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Trial record 6 of 272 for:    american indian

Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04978818
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Condition or disease Intervention/treatment Phase
Haemophilus Influenzae Type B Infection Drug: Vaxelis Drug: PedvaxHIB Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization of participants will be done at the site level. Participants will be assigned randomly 1:1, to the Vaxelis arm or the PedvaxHIB arm. This is an unblinded study. Study staff will log into a secure system to randomize the participant. The study vaccine associated with that randomization will be selected. A verifier will confirm that the correct vaccine was selected. After verification, study staff will administer the dose.
Masking: None (Open Label)
Masking Description: This is an unblinded, post-licensure study; study staff will not be blinded to participant intervention status.
Primary Purpose: Prevention
Official Title: Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children
Actual Study Start Date : January 27, 2022
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines
Drug Information available for: PedvaxHIB

Arm Intervention/treatment
Active Comparator: Vaxelis
165 infants will be randomized to the Vaxelis group, which is licensed for primary vaccination at 2, 4 and 6 months of age.
Drug: Vaxelis
Eligible infants will be block randomized to one of two study arms.
Other Name: Intervention

Active Comparator: PedvaxHIB arm
165 infants will be randomized to the PedvaxHIB group, which is licensed for primary vaccination at 2 and 4 months of age.
Drug: PedvaxHIB
Eligible infants will be block randomized to one of two study arms.
Other Name: Comparator




Primary Outcome Measures :
  1. anti-PRP IgG Geometric Mean Concentration (GMC) [ Time Frame: 30 days after dose 1 ]
    The non-inferiority of the anti-PRP IgG Geometric Mean Concentration (GMC) 30 days after dose 1 of Vaxelis administered at 2 months of age, compared to PedvaxHIB.


Secondary Outcome Measures :
  1. Proportion of anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 [ Time Frame: 30 days after dose 1 of Vaxelis or PedvaxHIB ]
    Describe the proportion of infants with anti-PRP IgG ≥0.15 µg/mL 30 days after dose 1 of Vaxelis or PedvaxHIB.

  2. Proportion of anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 121 [ Time Frame: 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB ]
    Describe the proportion of infants with anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 121 after initiation of the primary series, i.e., 60 days after dose 2 of Vaxelis and dose 2 of PedvaxHIB.

  3. Proportion of anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 151 [ Time Frame: 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB ]
    Describe the proportion of infants with anti-PRP IgG ≥0.15 µg/mL and ≥1.0 µg/mL on Day 151 after initiation of the primary series, i.e., 30 days after dose 3 of Vaxelis and 90 days after dose 2 of PedvaxHIB.



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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born at gestational age of ≥35 weeks
  • AI/AN infant between 6 to 12 weeks of age (42-90 days) at the time of the first vaccination (i.e., Study Day 1)
  • Written informed consent provided by parent(s)/Legally Authorized Representative(s) (LARs)
  • Investigators believe that the parent(s)/LARs can and will comply with the requirements of the protocol (i.e., return for follow-up visits, recall of adverse events)
  • Infant is available to complete the follow-up period of 5 months
  • Healthy infant, as established by medical history and clinical examination before entering the study

Exclusion Criteria:

  • History of receipt of blood, blood products, or immunoglobulin products since birth or expected receipt through the duration of the study
  • Chronic seizure or evolving or unstable neurologic disorder
  • Congenital Heart Disease, except for uncomplicated CHD (e.g., PDA, small septal defect)
  • Infant of mother with HIV infection
  • History of reaction or hypersensitivity likely to be exacerbated by any vaccine component, or to latex
  • Infant with confirmed or suspected immunocompromising medical condition, based on medical history, including chronic administration (more than 14 days in the lifetime) of immunosuppressants or other immune-modifying drugs since birth
  • Administration of infant vaccines other than birth dose Hepatitis B, prior to the time of enrollment
  • Any condition which might interfere with the evaluation of the investigational product, or interpretation of subject safety or study results, in the opinion of the investigator
  • Child of an employee of the sponsor, clinical study site, or any other individual involved with the conduct of the study, or an immediate family member of such individuals
  • Acute illness and/or fever (temperature ≥100.4 F or ≥38.0 C) at time of enrollment (Note: Participant with fever may be enrolled at later date if symptoms have resolved and all other criteria for inclusion are met at that time)
  • Current (or within the past 7 days) or expected receipt of immunosuppressive agents, including steroids, except topical or inhaled steroids (Note: For oral corticosteroids, this will mean prednisone (≥ 0.5 mg/kg/day, or equivalent; participant may be enrolled at a later date if medication use ends and all other criteria for inclusion are met at that time)

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): NCT04978818


Contacts
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Contact: Hanna Foster, MSGH 765-730-0119 hfoster3@jhu.edu

Locations
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United States, Arizona
Chinle Center for American Indian Health Recruiting
Chinle, Arizona, United States, 86503
Contact: Mary Thomas    928-674-5051      
Fort Defiance Center for American Indian Health Recruiting
Fort Defiance, Arizona, United States, 86504
Contact: Estar Denny    928-729-2435      
Whiteriver Center for American Indian Health Not yet recruiting
Whiteriver, Arizona, United States, 85491
Contact: Tally Jones    928-338-5215      
United States, New Mexico
Gallup Center for American Indian Health Recruiting
Gallup, New Mexico, United States, 87301
Contact: Carol Tso    505-722-6865      
Shiprock Center for American Indian Health Recruiting
Shiprock, New Mexico, United States, 87420
Contact: Megan Gardner    505-368-4030      
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Laura Hammitt, MD Johns Hopkins Bloomberg School of Public Health
Publications:
State of Alaska Epidemiology Bulletin; Aug 11, 2009

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04978818    
Other Study ID Numbers: IRB00011170
First Posted: July 27, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Native American
Vaccine
Additional relevant MeSH terms:
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Influenza, Human
Haemophilus Infections
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses