Phase 3
Completed N=1,352
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00453986 ↗
Enrolled (actual)
1,352
Serious AEs
0.6%
Results posted
May 2012
Primary outcomePrimary: 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. — 3913.1; 3503.5; 3470.8; 9467.0 Titers
Summary
The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
3913.1; 3503.5; 3470.8; 9467.0; 8118.7; 9051.0 | — |
| PRIMARY 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. |
25; 107; 151; 488; 64; 198 | — |
| PRIMARY 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) |
2831.1; 3784.2; 6579.5; 10130.8; 4394.8; 6016.8 | — |
| PRIMARY Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. |
54.1; 537.2; 31.5; 177.8; 20.9; 192.7 | — |
| PRIMARY Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. |
75; 65; 78 | — |
| PRIMARY Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. |
9.9; 5.6; 9.1 | — |
| PRIMARY Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. |
68; 104; 57; 102; 44; 100 | — |
| SECONDARY 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. |
226; 207; 212; 292; 287; 289 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. |
215.1; 172.6; 157.5; 87.6; 83.2; 75.1 | — |
| SECONDARY 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 |
81; 219; 82; 102; 305; 104 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort |
200.5; 154.8; 250.8; 2831.1; 3784.2; 1826.9 | — |
| SECONDARY 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. |
645; 229; 868; 291; 650; 223 | — |
| SECONDARY 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. |
180.4; 216.3; 3624.7; 2127.2; 81.7; 91.2 | — |
| SECONDARY 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 |
5; 44; 6; 60; 168; 50 | — |
| SECONDARY 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. |
454; 153; 703; 156 | — |
| SECONDARY Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. |
0.245; 0.265; 3.488; 0.279 | — |
| SECONDARY 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 |
61; 193; 54; 84; 254; 53 | — |
| SECONDARY Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort |
0.295; 0.418; 0.287; 3.073; 4.655; 0.276 | — |
| SECONDARY 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. |
354; 125; 432; 144; 130; 61 | — |
| SECONDARY 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. |
2.14; 2.65; 101.79; 56.89; 0.33; 0.38 | — |
| SECONDARY 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 |
46; 136; 51; 49; 151; 52 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort |
2.40; 4.08; 3.83; 56.47; 142.33; 56.43 | — |
| SECONDARY 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. |
180; 42; 4; 1; 82; 14 | — |
| SECONDARY 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. |
23; 84; 16; 1; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine |
29; 1; 7; 0; 7; 1 | — |
| SECONDARY 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. |
114; 30; 8; 0; 37; 14 | — |
| SECONDARY Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort |
10; 33; 12; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. |
10; 3 | — |
| SECONDARY 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. |
0; 0 | — |
| SECONDARY 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. |
13; 1 | — |
| SECONDARY Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort |
0; 3; 0 | — |
| SECONDARY Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort |
0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort |
0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. |
135; 47 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. |
7; 1 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort |
13; 50; 20 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort |
0; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
For all subjects:
- 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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00453986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.