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3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents

NCT02280447 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-11-14

No results posted yet for this study

Summary

The background of the 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 become available in low resource third World countries.

The primary objective of the phase I/II clinical trial is to provide proof of concept (POC) that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI.

A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months and 5 years of age according to the Danish vaccination program will be included in the trial.

Conditions

  • Immunization, Booster

Interventions

BIOLOGICAL

1/3 IPV-Al SSI, manufactured by SSI, Denmark

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

BIOLOGICAL

1/5 IPV-Al SSI, manufactured by SSI, Denmark

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

BIOLOGICAL

1/10 IPV-Al SSI, manufactured by SSI, Denmark

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

BIOLOGICAL

IPV SSI, manufactured by SSI, Denmark

Intramuscular injection of 0.5 mL vaccine into deltoid muscle

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • CCBR Clinical Research

    collaborator UNKNOWN

  • Larix A/S

    collaborator INDUSTRY

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Line Markdanner Lindgren · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-13
Primary Completion
2015-03-31
Completion
2015-03-05

Countries

  • Denmark

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 NCT02280447 on ClinicalTrials.gov