A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00317174

Purpose

The purpose of the study is as follows:

To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects.
To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Hib Disease Neisseria Meningitidis Serogroup Diseases	Biological: DTPw-HBV/Hib-MenAC conjugate vaccine	Phase II

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Memory Tetanus Whooping Cough

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assess Immune Persistence & Memory by Giving Plain PRP,PSA & PSC (10 Mths Age), & Immunogenicity & Safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 Booster (15-18 Mths Age) in Previously Primed Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.

Secondary Outcome Measures:

Pre & 1M post-DTP booster (subset of subjects), antibody levels for all vaccine antigens. Retrospective serious adverse events (SAEs). Solicited (day 0-7), unsolicited events (day 0-30). SAEs (entire study)

Estimated Enrollment:	450
Study Start Date:	July 2003

Detailed Description:

This study will be conducted in two stages:

At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age.

At 15 to 18 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.

Eligibility

Ages Eligible for Study:	10 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

• Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents.

Exclusion criteria:

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).
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period.
Chronic administration (> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001.
History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317174

Locations

Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	759346/002
Study First Received:	February 15, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00317174
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
Neisseria meningitidis
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

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

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009