Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00290342

Purpose

DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Diphtheria, Tetanus, Pertussis, Poliomyelitis	Biological: DTPa Biological: IMOVAX Polio® Biological: DTPa-IPV	Phase III

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. co-Administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-diphtheria antibody concentration [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Anti-tetanus antibody concentration [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Anti-poliovirus type 1 titre [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Anti- poliovirus type 2 titre [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Anti- poliovirus type 3 titre [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Anti-pertussis antibody concentrations [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Vaccine response to pertussis antigens [ Time Frame: One month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Geometric mean concentration or titre of antibodies for all vaccine antigens [ Time Frame: Before and one month after the three-dose primary vaccination course ] [ Designated as safety issue: No ]
Occurrence of solicited local adverse events [ Time Frame: During the 4 day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of solicited general adverse events [ Time Frame: During the 4 day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited local and general adverse events [ Time Frame: During the 31-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Enrollment:	452
Study Start Date:	January 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator	Biological: DTPa 3 intramuscular injections Biological: IMOVAX Polio® 3 intramuscular injections
Group A: Experimental	Biological: DTPa-IPV 3 intramuscular injections

Detailed Description:

Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.

Eligibility

Ages Eligible for Study:	8 Weeks to 12 Weeks
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, 8 and 12 weeks (56-90 days) of age at the time of the first 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.
Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 since birth.
Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
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 against diphtheria, tetanus, pertussis and/or poliovirus disease.
History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290342

Locations

Korea, Republic of
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 420-767
GSK Investigational Site
Jeonju, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
GSK Investigational Site
Kwangju, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 150-030
GSK Investigational Site
Incheon, Korea, Republic of

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104871
Study First Received:	February 10, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00290342
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Healthy
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Neuromuscular Diseases
Motor Neuron Disease
Cough

Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Degenerative motor system disease
Motor neuron disease
Virus Diseases
Pentetic Acid
Central Nervous System Infections
Poliomyelitis
Myelitis
Enterovirus Infections
Iron

Additional relevant MeSH terms:

RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Iron Chelating Agents
Central Nervous System Viral Diseases
Infection

Protective Agents
Actinomycetales Infections
Pharmacologic Actions
Bordetella Infections
Corynebacterium Infections
Chelating Agents
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009