MedTrace Logo

Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

NCT01709071 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-02-21

No results posted yet for this study

Summary

A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.

Conditions

  • Poliomyelitis

Interventions

DRUG

IPV

DRUG

Low dose Sabin-IPV

DRUG

Low dose adjuvanted Sabin-IPV

DRUG

Middle dose Sabin-IPV

DRUG

Middle dose adjuvanted Sabin-IPV

DRUG

High dose Sabin-IPV

DRUG

High dose adjuvanted Sabin-IPV

Sponsors & Collaborators

Principal Investigators

  • Pauline Verdijk, PhD · National Institute for Public Health and the Environment (RIVM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
56 Days
Max Age
63 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Poland

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 NCT01709071 on ClinicalTrials.gov