Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00325143

Purpose

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Diphtheria, Tetanus, Pertussis, Hepatitis B, Polio, Haemophilus Influenzae Type B	Biological: DTPa-HBV-IPV/Hib Biological: DTPa-IPV/Hib vaccine	Phase III

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Infanrix hexa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of solicited local and general adverse events [ Time Frame: During the 4-day follow up period after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of unsolicited local and general adverse events [ Time Frame: During the 30-day follow up period after vaccination ] [ Designated as safety issue: Yes ]
Occurrence of large swelling reactions [ Time Frame: After booster dose ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Enrollment:	702
Study Start Date:	December 2003
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: DTPa-HBV-IPV/Hib 1 intramuscular injection (3rd study vaccine dose) Biological: DTPa-IPV/Hib vaccine 3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Detailed Description:

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Eligibility

Ages Eligible for Study:	11 Weeks to 17 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria

Subjects must have been enrolled in the Rota-028 study.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion criteria

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
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: NCT00325143

Locations

Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 229899

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	217744/100
Study First Received:	February 8, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00325143
Health Authority:	Singapore: Singapore Regulatory Authority

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Haemophilus influenzae
Hepatitis, Viral, Human
Whooping Cough
Cough
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Pentetic Acid

Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Hepatitis B
Influenza, Human
DNA Virus Infections
Iron

Additional relevant MeSH terms:

Bordetella Infections
Molecular Mechanisms of Pharmacological Action
Corynebacterium Infections
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents

Infection
Protective Agents
Hepadnaviridae Infections
Pharmacologic Actions
Actinomycetales Infections
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009