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Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants

NCT00624975 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-08-01

No results posted yet for this study

Summary

The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.

Conditions

Interventions

BIOLOGICAL

Peru-15 Vaccine

up to 1 x 10\^9 CFU of Peru-15 given in 5ml single dose vials with 20 ml buffer solution, given once

BIOLOGICAL

Placebo

25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water)

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • Avant Immunotherapeutics

    collaborator INDUSTRY

  • Vaccine Technologies Inc.

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • John Clemens, MD · International Vaccine Insititute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Bangladesh
  • India

Study Locations

More Related Trials

Entities

Drugs
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 NCT00624975 on ClinicalTrials.gov