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IPV Clinical Trial - The Gambia

NCT01847872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2018-03-22

No results posted yet for this study

Summary

The overall goal of this study is to identify interference between intramuscular Inactivated Polio Vaccine (IPV) and other vaccines (Measles Rubella and Yellow Fever) co-administered at nine months of age and to confirm the safety of co-administration. In addition, the study will compare the immunogenicity and safety of IPV when administered via different routes.

A total of 1504 healthy infants between the ages of nine to ten months, who have completed their primary immunizations, including at least three doses of trivalent Oral Polio Vaccine (tOPV) will be recruited for this study.

Conditions

  • Poliomyelitis

Interventions

DRUG

IPV IM Needle

DRUG

IPV ID Needle

DRUG

IPV IM Device

DRUG

IPV ID Device

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Ed Clarke, MD · Medical Research Council Unit, The Gambia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-04-30
Completion
2015-07-31

Countries

  • The Gambia

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 NCT01847872 on ClinicalTrials.gov