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

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ClinicalTrials.gov Identifier: NCT00260312
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : December 1, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Level of Immunity Against Poliovirus Infection Biological: Inactivated Polio Vaccine given at an accelerated schedule

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Study Start Date : August 2001
Estimated Study Completion Date : January 2003


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 2 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260312


Sponsors and Collaborators
Pan American Health Organization
World Health Organization
Institute Pedro Kouri, Ministry of Public Health (Cuba)
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Miguel Galindo, MD Ministry of Public Health, Cuba
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00260312     History of Changes
Other Study ID Numbers: 3827
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: January 2004

Keywords provided by Pan American Health Organization:
inactived
polio
vaccine
cuba
trial
randomized
eradication

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs