Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
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ClinicalTrials.gov Identifier: NCT00974363 |
Recruitment Status
:
Completed
First Posted
: September 10, 2009
Results First Posted
: April 12, 2017
Last Update Posted
: April 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infections, Meningococcal | Procedure: Blood Sampling | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
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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
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Active Comparator: Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
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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
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974363
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00974363 History of Changes |
Other Study ID Numbers: |
112148 |
First Posted: | September 10, 2009 Key Record Dates |
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 |