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)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169507
First received: September 12, 2005
Last updated: September 29, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Study Start Date: March 2005
Intervention Details:
    Biological: Pneumococcal (vaccine)
    Other Name: Pneumococcal (vaccine)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00169507

Locations
Slovakia
GSK Investigational Site
Dubnica Nad Vahom, Slovakia, 018 41
GSK Investigational Site
Nova Dubnica, Slovakia, 018 51
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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00169507     History of Changes
Other Study ID Numbers: 104083
Study First Received: September 12, 2005
Last Updated: September 29, 2011
Health Authority: Slovakia: State Institute for Drug Control

ClinicalTrials.gov processed this record on October 01, 2014