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3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants

NCT02347423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2018-11-14

No results posted yet for this study

Summary

The background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third world countries. The intention of the present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the target population and do not decrease the immunogenicity clinically significantly compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of age.

A total of 824 healthy infants will be included in the trial.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI

BIOLOGICAL

IPV Vaccine SSI

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Larix A/S

    collaborator INDUSTRY

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Ingrid Kromann · Statens Serum Institut

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
49 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-09-30
Completion
2015-09-26

Countries

  • Dominican Republic

Study Locations

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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 NCT02347423 on ClinicalTrials.gov