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Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months

NCT03032419 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2018-11-14

No results posted yet for this study

Summary

The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

IPV-Al SSI

3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

BIOLOGICAL

IPV SSI

3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Larix A/S

    collaborator INDUSTRY

  • Syneos Health

    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
6 Weeks
Max Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-09-21
Completion
2018-03-12

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Companies

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 NCT03032419 on ClinicalTrials.gov