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Completed

NCT Number: NCT00260312

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

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.

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Key information

Conditions

Level of Immunity Against Poliovirus Infection Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

6 week–2 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Inactivated Polio Vaccine given at an accelerated schedule

Biological

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pan American Health Organization

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Institute Pedro Kouri, Ministry of Public Health (Cuba)
  • World Health Organization

Registry information

Official study title

Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba

Important dates

Study start
2001
Study completion
2003
First posted
Dec 1, 2005
Registry last updated
Dec 1, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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