Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00835237

First received: February 2, 2009

Last updated: October 6, 2016

Last verified: October 2016

History of Changes

Results First Received: July 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Tetanus Acellular Pertussis Diphtheria
Interventions:	Biological: Boostrix® Biological: Decavac™

Participant Flow

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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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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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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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
Overall Participants Analyzed [Units: Participants]	887	445	1332

Age [Units: Years] Mean (Standard Deviation)	71.6 (5.35)	71.9 (5.62)	71.7 (5.44)

Gender [Units: Participants]
Female	478	237	715
Male	409	208	617

Outcome Measures

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1. Primary:

Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value [ Time Frame: One month after vaccination. ]

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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) ]

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3. Secondary:

Anti-T and Anti-D Antibody Concentrations [ Time Frame: Before (PRE) and one month after vaccination (POST) ]

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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 ]

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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 ]

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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 ]

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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

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 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
Participants Analyzed [Units: Participants]	864	439
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]
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 ]

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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

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
Participants Analyzed [Units: Participants]	882	445
Number of Subjects Reporting Solicited Local Symptoms [Units: Subjects]
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 ]

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9. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]

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10. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: From the vaccintation up to Day 182 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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