Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Trial overview
Serum bactericidal assay (performed using baby rabbit complement) for Neisseria meningitidis serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibody titers, in each of the 3 lot groups.
Timeframe: One month after vaccination (at Month 1)
Number of subjects with a vaccine response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: One month after vaccination (at Month 1)
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers, in subjects receiving the Nimenrix Lot A + Fluarix vaccines or the Nimenrix vaccine (pooled lots in the Flu vaccine cohort)
Timeframe: One month after vaccination (at Month 1)
Serum haemagglutination inhibition (HI) antibody titers against each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of seroconverted subjects for HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.
Timeframe: One month after vaccination (at Month 1)
Seroconversion factor for HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.
Timeframe: One month after vaccination (at Month 1)
Number of seroprotected subjects HI antibody titers for each of the 3 influenza virus strains, in subjects receiving the Fluarix vaccine.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1)
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, in each of the 3 lot groups.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, in each of the 3 lot groups.
Timeframe: Prior to vaccination (at Month 0).
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers equal to or above the cut-off values, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with a vaccine response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody, for subjects in the Flu vaccine cohort
Timeframe: One month after vaccination (at Month 1)
Number of subjects with anti-tetanus antibody concentrations equal to or above the cut-off value of 0.1 International unit per milliliter (IU/mL), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-tetanus antibody concentrations, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with anti-tetanus antibody concentrations equal to or above the cut-off value of 0.1 International unit per milliliter (IU/mL), for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-tetanus antibody concentrations for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with anti-meningococcal polysaccharide serogroups, A, C, W-135 and Y antibody concentrations equal to or above the cut-off values, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations equal to or above the cut-off values, for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-PSA, anti-PSC, anti-PSW-135 & anti-PSY antibody concentrations, for subjects in the Flu vaccine cohort
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).
Number of subjects with any and severe solicited local symptoms, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination
Number of subjects with any and severe solicited local symptoms, for subjects in the Flu vaccine cohort receiving the Nimenrix or the Mencevax ACWY vaccines.
Timeframe: During the 4-day (Days 0-3) follow-up period after meningococcal vaccination
Number of subjects with any and severe solicited local symptoms, in subjects receiving the Fluarix vaccine
Timeframe: During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration
Number of subjects with any and severe solicited general symptoms, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination
Number of subjects with any and severe solicited general symptoms, for subjects in the Flu vaccine cohort
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination
Number of subjects reporting rash, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting new onset of chronic illness(es) (NOCIs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting adverse events (AEs) resulting in emergency room (ER) visits, in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting rash, for subjects in the Flu vaccine cohort
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting new onset of chronic illness(es) (NOCIs), for subjects in the Flu vaccine cohort
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting adverse events (AEs) resulting in emergency room (ER) visits, for subjects in the Flu vaccine cohort
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting unsolicited adverse events (AEs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)
Number of subjects reporting serious adverse events (SAEs), in subjects receiving the Nimenrix (from the 3 manufactured lots pooled) or the Mencevax ACWY vaccines.
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
Number of subjects reporting unsolicited adverse events (AEs), for subjects in the Flu vaccine cohort
Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)
Number of subjects reporting serious adverse events (SAEs), for subjects in the Flu vaccine cohort
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)
- For all subjects:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- For all subjects:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 55 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her knowledge.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test, and continue such precautions for 2 months after completion of the vaccination series.
For all subjects:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y within the last five previous years.
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- Previous vaccination with tetanus toxoid within the last month.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- 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.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions. Additional criteria for subjects receiving Fluarix™ co-administration:
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate.
- History of administration of an influenza vaccine outside of this study, during current flu season.
For all subjects:
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.