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13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

NCT01095471 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-03-22

No results posted yet for this study

Summary

This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12 months of age. We intend to recruit all interested participants who completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those that recruited the majority of the children in the original study). The study will start in March 2010, at which time the eldest participants in the 6096A1-007 study will be approximately 42 months of age. There will be two visits per participant, 1 month apart from each other. At visit one, all participants will have a blood test and receive a dose of PCV13. At visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.

Conditions

  • Pneumococcal Disease

Interventions

BIOLOGICAL

PCV13

Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • University of Southampton

    collaborator OTHER

  • University of London

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew Pollard, FRCPCH, PhD · University of Oxford, Department of Paediatrics

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
39 Months
Max Age
46 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United Kingdom

Study Locations

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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 NCT01095471 on ClinicalTrials.gov