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Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children

NCT01619462 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-03-21

No results posted yet for this study

Summary

The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.

Conditions

Interventions

BIOLOGICAL

Prevenar 13 and Synflorix

260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • Papua New Guinea Institute of Medical Research

    lead OTHER_GOV

Principal Investigators

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

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

  • Peter Richmond, MD · The University of Western Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
35 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-04-30
Completion
2016-11-30

Countries

  • Papua New Guinea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01619462 on ClinicalTrials.gov