Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-01-31

Brief Summary

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The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

Detailed Description

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After polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only limited data are available on IPV immunogenicity in tropical developing countries, we conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. Target sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (OPV)recieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine.

Conditions

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Level of Immunity Against Poliovirus Infection

Keywords

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inactived polio vaccine cuba trial randomized eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Inactivated Polio Vaccine given at an accelerated schedule

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).

Born healthy at one of the 4 designated maternity hospitals in Cuba

Exclusion Criteria

Serious congenital defect/disease at birth

\-

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

2 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Miguel Galindo, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Public Health, Cuba

References

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Cuba IPV Study Collaborative Group. Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. doi: 10.1056/NEJMoa054960.

Reference Type DERIVED

PMID: 17429085 (View on PubMed)

Other Identifiers

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3827

Identifier Type: -

Identifier Source: org_study_id