Immunogenicity and Safety of Meningococcal Vaccine GSK 13... | NCT01154088

Status Module

Label	Type	Intervention Names
Group A	Experimental	Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group B	Experimental	Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Group C	Active Comparator	Biological: Mencevax ACWY

Name	Type	Description	Arm Group Labels	Other Names
Mencevax ACWY	Biological	One dose, Subcutaneous injection	Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies	Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.	At Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.	At Month 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.	At Day 0 and at Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects must satisfy all of the following criteria at study entry:

Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
A male or female between, and including, 18 and 25 years of age 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.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
Previous vaccination with meningococcal conjugate vaccine.
Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
History of meningococcal disease.
Seropositive for HIV or HBsAg (for subjects in the Philippines only).
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 has been demonstrated.
History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
History of any neurologic disorders, including Guillain-Barré Syndrome.
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 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.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Panama City			Panama
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
23885033	Background	Lupisan S, Limkittikul K, Sosa N, Chanthavanich P, Bianco V, Baine Y, Van der Wielen M, Miller JM. Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years. Clin Vaccine Immunol. 2013 Oct;20(10):1499-507. doi: 10.1128/CVI.00162-13. Epub 2013 Jul 24.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
114248	Individual Participant Data Set	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
FG001	Nimenrix-B Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
BG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
BG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000390 BG001390 BG002390 BG0031170

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies

Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Mencevax Group only.

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Units	Counts
Participants	OG000358 OG001353 OG002357

Title

Denominators

Categories

rSBA-MenA

- ParticipantsOG000302
- ParticipantsOG001298
- ParticipantsOG002293

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.					Difference in vaccine response rate	5.42			2-Sided	95	-1.41	12.25					Non-Inferiority	Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.

Primary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers

Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Nimenrix-B Group only.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.

Posted

Count of Participants

Participants

At Day 0 and at Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Units	Counts
Participants

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.

Posted

Count of Participants

Participants

At Day 0 and Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Units	Counts
Participants

Secondary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 and at Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Units	Counts
Participants

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

Posted

Count of Participants

Participants

At Day 0 and at Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Secondary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Secondary

Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Units	Counts

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within 4-days (Days 0-3) post-vaccination

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within 4-days (Days 0-3) post-vaccination

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

Within 31-days (Days 0-30) post-vaccination

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group

Secondary

Number of Subjects With New Onset Chronic Illnesses (NOCI)

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

Within 31-days (Days 0-30) post-vaccination

ID	Title	Description
OG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
OG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nimenrix-A Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.	390	0	390	274	390
EG001	Nimenrix-B Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.	390	1	390	271	390
EG002	Mencevax Group	Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.	390	0	390	237	390

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG000208 affected386 at risk EG001210 affected384 at risk EG002141 affected383 at risk
Redness	General disorders	MedDRA 14.0	Systematic Assessment	EG00093 affected386 at risk EG00184 affected384 at risk EG00257 affected383 at risk
Swelling	General disorders	MedDRA 14.0	Systematic Assessment	EG00057 affected386 at risk EG00163 affected384 at risk EG00242 affected383 at risk
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG000117 affected386 at risk EG001110 affected384 at risk EG002115 affected383 at risk
Gastrointestinal	General disorders	MedDRA 14.0	Systematic Assessment	EG00050 affected386 at risk EG00143 affected384 at risk EG00245 affected383 at risk
Headache	General disorders	MedDRA 14.0	Systematic Assessment	EG000105 affected386 at risk EG001119 affected384 at risk EG002103 affected383 at risk
Temperature /(Orally)	General disorders	MedDRA 14.0	Systematic Assessment	EG00028 affected386 at risk EG00123 affected384 at risk EG00226 affected383 at risk

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections