Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
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
1 other identifier
interventional
1,352
2 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2007
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedStudy Start
First participant enrolled
April 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2008
CompletedResults Posted
Study results publicly available
May 22, 2012
CompletedSeptember 25, 2018
November 1, 2016
8 months
March 28, 2007
April 23, 2012
August 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
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.
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).
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.
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.
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.
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.
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.
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.
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
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
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.
Prior to and one month after vaccination (at Month 0 and Month 1).
- +25 more secondary outcomes
Study Arms (5)
Nimenrix A Group
EXPERIMENTALsubjects 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
EXPERIMENTALsubjects 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
EXPERIMENTALsubjects 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 COMPARATORsubjects 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
EXPERIMENTALsubjects 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.
Interventions
One intramuscular dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Beirut, 1107-2020, Lebanon
GSK Investigational Site
Cavite, 4114, Philippines
GSK Investigational Site
City of Muntinlupa, Philippines
GSK Investigational Site
Manila, Philippines
Related Publications (3)
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.
PMID: 22485050BACKGROUNDMacalalad 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.
BACKGROUNDAplasca-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.
PMID: 22485048BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 29, 2007
Study Start
April 9, 2007
Primary Completion
November 30, 2007
Study Completion
May 21, 2008
Last Updated
September 25, 2018
Results First Posted
May 22, 2012
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.