Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Condition or disease	Intervention/treatment	Phase
Infections, Meningococcal	Procedure: Blood Sampling	Phase 3

Detailed Description:

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	697 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Study Start Date :	September 2009
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group A; Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.	Procedure: Blood Sampling; A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
Active Comparator: Group B; Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.	Procedure: Blood Sampling; A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Outcome Measures

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Primary Outcome Measures :

1. Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups [ Time Frame: At Month 24 post primary dose ]
   A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
2. Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups [ Time Frame: At Month 36 post primary dose ]
   A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.
3. Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups [ Time Frame: At Month 48 post primary dose ]
   A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.
4. Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups [ Time Frame: At Month 60 post primary dose ]
   A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.

Secondary Outcome Measures :

1. Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups [ Time Frame: At Months 24, 36, 48 and 60 post primary dose ]
   A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals' laboratory.
2. Antibody Titers Against the Vaccine Meningococcal Serogroups [ Time Frame: At Months 24, 36, 48 and 60 post primary dose ]
   Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals' laboratory.
3. Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides [ Time Frame: At Month 24 post primary dose ]
   Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
4. Antibody Concentrations Against the Vaccine Polysaccharides [ Time Frame: At Month 24 post primary dose ]
   Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria

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Ages Eligible for Study:	11 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
• Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
• History of meningococcal disease; such cases will be documented.
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
• Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
• Subjects who withdrew consent to be contacted for follow-up studies.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

India
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
Indore, India, 452001
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Pune, India, 411 011
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00974363 History of Changes
Other Study ID Numbers:	112148
First Posted:	September 10, 2009
Results First Posted:	April 12, 2017
Last Update Posted:	April 12, 2017
Last Verified:	December 2016

Keywords provided by GlaxoSmithKline:

meningococcal vaccine GSK 134612

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections	Vaccines; Antibodies; Immunologic Factors; Physiological Effects of Drugs