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

NCT00317174 | Completed Phase 2

• 1 other identifier: 759346/002
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilus Influenzae Type b; Tetanus; Whole Cell Pertussis; Hepatitis B; Diphtheria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Interventions

DTPw-HBV/Hib-MenAC conjugate vaccine BIOLOGICAL

Eligibility Criteria

• Age: 10 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

Related Publications (1)

• Gatchalian S, Palestroque E, De Vleeschauwer I, Han HH, Poolman J, Schuerman L, Dobbelaere K, Boutriau D. The development of a new heptavalent diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C vaccine: a randomized dose-ranging trial of the conjugate vaccine components. Int J Infect Dis. 2008 May;12(3):278-88. doi: 10.1016/j.ijid.2007.08.007. Epub 2007 Nov 5.

  PMID: 17981067 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Haemophilus Infections; Tetanus; Hepatitis B; Diphtheria

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Gram-Positive Bacterial Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Corynebacterium Infections; Actinomycetales Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: April 24, 2006
• Study Start: July 1, 2003
• Study Completion: April 1, 2004
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

PH (1)