Trial intelligence / Profile preview

PCV13 Safety and Immunogenicity in Alaskan Native Children

NCT00743652Phase 3

Key facts

Status: Completed
Start: Jan 2009
Primary completion: Sep 2010
Countries: 1
Sponsor: Pfizer
Modality: Vaccines & Immunotherapeutics

Drugs: Prevnar 13
Conditions: pneumococcal disease

Overview

Phase 3, open-label trial of Prevnar 13 in pneumococcal disease (5 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >= 0.35 Micrograms Per Milliliter (Mcg/mL). Started Jan 2009; status: completed.

Design

5 arms

Study design: Non-randomizedOpen-label

Group 1
Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar. 4 doses of 13vPnC.
Group 2
Subjects <12 months of age with 1 prior dose of Prevnar. 3 doses of 13vPnC.
Group 3
Subjects <12 months of age with 2 prior doses of Prevnar. 2 doses of 13vPnC.
Group 4
Subjects 12 months to <2 years of age. 2 doses of 13vPnC.
Group 5
Subjects 2 years to <5 years of age. 1 dose of 13vPnC.

Who it enrols

Healthy Alaskan Native children aged 6 weeks to 5 years living in the Yukon Kuskokwim Delta region.

Endpoints

Primary

Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >= 0.35 Micrograms Per Milliliter (Mcg/mL)1 month after catch-up dose

Secondary

Percentage of Participants Achieving Serum IgG Antibody Level >= 0.35 Mcg/mL Prior to Vaccination With 13vPnCPrior to vaccination
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >= 1.0 Mcg/mL1 month after catch-up dose
Percentage of Participants Reporting Pre-Specified Local ReactionsDay 1 through Day 7 after vaccination
Percentage of Participants Reporting Pre-Specified Systemic EventsDay 1 through Day 7 after vaccination

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