NCT00624819

Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

Long-term Follow-up Study to Assess Antibody Persistence in Children Previously Vaccinated With Four Doses of Pneumococcal Conjugate Vaccine in Primary Vaccination Study (105553) and Booster Vaccination Study (107046)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 28 Months – 32 Months
• Healthy volunteers: Accepted

Summary

This protocol posting deals with objectives \& outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

Detailed description

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Conditions

• Infections, Streptococcal
• Streptococcus Pneumoniae Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	GSK1024805A	No vaccination in this trial
BIOLOGICAL	Prevenar	No vaccination in this trial
BIOLOGICAL	Infanrix hexa	No vaccination in this trial
BIOLOGICAL	Havrix	No vaccination in this trial
BIOLOGICAL	Varilrix	No vaccination in this trial

Timeline

• Start date: 2008-03-03
• Primary completion: 2008-06-02
• Completion: 2008-06-02
• First posted: 2008-02-27
• Last updated: 2021-01-27
• Results posted: 2020-03-18

Locations

6 sites across 1 country: Poland