Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00758264

Purpose

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

Condition	Intervention	Phase
Meningococcal Disease Pneumococcal Disease.	Biological: Meningococcal vaccine GSK134612 Biological: Pneumococcal vaccine GSK1024850A	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A

Resource links provided by NLM:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Meningococcal Vaccines Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-pneumococcal antibody concentrations in Groups A and B [ Time Frame: One month after first vaccine dose. ] [ Designated as safety issue: No ]
Meningococcal serum bactericidal assay titres in Groups A and C. [ Time Frame: One month after first vaccine dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-pneumococcal antibody concentrations. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Opsonophagocytic activity/titres against pneumococcal serotypes.. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Anti-PD antibody concentrations. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Meningococcal serum bactericidal assay titres. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Anti-meningococcal polysaccharide concentrations. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Anti-tetanus toxoid antibody concentrations. [ Time Frame: Prior to and one month after each vaccine administration. ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms (any and grade 3). [ Time Frame: Within 4 days after each vaccination. ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms. [ Time Frame: Within 31 days after each vaccination. ] [ Designated as safety issue: No ]
Occurrence of serious adverse events. [ Time Frame: Throughout the entire study duration. ] [ Designated as safety issue: No ]
Occurrence of specific adverse events of rash, new onset of chronic illness(es), conditions prompting emergency room visits and physician office visits not related to common illnesses and/or any event(s) related to lack of vaccine efficacy. [ Time Frame: Throughout the entire study duration. ] [ Designated as safety issue: No ]

Enrollment:	363
Study Start Date:	October 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.	Biological: Meningococcal vaccine GSK134612 Single dose intramuscular injection. Biological: Pneumococcal vaccine GSK1024850A Single dose intramuscular injection.
Group A: Experimental Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.	Biological: Meningococcal vaccine GSK134612 Single dose intramuscular injection. Biological: Pneumococcal vaccine GSK1024850A Single dose intramuscular injection.
Group C: Active Comparator Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.	Biological: Meningococcal vaccine GSK134612 Single dose intramuscular injection. Biological: Pneumococcal vaccine GSK1024850A Single dose intramuscular injection.

Detailed Description:

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine. All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)

Eligibility

Ages Eligible for Study:	12 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), 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 first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
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 (pharmaceutical product or device).
Previous vaccination with a meningococcal vaccine.
Previous administration of a fourth dose of a pneumococcal vaccine
Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
History of meningococcal or pneumococcal invasive disease.
History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758264

Locations

Mexico
GSK Investigational Site
Mexico city, Mexico, 14000
GSK Investigational Site
Mexico, Mexico, 14080
Taiwan
GSK Investigational Site
Taoyuan Hsien, Taiwan
GSK Investigational Site
Taipei, Taiwan, 105
GSK Investigational Site
Taipei, Taiwan, 100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111393
Study First Received:	September 23, 2008
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00758264 History of Changes
Health Authority:	Mexico: Ministry of Health; Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:

Meningococcal vaccine
Pneumococcal vaccine
Routine infancy vaccination
Immunogenicity
Safety

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
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 11, 2009