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Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine

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: NCT02291263
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 27, 2015
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief Summary:
This study will be an open-label phase III randomized clinical trial comparing different combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also receive bOPV at 6, 10 and 14 weeks of age.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: bOPV/IPV (6 weeks) Biological: bOPV/IPV (14 weeks) Biological: bOPV/IPV (6 & 14 weeks) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine Against Type 2 With Bivalent Oral Poliovirus Vaccine in Routine Immunization
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Active Comparator: Arm A
Group A will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group A participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.
Biological: bOPV/IPV (6 weeks)
bOPV at 6, 10 and 14 weeks of age IPV at 6 weeks of age

Active Comparator: Arm B
Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group B participants will also receive inactivated polio vaccine (IPV) at 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.
Biological: bOPV/IPV (14 weeks)
bOPV at 6, 10 and 14 weeks of age IPV at 14 weeks of age

Active Comparator: Arm C
Group C will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group C participants will also receive inactivated polio vaccine (IPV) at 6 and 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.
Biological: bOPV/IPV (6 & 14 weeks)
bOPV at 6, 10 and 14 weeks of age IPV at 6 and14 weeks of age




Primary Outcome Measures :
  1. Change in antibody titers at 18 and 19 weeks of age compared to 6 weeks of age [ Time Frame: Change at 18 and 19 weeks of age compared to 6 weeks of age ]

    The primary analytical approach will be intention-to-treat analysis. Sum of seroconversion and priming as one outcome. Seroconversion is defined as either seronegative participants (<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32 from 6 weeks to 18 weeks of age, respectively.

    Priming is defined as absence of type 2 seroconversion by 18 weeks with type 2 seroconversion at 19 weeks, i.e. seronegative participants at 18 weeks (<1:8 titers) who become seropositive at 19 weeks (≥1:8) or a 4-fold rise in type 2 antibody titers at 19 weeks compared to 18 weeks




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Ages Eligible for Study:   6 Weeks to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants 6-7 weeks of age
  • Family that consents for participation in the full length of the study
  • Family that is able to understand and comply with planned study procedures

Exclusion Criteria:

  • Family that is unable to participate in the full length of the study
  • A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member
  • A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture
  • Acute diarrhea, infection or illness at the time of enrollment (6-7 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines
  • Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age)
  • Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall
  • Known allergy/sensitivity or reaction to polio vaccine or contents of polio vaccine
  • Infants from multiple births. Infants from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The infant(s) from a multiple birth who is/are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant
  • Infants from premature births (<37 weeks of gestation)

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): NCT02291263


Locations
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Bangladesh
Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)
Dhaka, Bangladesh
Sponsors and Collaborators
Centers for Disease Control and Prevention
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Md. Khalequzzaman, MBBS, PhD International Center for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: Abhijeet Anand, MBBS, MPH Centers for Disease Control and Prevention
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02291263    
Other Study ID Numbers: ICDDRB-RRC-PR-13097
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Centers for Disease Control and Prevention:
Polio
Inactivated polio vaccine
IPV
oral polio vaccine
Additional relevant MeSH terms:
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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