Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00465816

First received: April 24, 2007

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Results First Received: April 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Meningococcal Serogroup A, C, W-135, Y Diseases
Interventions:	Biological: Nimenrix (Meningococcal vaccine 134612) Biological: Twinrix

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
Nimenrix + Twinrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group	Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Participant Flow: Overall Study

	Nimenrix + Twinrix Group	Nimenrix Group	Twinrix Group
STARTED	367	122	122
COMPLETED	367	122	120
NOT COMPLETED	0	0	2
Lost to Follow-up	0	0	2

Baseline Characteristics

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Reporting Groups

	Description
Nimenrix + Twinrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group	Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Total	Total of all reporting groups

Baseline Measures

	Nimenrix + Twinrix Group	Nimenrix Group	Twinrix Group	Total
Number of Participants [units: participants]	367	122	122	611
Age [units: Years] Mean ± Standard Deviation	14.3 ± 1.89	14.3 ± 1.84	14.3 ± 1.94	14.3 ± 1.89
Gender [units: Subjects]
Female	195	61	68	324
Male	172	61	54	287

Outcome Measures

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1. Primary:

Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers [ Time Frame: At 1 month after vaccination with Nimenrix vaccine (Month 1) ]

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2. Primary:

Number of Subjects Seroconverted for Hepatitis A [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]

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3. Primary:

Number of Subjects Seroprotected for Hepatitis B [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]

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4. Secondary:

Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 [ Time Frame: At 1 month after vaccination with Nimenrix vaccine (Month 1) ]

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5. Secondary:

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]

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6. Secondary:

Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]

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Measure Type	Secondary
Measure Title	Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Measure Description	Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time Frame	Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
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.
The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.

Reporting Groups

	Description
Nimenrix + Twinrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group	Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group	Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Measured Values

	Nimenrix + Twinrix Group	Nimenrix Group	Twinrix Group
Number of Participants Analyzed [units: participants]	180	58	0
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations [units: micrograms per milliliter (µg/mL)] Geometric Mean ( 95% Confidence Interval )
Anti-PSA [Month 0] (N= 176; 55; 0)	0.25 ( 0.21 to 0.30 )	0.24 ( 0.19 to 0.31 )
Anti-PSA [Month 1] (N= 179; 56; 0)	27.23 ( 22.91 to 32.38 )	18.47 ( 12.02 to 28.38 )
Anti-PSC [Month 0] (N= 176; 55; 0)	0.22 ( 0.19 to 0.26 )	0.26 ( 0.19 to 0.35 )
Anti-PSC [Month 1] (N= 180; 55; 0)	18.58 ( 15.44 to 22.37 )	21.15 ( 14.87 to 30.09 )
Anti-PSW-135 [Month 0] (N= 167; 58; 0)	0.19 ( 0.17 to 0.21 )	0.16 ( 0.15 to 0.17 )
Anti-PSW-135 [Month 1] (N= 178; 58; 0)	6.78 ( 5.52 to 8.32 )	6.72 ( 4.62 to 9.76 )
Anti-PSY [Month 0] (N= 175; 58; 0)	0.22 ( 0.18 to 0.25 )	0.17 ( 0.14 to 0.21 )
Anti-PSY [Month 1] (N= 180; 55; 0)	14.04 ( 11.52 to 17.10 )	12.50 ( 8.49 to 18.41 )

No statistical analysis provided for Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations

7. Secondary:

Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]

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8. Secondary:

Anti-Tetanus Toxoid (TT) Antibody Concentrations [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]

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9. Secondary:

Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]

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10. Secondary:

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 [ Time Frame: At Month 7 ]

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11. Secondary:

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 [ Time Frame: At Month 7 ]

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12. Secondary:

Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 [ Time Frame: At Month 7 ]

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13. Secondary:

Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 [ Time Frame: At Month 7 ]

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14. Secondary:

Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]

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15. Secondary:

Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]

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16. Secondary:

IgG Anti-HBs Antibody Concentrations [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]

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17. Secondary:

Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]

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18. Secondary:

Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination [ Time Frame: During a 4-day period after Nimenrix vaccination ]

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19. Secondary:

Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination [ Time Frame: During a 4-day period after each Twinrix vaccination ]

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20. Secondary:

Number of Subjects Reporting Any Solicited General Symptoms [ Time Frame: During a 4-day period after any vaccination ]

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21. Secondary:

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: Up to 1 month after each vaccine dose ]

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22. Secondary:

Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses [ Time Frame: During the entire study (up to Month 7) ]

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23. Secondary:

Number of Subjects Reporting Any Rash [ Time Frame: During the entire study (up to Month 7) ]

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24. Secondary:

Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits [ Time Frame: During the entire study (up to Month 7) ]

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25. Secondary:

Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: During the entire study (up to Month 7) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

Ostergaard L et al. (2012) A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 30(4):774-83.

Publications automatically indexed to this study:

Østergaard L, Silfverdal SA, Berglund J, Flodmark CE, West C, Bianco V, Baine Y, Miller JM. A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 2012 Jan 17;30(4):774-83. Epub 2011 Nov 19.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00465816 History of Changes
Other Study ID Numbers:	109063
Study First Received:	April 24, 2007
Results First Received:	April 23, 2012
Last Updated:	November 21, 2012
Health Authority:	Sweden: Medical Products Agency

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