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Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine in 2, 4, 6 Months of Age

NCT03025750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2018-11-14

No results posted yet for this study

Summary

The trial is a phase III, non-inferiority, observer-blind, randomised, active controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (comparator vaccine). The vaccines will be administered at 2, 4 and 6 months of age.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

IPV-Al SSI

Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age

BIOLOGICAL

IPV SSI

Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Larix A/S

    collaborator INDUSTRY

  • Vaxtrials S.A.

    collaborator OTHER

  • AJ Vaccines A/S

    collaborator INDUSTRY

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Ingrid Kromann · Statens Serum Institut

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
54 Days
Max Age
75 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2017-11-14
Completion
2017-11-14

Countries

  • Panama

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 NCT03025750 on ClinicalTrials.gov