Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01235975
• Date of registration: 04/11/2010
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
• Scientific title: Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older
• Date of first enrolment: November 30, 2010
• Target sample size: 400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01235975
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Lebanon, Saudi Arabia

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol

- A male or female 56 years of age or older at the time of the vaccination.

- Written informed consent obtained from the subject.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Non-child-bearing potential is defined as current tubal ligation, hysterectomy,
ovariectomy or post-menopause.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccine(s)
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.

- Concurrent participation in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or
non-investigational product.

- Extended administration of immunosuppressants or other immune-modifying drugs within
six months prior to the vaccination. Inhaled and topical steroids are allowed.

- Any contra-indication to intramuscular and /or subcutaneous injection.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination
with inactivated influenza vaccines, including H1N1, is allowed at any time during the
study as per local recommendations).

- Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide
vaccine within 5 years prior to vaccination.

- Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y
polysaccharide conjugate vaccine.

- Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to
vaccination.

- History of meningococcal disease due to serogroups A, C, W-135 or Y.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Family history of congenital or hereditary immunodeficiency.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- History of neurological disorders and seizures

- History of Guillain-Barre syndrome.

- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or pre-existing
laboratory screening tests.

- Acute disease and/or fever at the time of enrolment.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine/product or planned administration during the
study period.

- Pregnant or lactating female.

- Current chronic alcohol consumption and/or drug abuse.



Age minimum: 56 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Meningococcal

Intervention(s)

Biological: Meningococcal vaccine GSK 134612

Biological: MencevaxACWY TM

Primary Outcome(s)

Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY) [Time Frame: One month after vaccination (Month 1)]

Secondary Outcome(s)

Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations = the Cut-off Value [Time Frame: At Day 0 and Month 1]

Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations [Time Frame: At Day 0 and Month 1]

Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations = the Cut-off Value [Time Frame: At Day 0 and Month 1]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Time Frame: Within 4 days (Day 0 to 3) post-vaccination]

Number of Subjects With Any Unsolicited Adverse Events (AEs) [Time Frame: Within 31 days (Day 0 to 30) after vaccination]

Number of Subjects With New Onset Chronic Illnesses (NOCI) [Time Frame: Within 31 days (Day 0 to 30) after vaccination]

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Time Frame: Within 4 days (Day 0 to 3) post-vaccination]

Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations = the Cut-off Value [Time Frame: At Day 0 and Month 1]

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers = the Cut-off Value [Time Frame: At Day 0 and Month 1]

Number of Subjects With Serious Adverse Events (SAEs) [Time Frame: Within 31 days (Day 0 to 30) after vaccination]

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers [Time Frame: At Day 0 and Month 1]

Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations [Time Frame: At Day 0 and Month 1]

Secondary ID(s)

113807

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01235975