Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00316147

Purpose

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

Condition	Intervention	Phase
Healthy Subjects Infant	Biological: DTPa-HBV-IPV/Hib vaccine	Phase III

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Tetanus Whooping Cough

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers

Secondary Outcome Measures:

1M post-dose 3, antibody levels against all antigens
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Serious adverse events (SAEs) for entire study

Estimated Enrollment:	224
Study Start Date:	December 2005

Detailed Description:

DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 & Haemophilus influenzae type b vaccine

Eligibility

Ages Eligible for Study:	6 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Born after a normal gestation period (between 36 and 42 weeks).
Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.

Exclusion Criteria:

Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine 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 prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316147

Locations

India
GSK Investigational Site
Baroda, India, 390 001
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Goa, India, 403202

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104005
Study First Received:	February 21, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00316147
Health Authority:	India: Drugs Controller General of India (DCGI)

Keywords provided by GlaxoSmithKline:

Prophylaxis
diphtheria
tetanus
pertussis

hepatitis B
poliomyelitis
Haemophilus influenza type b diseases

Study placed in the following topic categories:

Pentetic Acid
Hepatitis
Haemophilus influenzae
Poliomyelitis
Influenza, Human
Hepatitis B

Whooping Cough
Healthy
Diphtheria
Tetanus
Iron
Whooping cough

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents

Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009