Study of New Formulation of Infanrix Hexa Administered as a Booster Dose to 18-23 Months Old Children - Full Text View

Purpose

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type b Disease	Biological: Infanrix hexa	Phase IV

MedlinePlus related topics:

Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough

ChemIDplus related topics:

Hepatitis B Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Official Title:	Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-PRP antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-poliovirus type 1, 2 and 3 titers [ Time Frame: One month after the booster dose ]
Anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: One month after the booster dose ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-PRP antibody concentrations [ Time Frame: One month after the booster dose ]
Anti-PT, anti-FHA and anti-PRN seropositivity [ Time Frame: One month after the booster dose ]
Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 antibody concentrations or titres [ Time Frame: One month after the booster dose ]
Anti-HBs antibody concentrations [ Time Frame: Before the booster dose ]
Anti-PRP antibody concentrations [ Time Frame: Before the booster dose ]
Anti-diphtheria antibody concentrations [ Time Frame: Before the booster dose ]
Anti-tetanus antibody concentrations [ Time Frame: Before the booster dose ]
Anti-poliovirus type 1 titers [ Time Frame: Before the booster dose ]
Anti-poliovirus type 2 titers [ Time Frame: Before the booster dose ]
Anti-poliovirus type 3 titers [ Time Frame: Before the booster dose ]
Anti-PT, anti-FHA and anti-PRN seropositivity [ Time Frame: Before the booster dose ]
Anti-HBs, anti-PRP, anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3, anti-PT, anti-FHA and anti-PRN antibody concentrations or titres. [ Time Frame: Before the booster dose ]
Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period ]
Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period ]
Occurrence of SAEs [ Time Frame: Following booster vaccination ]

Estimated Enrollment:	320
Study Start Date:	February 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 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 should be enrolled in the study.
Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study 105910.
A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
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 booster 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 the booster dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
Participation in another clinical study, between the primary study 105910 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study 105910.
Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study 105910.
History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study 105910.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination .
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611559

Locations


Russian Federation
	GSK Investigational Site
	Perm, Russian Federation, 614022
	GSK Investigational Site
	Murmansk, Russian Federation, 183046
	GSK Investigational Site
	Syktyvkar, Russian Federation, 167000

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110478
First Received:	January 29, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00611559
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by GlaxoSmithKline:

Infanrix hexa

Diphtheria

Tetanus

Pertussis

Hepatitis B

Hib

Study placed in the following topic categories:

Bacterial Infections

Liver Diseases

Spinal Cord Diseases

Whooping Cough

Hepatitis, Viral, Human

Orthomyxoviridae Infections

Tetanus

Whooping cough

Gram-Negative Bacterial Infections

Gram-Positive Bacterial Infections

Neuromuscular Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Hepatitis B

Motor Neuron Disease

Haemophilus influenzae

Cough

Picornaviridae Infections

Central Nervous System Diseases

Degenerative motor system disease

Diphtheria

Motor neuron disease

Hepatitis

Virus Diseases

Digestive System Diseases

Central Nervous System Infections

Poliomyelitis

Influenza, Human

DNA Virus Infections

Myelitis

Additional relevant MeSH terms:

Bordetella Infections

RNA Virus Infections

Corynebacterium Infections

Nervous System Diseases

Central Nervous System Viral Diseases

Infection

Hepadnaviridae Infections

Actinomycetales Infections

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00611559