NCT01709071

Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

Double Blind Dose - Escalation, Randomized, Controlled, Phase I-II Trial to Evaluate Safety and Immunogenicity of Three Doses of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pauline Verdijk · Other Government
• Sex: All
• Age: 56 Days – 63 Days
• Healthy volunteers: Accepted

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.

Detailed description

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI). * The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants. * The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-11-01
• Completion: 2013-05-01
• First posted: 2012-10-17
• Last updated: 2014-02-21

Locations

7 sites across 1 country: Poland