Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00158808

Purpose

To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine

Condition	Intervention	Phase
Prophylaxis of Diphtheria Tetanus Pertussis Hepatitis B Hib Diseases	Biological: Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib	Phase II

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, Active Control, Parallel Assignment
Official Title:	Assess the Immunogenicity &d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals’ DTPw-HBV/Hib Vaccine at 15-18 Mths of Age in Infants Previously Primed With the Same Vaccine

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine).

Secondary Outcome Measures:

"Immunology
At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)
Reactogenicity and Safety
 Occurrence of solicited symptoms during the specific follow-up period after the booster dose.
 Occurrence of unsolicited symptoms during the specific follow-up period after the booster dose .
 Occurrence of serious adverse events (SAEs) during the entire study period."

Estimated Enrollment:	192
Study Start Date:	January 2005

Detailed Description:

All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.

Eligibility

Ages Eligible for Study:	15 Months and older
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 of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion criteria for enrolment

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination."

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158808

Locations

Philippines
GSK Clinical Trials Call Center
Alabang, Philippines

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Study ID Numbers:	101477
Study First Received:	September 8, 2005
Last Updated:	September 28, 2006
ClinicalTrials.gov Identifier:	NCT00158808
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

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

Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B
DNA Virus Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009