A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

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ClinicalTrials.gov Identifier: NCT00317174

Recruitment Status : Completed

First Posted : April 24, 2006

Last Update Posted : September 9, 2016

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Haemophilus Influenzae Type b Tetanus Whole Cell Pertussis Hepatitis B Diphtheria	Biological: DTPw-HBV/Hib-MenAC conjugate vaccine	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	450 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Study Start Date :	July 2003
Actual Study Completion Date :	April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections

Genetic and Rare Diseases Information Center resources: Diphtheria Whooping Cough Tetanus Haemophilus Influenzae

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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)

Eligibility Criteria

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Ages Eligible for Study:	10 Months and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317174

Locations


Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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