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A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio 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: NCT03016949
Recruitment Status : Withdrawn (Regulatory timelines for approval expired)
First Posted : January 11, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

Brief Summary:
The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV Biological: f-IPV Phase 3

Detailed Description:

The study will be conducted in a setting where only IPV is being used for polio prevention in infant immunization schedules.

The study population will include infants from Uruguay, a pioneer country in immunization programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012, after which the program changed to an all-IPV schedule without transition.

The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6 months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.

Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36 weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate vaccine, Rotavirus and will be administered concomitantly.

Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule will be recommended for the post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
Biological: IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Experimental: Group B
3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
Biological: f-IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Experimental: Group C
2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
Biological: IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Experimental: Group D
2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
Biological: f-IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Experimental: Group E
3 doses IPV IM at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
Biological: IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Experimental: Group F
3 doses f-IPV ID at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
Biological: f-IPV
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)




Primary Outcome Measures :
  1. Seroconversion [ Time Frame: To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV. ]
    Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.


Secondary Outcome Measures :
  1. Seroconversion [ Time Frame: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV. ]
  2. Median titers [ Time Frame: To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV. ]
  3. SAEs (Serious Adverse Events) [ Time Frame: To be assessed throughout the complete study period, approx. 18 months. ]
  4. IMEs (Important Medical Events) [ Time Frame: To be assessed throughout the complete study period, approx. 18 months. ]
    These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.

  5. Severe local reactions [ Time Frame: To be assessed throughout the complete study period, approx. 18 months. ]
    Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Weeks to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination
  • Healthy, as assessed from medical history and physical examination by a study physician
  • Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures

Exclusion Criteria:

  • Vaccinated with any poliovirus vaccine prior to inclusion
  • A household contact with OPV vaccination history in the past 4 weeks
  • HIV infection or pharmacologic immunosuppression.
  • Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)
  • Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections.
  • Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination.
  • Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.

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): NCT03016949


Sponsors and Collaborators
Fidec Corporation
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Stella Gutierrez, MD CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay
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Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT03016949    
Other Study ID Numbers: IPV-003-ABMG
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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