Completed

NCT Number: NCT00169507

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)

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.

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Key information

Conditions

Prophylaxis Pneumococcal Vaccine

Age range

31 month–57 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Dubnica nad Váhom, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pneumococcal (vaccine)

Biological

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.