Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00758264
• Date of registration: 23/09/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
• Scientific title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A
• Date of first enrolment: October 30, 2008
• Target sample size: 363
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00758264
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Mexico, Taiwan

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who the investigator believes that their parents/guardians can and will
comply with the requirements of the protocol.

- A male or female between, and including, 12 and 23 months of age at the time of the
first booster vaccination, who previously participated in study 109661 conducted in
Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the
GSK1024850A vaccine.

- Written informed consent obtained from the parent or guardian of the subject.

- 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) other than the
study vaccines within 30 days preceding the first dose of study vaccine(s), or planned
use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
within 30 days before the first dose of vaccine(s) and 30 days after the last dose of
vaccine(s).

- Concurrently participating 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 a
non-investigational product (pharmaceutical product or device).

- Previous vaccination with a meningococcal vaccine.

- Previous administration of a fourth dose of a pneumococcal vaccine

- Previous vaccination with tetanus toxoid within the last month (including also tetanus
toxoid given as part of Hib-TT conjugate vaccine).

- History of meningococcal or pneumococcal invasive disease.

- History of reactions or allergic disease likely to be exacerbated by any component of
the vaccines.

- Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.

- History of seizures (this criterion does not apply to subjects who have had a single,
uncomplicated febrile convulsion in the past) or progressive neurological disease.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection, based on medical history and physical
examination (no laboratory testing required).

- A family history of congenital or hereditary immunodeficiency, unless the child has
previously been documented, through laboratory testing, to have normal immune
function.

- Major congenital defects or serious chronic illness.

- Acute disease at the time of enrolment.

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



Age minimum: 12 Months
Age maximum: 23 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Meningococcal

Intervention(s)

Biological: Meningococcal vaccine GSK134612

Biological: Pneumococcal vaccine GSK1024850A

Primary Outcome(s)

Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (=) the Cut-off Value [Time Frame: At Month 1]

Anti-pneumococcal Antibody Concentrations [Time Frame: At Month 1]

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers [Time Frame: At Month 1]

Secondary Outcome(s)

Number of Subjects With Any Unsolicited Adverse Events (AEs) [Time Frame: Within the 31-day (Day 0-30) post-vaccination period after each dose]

Number of Subjects With Serious Adverse Events (SAEs) [Time Frame: Throughout the entire study duration (Day 0-Month 7)]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Time Frame: Within the 4-day (Days 0-3) post-vaccination period after each dose]

Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations [Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)]

Cross-reactive Anti-pneumococcal Antibody Concentrations [Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)]

Anti-protein D (Anti-PD) Antibody Concentrations [Time Frame: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)]

Number of Subjects Reporting Rash [Time Frame: Throughout the entire study duration (Day 0-Month 7)]

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes [Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)]

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Time Frame: Within the 4-day (Days 0-3) post-vaccination period after each dose]

Number of Subjects With New Onset Chronic Illnesses (NOCIs) [Time Frame: Throughout the entire study duration (Day 0-Month 7)]

Opsonophagocytic Titers Against Pneumococcal Serotypes [Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)]

rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers [Time Frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)]

Anti-pneumococcal Antibody Concentrations [Time Frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)]

Anti-tetanus (Anti-T) Antibody Concentrations [Time Frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)]

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [Time Frame: Throughout the entire study duration (Day 0-Month 7)]

Secondary ID(s)

111393

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00758264