and ≥ 0.01 EU/mL for Tetanus.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years 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 vaccine groups from the primary series for the long term follow-up period. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Seroprotection to Tetanus and Diphtheria Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as post-vaccination antibody titers ≥ 0.1 IU/mL for Diphtheria and ≥ 0.1 EU/mL for Tetanus.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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End point title |
Summary of Geometric Mean Titers of Antibodies for Diphtheria and Tetanus Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Diphtheria antibody responses were measured using a micrometabolic inhibition test. Anti-Tetanus antibody responses were measured using an enzyme-linked immunosorbent assay (ELISA).
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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End point title |
Summary of Geometric Mean Titers of Antibodies for Pertussis Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect enzyme-linked immunosorbent assay (ELISA).
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Seropositivity to Pertussis Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-Pertussis (Pertussis toxoid, Filamentous hemagglutinin, Fimbriae types 2 and 3, and Pertactin) antibody responses were measured using an indirect enzyme-linked immunosorbent assay (ELISA). Seropositivity rates, defined as the percentage of subjects with post-vaccination titers ≥ lower limit of quantitation.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Seroprotection to Poliovirus Antigens Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-poliovirus types 1, 2, and 3 titers were measured by a neutralization assay. Seroprotection was defined as antibody titers ≥ 1:8 dilution.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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End point title |
Summary of Geometric Mean Titers of Poliovirus Antibodies Following Vaccination with Either TdcP-IPV or TdcP-IPV and Hepatitis B Vaccine Given Concurrently | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-poliovirus types 1, 2, and 3 titers were measured by a neutralization assay.
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End point type |
Other pre-specified
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End point timeframe |
Day 0 (pre-vaccination) and 1 month and 3, 5, and 10 years post-vaccination
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
This was a long-term immunogenicity follow-up study of subjects who participated in a previous study, Td9809. No vaccines were administered in this study and adverse event data were also not collected.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
10
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: This was a long-term immunogenicity follow-up study of subjects who participated in a previous study, Td9809. No vaccines were administered in this study and adverse event data were also not collected |
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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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23 May 2001 |
Details regarding the planned long-term follow-up serology studies were included which also involved the collection of additional blood samples at 1, 3, 5, and 10 years post-vaccination. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/25540274 |