Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-Valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-Valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

This study has been completed.

First Received: March 7, 2006 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00307567

Purpose

Booster and immune memory study

Condition	Intervention	Phase
Pneumococcal Disease	Biological: Pneumococcal (vaccine)	Phase II

MedlinePlus related topics: Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate Booster Vaccination With GSK Biologicals' 10-Valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following a Single Dose of 23-Valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 103488

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,

Secondary Outcome Measures:

Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Ab concentrations to protein D & seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Occurrence of: solicited local*,general *symptoms within 4 d
Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster

Estimated Enrollment:

689

Detailed Description:

Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib

Eligibility

Ages Eligible for Study:	11 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307567

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Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105555
Study First Received:	March 7, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00307567 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009