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Trial record 24 of 281 for:    Panama

Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life (IPV005)

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ClinicalTrials.gov Identifier: NCT02111135
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : July 20, 2015
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Vaxtrials S.A.

Brief Summary:
Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life

Condition or disease Intervention/treatment Phase
Polio Biological: b-OPV Biological: m-OPV2 Biological: m-IPV HD Biological: t-IPV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

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Arm Intervention/treatment
Experimental: Group 1
b-OPV, m-IPV HD and m-OPV2
Biological: b-OPV
Biological: m-OPV2
Biological: m-IPV HD
Active Comparator: Group 2
b-OPV, t-IPV and m-OPV2
Biological: b-OPV
Biological: m-OPV2
Biological: t-IPV



Primary Outcome Measures :
  1. Safety [ Time Frame: 6 weeks ]
    To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (~ week 21 of life).

  2. Efficacy [ Time Frame: 4 weeks ]
    To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 (~14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and >4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (~ 18 weeks of age).



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

Inclusion Criteria:

  1. Age: 6 weeks (-7 to +14 days).
  2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
  3. Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.

Exclusion Criteria:

  1. Previous vaccination against poliovirus.
  2. Low birth weight (BW <2,500 gm).
  3. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
  4. Family history of congenital or hereditary immunodeficiency.
  5. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
  6. Known allergy to any component of the study vaccines.
  7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
  8. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
  10. Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
  11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

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): NCT02111135


Locations
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Panama
Hospital del Niño
Panama, Panama
Sponsors and Collaborators
Vaxtrials S.A.
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Xavier Sáez, MD Hospital Del Niño