Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00835237
First received: February 2, 2009
Last updated: January 5, 2012
Last verified: February 2011
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Results First Received: July 8, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Conditions: |
Diphtheria Pertussis Diphtheria-Tetanus-acellular Pertussis Vaccines Tetanus |
| Interventions: |
Biological: Boostrix® Biological: Decavac™ |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Boostrix Group | Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) |
| Decavac Group | Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) |
Participant Flow: Overall Study
| Boostrix Group | Decavac Group | |
|---|---|---|
| STARTED | 887 | 445 |
| COMPLETED | 881 | 445 |
| NOT COMPLETED | 6 | 0 |
| Lost to Follow-up | 4 | 0 |
| Withdrawal by Subject | 2 | 0 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Boostrix Group | Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) |
| Decavac Group | Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) |
| Total | Total of all reporting groups |
Baseline Measures
| Boostrix Group | Decavac Group | Total | |
|---|---|---|---|
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Number of Participants
[units: participants] |
887 | 445 | 1332 |
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Age
[units: years] Mean (Standard Deviation) |
71.6 (5.35) | 71.9 (5.62) | 71.7 (5.44) |
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Gender
[units: participants] |
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| Female | 478 | 237 | 715 |
| Male | 409 | 208 | 617 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value [ Time Frame: One month after vaccination. ] |
| 2. Primary: | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration [ Time Frame: Before (PRE) and one month after vaccination (POST) ] |
| 3. Secondary: | Anti-T and Anti-D Antibody Concentrations [ Time Frame: Before (PRE) and one month after vaccination (POST) ] |
| 4. Secondary: | Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off [ Time Frame: One month after vaccination ] |
| 5. Secondary: | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off [ Time Frame: One month after vaccination ] |
| 6. Secondary: | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions. [ Time Frame: One month after vaccination ] |
Hide Outcome Measure 6
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions. |
| Measure Description |
Vaccine response defined as: For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination. For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration. |
| Time Frame | One month after vaccination |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results |
Reporting Groups
| Description | |
|---|---|
| Boostrix Group | Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) |
| Decavac Group | Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) |
Measured Values
| Boostrix Group | Decavac Group | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
864 | 439 |
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Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
[units: subjects] |
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| Anti-PT (N=846;430) | 699 | 9 |
| Anti-FHA (N=821;422) | 765 | 8 |
| Anti-PRN (N=864;439) | 714 | 11 |
No statistical analysis provided for Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.
| 7. Secondary: | Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ] |
Hide Outcome Measure 7
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Solicited Local Symptoms |
| Measure Description | Solicited local symptoms assessed include pain, redness and swelling. |
| Time Frame | Within the 4-day (Day 0-3) post-vaccination period |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the Total Vaccinated cohort on subjects with available results |
Reporting Groups
| Description | |
|---|---|
| Boostrix Group | Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine) |
| Decavac Group | Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine) |
Measured Values
| Boostrix Group | Decavac Group | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
882 | 445 |
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Number of Subjects Reporting Solicited Local Symptoms
[units: subjects] |
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| Pain | 190 | 123 |
| Redness | 95 | 56 |
| Swelling | 66 | 52 |
No statistical analysis provided for Number of Subjects Reporting Solicited Local Symptoms
| 8. Secondary: | Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ] |
| 9. Secondary: | Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ] |
| 10. Secondary: | Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: From the vaccintation up to Day 182 ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |