Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-Valent Pneumococcal Polysaccharide Vaccine (Pneumo 23) - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169507

Purpose

Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.

Condition	Intervention	Phase
Prophylaxis Pneumococcal Vaccine	Biological: Pneumococcal (vaccine)	Phase III

MedlinePlus related topics: Memory

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Multicentric Open Study to Evaluate Immunological Memory Induced by 3-Dose Primary Vaccination Followed by Booster Dose of GSK Biologicals' 11-Valent Conjugate Pneumococcal Vaccine Compared to Unprimed Subjects by Giving 1 Dose of Aventis Pasteur's Pneumo 23

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).

Secondary Outcome Measures:

"Before Pneumo 23 administration: Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F & seropositivity (S+) status* (>= 0.05 µg/mL) * also measured 10-15 days after dose of Pneumo 23
Before and 10-15 days after dose of Pneumo 23: Antibody titers (opsono) to selected pneumococcal serotypes and S+ status (>= 8)
Occurrence of SAEs during study period
"

Estimated Enrollment:

100

Detailed Description:

Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23

Eligibility

Ages Eligible for Study:	31 Months to 57 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria: Male or female who participated in Undeca-Pn-010 study, were part of the blood subset and received 4 doses of GSK Biologicals' 11Pn-PD vaccine, or Havrix vaccine. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169507

Locations

Slovakia
GSK Investigational Site
Nova Dubnica, Slovakia, 018 51
GSK Investigational Site
Dubnica Nad Vahom, Slovakia, 018 41
GSK Investigational Site
Povazska Bystrica, Slovakia, 017 01
GSK Investigational Site
Puchov, Slovakia, 020 01

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications indexed to this study:

Schuerman L, Prymula R, Chrobok V, Dieussaert I, Poolman J. Kinetics of the immune response following pneumococcal PD conjugate vaccination. Vaccine. 2007 Mar 1;25(11):1953-61. Epub 2006 Dec 26.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104083
Study First Received:	September 12, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00169507
Health Authority:	Slovakia: State Institute for Drug Control

ClinicalTrials.gov processed this record on January 13, 2009