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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine

NCT00454987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2020-06-16

Study results available
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Summary

The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorixâ„¢, given at 12-15 months of age. The children had previously received 3 doses of Menitorixâ„¢ and Infanrix IPVâ„¢ or Meningitecâ„¢ and Pediacelâ„¢ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life.

This protocol posting deals with objectives \& outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase \& booster phase at 12 to 15 months are provided below:

https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis
  • Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine

Interventions

BIOLOGICAL

Menitorix

Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.

BIOLOGICAL

Infanrix IPV

Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
64 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-16
Primary Completion
2007-10-12
Completion
2007-10-12

Countries

  • Poland
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454987 on ClinicalTrials.gov