Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00453986

Purpose

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.

Condition	Intervention	Phase
Meningococcal Infection	Biological: Fluarix™ Biological: Meningococcal vaccine GSK134612 Biological: Mencevax™ACWY	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy 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

Resource links provided by NLM:

Drug Information available for: Fluvirin Influenza Vaccines Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Meningococcal rSBA titres in Groups A, B and C [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
Vaccine response to meningococcal antigens in pooled Groups A, B & C and in Group D [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
Meningococcal rSBA titres in Groups A and E [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
Serum haemagglutination-inhibition (HI) antibody titres, seroconversion rates, conversion factors, and seroprotection rates against each of the 3 influenza virus strains represented in the vaccine in Group E. [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Meningococcal rSBA titres [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
Vaccine response to meningococcal antigens [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
Anti-Tetanus toxoid antibody concentrations [ Time Frame: Prior to and one month after vaccination, in all subjects ] [ Designated as safety issue: No ]
Anti-meningococcal polysaccharide concentrations [ Time Frame: Prior to and one month after vaccination, in a randomized subset of subjects ] [ Designated as safety issue: No ]
Serum haemagglutination-inhibition (HI) antibody titres, tested separately against each of the 3 influenza strains represented in the vaccine, to provide the seroconversion and seroprotection rates as derived variables [ Time Frame: Prior to and one month after vaccination in Group E ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses [ Time Frame: Up to six months after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of any grade 3 systemic symptoms in the pooled data of this study and study 109069 [ Time Frame: During the 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	1352
Study Start Date:	April 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Meningococcal vaccine GSK134612 Lot A	Biological: Meningococcal vaccine GSK134612 One intramuscular dose
Group B: Experimental Meningococcal vaccine GSK134612 Lot B	Biological: Meningococcal vaccine GSK134612 One intramuscular dose
Group D: Active Comparator Mencevax™ ACWY	Biological: Mencevax™ACWY One subcutaneous dose
Group E: Experimental Meningococcal vaccine GSK134612 Lot A co-administered with Fluarix™	Biological: Fluarix™ One intramuscular dose Biological: Meningococcal vaccine GSK134612 One intramuscular dose
Group C: Experimental Meningococcal vaccine GSK134612 Lot C	Biological: Meningococcal vaccine GSK134612 One intramuscular dose

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

For all subjects:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 55 years of age at the time of the vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of his/her knowledge.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test, and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

For all subjects:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y within the last five previous years.
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
Previous vaccination with tetanus toxoid within the last month.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination..
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Additional criteria for subjects receiving Fluarix™ co-administration:

History of hypersensitivity to a previous dose of influenza vaccine.
History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate.
History of administration of an influenza vaccine outside of this study, during current flu season.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453986

Locations

Lebanon
GSK Investigational Site
Beirut, Lebanon, 1107-2020
Philippines
GSK Investigational Site
Manila, Philippines
GSK Investigational Site
Cavite, Philippines, 4114
GSK Investigational Site
Muntinlupa, Philippines

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109067
Study First Received:	March 28, 2007
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00453986 History of Changes
Health Authority:	Lebanon: Ministry of Public Health

Keywords provided by GlaxoSmithKline:

meningococcal vaccine
lot-to-lot consistency
immunogenicity

conjugate vaccine
co-administration
Meningococcal serogroups A, C, W-135 and/or Y disease

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Healthy

Meningococcal Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 10, 2009