Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169442

Purpose

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 – 18 months of age.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Hib Diseases	Biological: Diphtheria, tetanus, pertussis, hepatitis B & Hib	Phase III

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Memory 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:	Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

"In the groups receiving Plain PRP at 10 months of age:
One month after the administration of Plain PRP: anti-PRP antibody concentrations
In the groups receiving DTPw-HBV/Hib or DTPw-HBV + Hib at 15-18 months of age:
One month after the administration of the booster: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens)"

Secondary Outcome Measures:

"Immunogenicity
In the groups receiving Plain PRP at 10 months of age:
Prior to receiving Plain PRP: Anti-PRP antibody concentration
In the groups receiving DTPw-HBV/Hib or DTPw-HBV + Hib at 15-18 months of age:
Prior to receiving 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 (within the specific follow up period after vaccination)
 Occurrence of unsolicited symptoms (within the specific follow-up after vaccination)
 Occurrence of SAEs over the full course of the study."

Estimated Enrollment:	765
Study Start Date:	February 2005

Detailed Description:

" Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.

Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.
Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster."

Eligibility

Ages Eligible for Study:	10 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

"Inclusion criteria:

For subjects receiving Plain PRP followed by DTPw-HBV:

Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For all subjects:

Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
Free of obvious health problems as established by medical history and clinical examination

Exclusion criteria:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine."

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169442

Locations

Philippines
GSK Clinical Trials Call Center
Muntinlupa city, Philippines

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Study ID Numbers:	104065
Study First Received:	September 12, 2005
Last Updated:	September 28, 2006
ClinicalTrials.gov Identifier:	NCT00169442
Health Authority:	Philippines: Department of Health

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 13, 2009