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PCV10 Reactogenicity and Immunogenicity Study - Malindi

NCT01028326 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-02-23

No results posted yet for this study

Summary

The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.

Conditions

  • Pneumococcal Pneumonia

Interventions

BIOLOGICAL

PCV10 and DTaP

A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.

BIOLOGICAL

PCV10 and DTaP

A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 180 and a 0.5 mL dose of DTaP on day 60.

BIOLOGICAL

hepatitis A vaccine, DTaP, PCV10

A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.

Sponsors & Collaborators

  • Kenya Ministry of Health

    collaborator OTHER_GOV

  • University of Oxford

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • KEMRI-Wellcome Trust Collaborative Research Program

    lead OTHER

Principal Investigators

  • Laura Hammitt, MD · Oxford University, KEMRI-Wellcome Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2018-12-31

Countries

  • Kenya

Study Locations

More Related Trials

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 NCT01028326 on ClinicalTrials.gov