Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01708720 |
Recruitment Status
:
Completed
First Posted
: October 17, 2012
Last Update Posted
: February 21, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Poliomyelitis | Drug: IPV Drug: Sabin-IPV Drug: Adjuvanted Sabin-IPV | Phase 1 |
The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).
- The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).
- The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Sabin-IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, and 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose
|
Drug: Sabin-IPV |
Experimental: Adjuvanted Sabin-IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, and 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose, adjuvanted with 0.5 mg aluminium hydroxide
|
Drug: Adjuvanted Sabin-IPV |
Active Comparator: IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose
|
Drug: IPV
Other Names:
|
- Number of adverse reactions following vaccination [ Time Frame: 4 days or until adverse reactions have resolved ]
- Level of virus neutralizing titers in serum [ Time Frame: 28 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18 to 49, inclusive at the time of enrolment
- in good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the investigator
- Male
- Must have received polio vaccinations with OPV according to the Polish National Immunization Program as a child based on vaccination cards or information given by subjects during interview with investigator
- Preferred: number (and date) of polio vaccinations known
- Willingness and ability to adhere to the study regimen
- Having a signed informed consent form
Exclusion Criteria:
- IPV or OPV booster dose after the age of 12 years
- Positive for HIV, Hepatitis B or Hepatitis C
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Known or suspected disease or use of medication that may influence the immune system
- Known or suspected immune deficiency
- Systemic treatment with corticosteroids within one month before screening
- Administration of plasma (including immunoglobulins) or blood products three months prior to the study
- Blood donation within one month before screening
- Any vaccination within three months before screening and during the study until the last visit
- History of any neurological disorder including epilepsy or febrile seizures
- Evidence of excessive alcohol use or drug use
- Any infectious disease at the time of screening and/or inclusion
- Participation in another clinical trial within three months before screening
- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- Bleeding disorders or the usage of anticoagulants

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): NCT01708720
Poland | |
Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o. | |
Krakow, Poland |
Study Director: | Pauline Verdijk, PhD | Institute for Public Health and the Environment |
Publications of Results:
Other Publications:
Responsible Party: | Pauline Verdijk, Clinical Research Scientist, Institute of Public Health and the Environment |
ClinicalTrials.gov Identifier: | NCT01708720 History of Changes |
Other Study ID Numbers: |
NVI-256A 2010-024581-22 ( EudraCT Number ) |
First Posted: | October 17, 2012 Key Record Dates |
Last Update Posted: | February 21, 2014 |
Last Verified: | February 2014 |
Keywords provided by Pauline Verdijk, Institute of Public Health and the Environment:
Vaccination Inactivated Poliomyelitis Vaccine Polio Sabin |
Additional relevant MeSH terms:
Poliomyelitis Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Myelitis Central Nervous System Infections |
Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |