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

Pauline Verdijk7 sites in 1 country140 target enrollmentStarted: February 2012Last updated: February 21, 2014

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 140
Locations: 7
Primary Endpoint: Number of adverse reactions following vaccination

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 56 Days to 63 Days (Child)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Age 8 weeks (56-63 days) at the time of first vaccination
•Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
•The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
•Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion Criteria

•Any IPV or OPV dose
•Known or suspected allergy against any of the vaccine components
•History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
•Any vaccination less than 14 days before or after each vaccination with the IMP
•History of any neurological disorder including epilepsy or febrile seizures
•Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
•Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
•Any known or suspected primary or secondary immunodeficiency
•Communication problems interfering in the study realization according to the judgment of the investigator
•Bleeding disorders and use of anticoagulants
•Premature birth (<37 weeks)
•Participation in another clinical trial

Arms & Interventions

Low dose Sabin-IPV

Experimental

Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose.