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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00835237

First received: February 2, 2009

Last updated: January 5, 2012

Last verified: February 2011

History of Changes

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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

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

Hide Baseline Characteristics

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
Number of Participants [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

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. ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value
Measure Description	Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
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.
Analysis was performed on the According-To-Protocol (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
Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value [units: subjects]
Anti-D (≥ 0.1 IU/mL) (N= 859;432)	729	374
Anti-T (≥ 0.1 IU/mL) (N= 864;439)	836	428
Anti-T (≥ 1.0 IU/mL) (N= 864;439)	767	395

No statistical analysis provided for Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value

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) ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

7. Secondary:

Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

Show Outcome Measure 7

8. Secondary:

Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Hide Outcome Measure 10

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Serious Adverse Events (SAE)
Measure Description	An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame	From the vaccintation up to Day 182
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.
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)

Measured Values

	Boostrix Group	Decavac Group
Number of Participants Analyzed [units: participants]	887	445
Number of Subjects Reporting Serious Adverse Events (SAE) [units: subjects]	37	10

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events (SAE)

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.

Publications automatically indexed to this study:

Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. Epub 2011 Dec 31.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00835237 History of Changes
Other Study ID Numbers:	111413
Study First Received:	February 2, 2009
Results First Received:	July 8, 2010
Last Updated:	January 5, 2012
Health Authority:	United States: Food and Drug Administration

To Top