Infections, MeningococcalPhase 3NCT00453986
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
A Phase 3 study testing Meningococcal vaccine GSK134612, Mencevax™ACWY and Fluarix™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal vaccine GSK134612, Mencevax™ACWY and Fluarix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,352 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Apr 2007to 21 May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Philippines3 sites
GSK Investigational Site
Cavite, 4114
GSK Investigational Site
City of Muntinlupa
GSK Investigational Site
Manila
About this study
Official title: Lot-to-Lot Consistency, Non-Inferiority Versus Mencevax™ and Evaluation of the Co-Administration With Fluarix™ of GSK Biologicals' Meningococcal Vaccine GSK134612, in Healthy Subjects Aged 18 Through 55 Years of Age
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.
Read the detailed description
Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group.
Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal vaccine GSK134612, Mencevax™ACWY, Fluarix™
- Keywords
- immunogenicity, Meningococcal serogroups A, C, W-135 and/or Y disease, co-administration, meningococcal vaccine, lot-to-lot consistency, conjugate vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal vaccine GSK134612Biological
One intramuscular dose
Mencevax™ACWYBiological
One subcutaneous dose
Fluarix™Biological
One intramuscular dose
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix A Group | Experimental | subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Receives: Biological: Meningococcal vaccine GSK134612 |
| Nimenrix B Group | Experimental | subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Receives: Biological: Meningococcal vaccine GSK134612 |
| Nimenrix C Group | Experimental | subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Receives: Biological: Meningococcal vaccine GSK134612 |
| Mencevax ACWY Group | Active comparator | subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm. Receives: Biological: Mencevax™ACWY |
| Nimenrix+Fluarix Group | Experimental | subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Fluarix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Measured: 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.
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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)
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).
Measured: 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.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Measured: 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.
Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain.
Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Measured: 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.
Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Measured: 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.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Measured: Prior to and one month after vaccination (at Month 0 and Month 1)
Secondary outcomes (30)
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.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Measured: 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.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Measured: 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
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 \& PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.
Measured: 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.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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.
AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.
Measured: 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.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Measured: 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
An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: 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
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Measured: From Dose 1 (at Month 0) up to study end (at Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study start9 Apr 2007
- Primary completion30 Nov 2007
- Study completion21 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453986
- Sponsor's protocol ID
- 109067
- Status last verified
- Nov 2016
- First submitted
- 28 Mar 2007
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Dbaibo G, Macalalad N, Aplasca-De Los Reyes MR, Dimaano E, Bianco V, Baine Y, Miller J. The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority study. Hum Vaccin Immunother. 2012 Jul;8(7):873-80. doi: 10.4161/hv.20211. Epub 2012 Apr 9.
PubMed 22485050Macalalad N et al. The candidate Meningococcal serogroups A, C, W-135, Y conjugate vaccine (MenACWY-TT) and the seasonal influenza virus vaccine are immunogenic with an acceptable safety profile when co-administered in adults. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM) Hamburg, Germany, May 26-29, 2010.
Aplasca-De Los Reyes MR, Dimaano E, Macalalad N, Dbaibo G, Bianco V, Baine Y, Miller J. The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults. Hum Vaccin Immunother. 2012 Jul;8(7):881-7. doi: 10.4161/hv.20212. Epub 2012 Apr 9.
PubMed 22485048
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lot-to-Lot Consistency, Non-Inferiority Versus Mencevax™ and Evaluation of the Co-Administration With Fluarix™ of GSK Biologicals' Meningococcal Vaccine GSK134612, in Healthy Subjects Aged 18 Through 55 Years of Age
- ClinicalTrials.gov ID
- NCT00453986
- Acronym / sponsor ID
- 109067
- Conditions
- Infections, Meningococcal
- Keywords
- immunogenicity, Meningococcal serogroups A, C, W-135 and/or Y disease, co-administration, meningococcal vaccine, lot-to-lot consistency, conjugate vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,352 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2007
- Primary completion
- 30 Nov 2007 (actual)
- Study completion
- 21 May 2008 (actual)
- First posted
- 29 Mar 2007 (estimated)
- Results
- Posted 22 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group.
Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nimenrix A Group | Experimental | Biological: Meningococcal vaccine GSK134612subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. |
| Nimenrix B Group | Experimental | Biological: Meningococcal vaccine GSK134612subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. |
| Nimenrix C Group | Experimental | Biological: Meningococcal vaccine GSK134612subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. |
| Mencevax ACWY Group | Active comparator | Biological: Mencevax™ACWYsubjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm. |
| Nimenrix+Fluarix Group | Experimental | Biological: Meningococcal vaccine GSK134612, Biological: Fluarix™subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal vaccine GSK134612One intramuscular dose | Biological | Nimenrix A Group, Nimenrix B Group, Nimenrix C Group, Nimenrix+Fluarix Group |
| Mencevax™ACWYOne subcutaneous dose | Biological | Mencevax ACWY Group |
| Fluarix™One intramuscular dose | Biological | Nimenrix+Fluarix Group |
Primary outcome
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.
Time frame: One month after vaccination (at Month 1)
Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
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.
Time frame: One month after vaccination (at Month 1)
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
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)
Time frame: One month after vaccination (at Month 1)
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Time frame: One month after vaccination (at Month 1)
Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain. Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Time frame: One month after vaccination (at Month 1)
Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1)
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
30 secondary outcomes
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22485050Dbaibo G, Macalalad N, Aplasca-De Los Reyes MR, Dimaano E, Bianco V, Baine Y, Miller J. The immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority study. Hum Vaccin Immunother. 2012 Jul;8(7):873-80. doi: 10.4161/hv.20211. Epub 2012 Apr 9.
- BackgroundMacalalad N et al. The candidate Meningococcal serogroups A, C, W-135, Y conjugate vaccine (MenACWY-TT) and the seasonal influenza virus vaccine are immunogenic with an acceptable safety profile when co-administered in adults. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM) Hamburg, Germany, May 26-29, 2010.
- Background: PubMed 22485048Aplasca-De Los Reyes MR, Dimaano E, Macalalad N, Dbaibo G, Bianco V, Baine Y, Miller J. The investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adults. Hum Vaccin Immunother. 2012 Jul;8(7):881-7. doi: 10.4161/hv.20212. Epub 2012 Apr 9.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal vaccine GSK134612, Mencevax™ACWY and Fluarix™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines, Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One month after vaccination (at Month 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453986, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.