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Pneumococcal Conjugate Vaccine Followup

NCT01414504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2012-09-17

No results posted yet for this study

Summary

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.

Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.

Conditions

  • Immune Tolerance

Interventions

BIOLOGICAL

Prevenar + PPV

0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs

BIOLOGICAL

Infant PCV (Prevenar) + PPV at 9 months

0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs

BIOLOGICAL

No Prevenar + PPV at 9 months

no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs

BIOLOGICAL

Control

control, 0.1mL Pneumovax at 3-5yrs

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • William Pomat

    lead OTHER_GOV

Principal Investigators

  • Peter C Richmond, MD · School of Paediatrics and Child Health, University of Western Australia

  • Deborah Lehmann, MSc · Telethon Institute for Child Health Research

  • William S Pomat, PhD · Papua New Guinea Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30
Completion
2012-09-30

Countries

  • Papua New Guinea

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 NCT01414504 on ClinicalTrials.gov