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Fever After Simultaneous Versus Sequential Vaccination in Young Children

This study is currently recruiting participants.
Verified March 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03165981
First Posted: May 24, 2017
Last Update Posted: October 25, 2017
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.
Collaborators:
Centers for Disease Control and Prevention
Kaiser Permanente
Information provided by (Responsible Party):
Duke University
  Purpose
A prospective, randomized open-label clinical trial that will be conducted during the 2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be enrolled at Duke University Medical Center and Kaiser Permanente Northern California. Eligible children will be randomized to receive simultaneous or sequentially administered US licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit 1, and then return for a health education visit without vaccination about 2 weeks later (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2). Parents will record the occurrence of fever, solicited adverse events, medical care utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In addition, febrile seizures and serious adverse events will be recorded for the entire study period (from enrollment through 8 days following the Visit 2) as determined through parental report and chart review. Parental perceptions about their child's vaccine schedule will be assessed on the 8th day following Visit 2.

Condition Intervention Phase
Fever After Vaccination Fever Febrile Seizure Biological: PCV13 Biological: DTaP Biological: IIV Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open-label Clinical Trial to Assess Fever Following Simultaneous Versus Sequential Administration of PCV13, DTaP Vaccine and IIV in Young Children

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Occurrence of Fever following Vaccination [ Time Frame: 2 days post administration ]
    Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.


Secondary Outcome Measures:
  • Occurrence of Fever Visit 1 [ Time Frame: 2 days post administration ]
    Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1

  • Occurrence of Fever Visit 2 [ Time Frame: 2 days post administration ]
    Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2

  • Severity of Fever - Visit 1 Grade 2 and/or 3 [ Time Frame: 2 days post administration ]
    Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1.

  • Severity of Fever - Visit 2 Grade 2 and/or 3 [ Time Frame: 2 days post administration ]
    Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2.

  • Severity of Fever - Visit 1 and 2 Combined Grade 2 and/or 3 [ Time Frame: 2 days post administration ]
    Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined.

  • Duration of Fever - Visit 1 [ Time Frame: 8 days post administration ]
    Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1. Note: fever starting on day 1 or 2 could continue through day 8.

  • Duration of Fever - Visit 2 [ Time Frame: 8 days post administration ]
    Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 2. Note: fever starting on day 1 or 2 could continue through day 8.

  • Duration of Fever - Visit 1 and 2 Combined [ Time Frame: 8 days post administration ]
    Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1 and Visit 2 combined. Note: fever starting on day 1 or 2 could continue through day 8.

  • Medical Care Utilization - Visit 1 [ Time Frame: 2 days post administration ]
    Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1.

  • Medical Care Utilization - Visit 2 [ Time Frame: 2 days post administration ]
    Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 2.

  • Medical Care Utilization - Visit 1 and 2 Combined [ Time Frame: 2 days post administration ]
    Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1 and Visit 2 combined.


Estimated Enrollment: 280
Actual Study Start Date: August 25, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Simultaneous vaccination arm
In the study arm, subjects will receive PCV13, DTaP and IIV vaccines during visit 1. Approximately 2 weeks later, subjects will receive a health education visit without vaccination during study visit 2.
Biological: PCV13
ACIP Recommended vaccine
Other Name: 13-valent Conjugate Pneumococcal Vaccine
Biological: DTaP
ACIP Recommended vaccine
Other Name: Diphtheria, Tetanus, and Acellular Pertussis Vaccine
Biological: IIV
ACIP Recommended vaccine
Other Names:
  • Quadrivalent Inactivated Influenza Vaccine
  • IIV4
  • Flu Vaccine
Sequential vaccination arm
In the study arm, subjects will receive PCV13 and DTaP during study visit 1. Approximately 2 weeks later, subjects will receive the IIV vaccine during study visit 2.
Biological: PCV13
ACIP Recommended vaccine
Other Name: 13-valent Conjugate Pneumococcal Vaccine
Biological: DTaP
ACIP Recommended vaccine
Other Name: Diphtheria, Tetanus, and Acellular Pertussis Vaccine
Biological: IIV
ACIP Recommended vaccine
Other Names:
  • Quadrivalent Inactivated Influenza Vaccine
  • IIV4
  • Flu Vaccine

  Eligibility

Information from the National Library of Medicine

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:   12 Months to 16 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 12 through 16 months of age (i.e. from the 1-year birthday until the day before 17 months of age) at the time of vaccination
  2. Stable health as determined by investigator's clinical examination and assessment of child's medical history
  3. Has received all immunizations recommended by Advisory Committee for Immunization Practices (ACIP) during the first year of life with the exception of rotavirus and influenza vaccines.
  4. The parent(s)/ legally authorized representative(s) LAR(s) intend for the child to receive DTaP and PCV13 in addition to this season's IIV
  5. The parent(s)/LAR(s) must be willing and capable of providing permission for their child to participate through the written informed consent process
  6. The parent(s)/LAR(s) must be able to comply with the requirements of the protocol (e.g., completion of the memory aid (either electronic or paper diary), return for follow-up visits, respects intervals between the visits and have telephone access.
  7. The parent(s)/LAR(s) must be English speaking
  8. The parent(s)/LAR(s) must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed)

Exclusion Criteria:

  1. History of any seizure (including febrile seizure) in the child or a febrile seizure in a first degree relative
  2. Has already completed influenza vaccination during the current season per ACIP recommendations
  3. Receipt of more than 3 previous doses of DTaP
  4. Received the 3rd dose of DTaP within 6 months of Visit 1
  5. Receipt of more than 3 previous doses of PCV13
  6. Received the 3rd dose of PCV13 within 8 weeks of Visit 1
  7. History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any influenza, diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or pneumococcal vaccine.
  8. History of a severe allergic reaction (e.g., anaphylaxis) to any component (including egg protein) of any of the three vaccines used in this study; or a latex allergy.
  9. History of Guillain-Barré syndrome within 6 weeks following a prior dose of influenza, DTaP, or tetanus toxoid containing vaccine
  10. History of a progressive neurologic disorder
  11. History of encephalopathy within 7 days of a previous pertussis-containing vaccine
  12. History of collapse within 3 days after a prior dose of DTaP
  13. Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Visit 1
  14. Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to Visit 1, or expects to receive an experimental/investigational agent during the study period (up to 8 days after visit 2)
  15. A moderate to severe acute illness within 72 hours of Visit 1
  16. A reported temperature greater than or equal to 100.4°F (38.0°C) within 72 hours prior enrollment or a temperature (measured by temporal artery thermometer) greater than or equal to 100.4°F (38.0°C) at the time of enrollment
  17. Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 24 hours prior to enrollment
  18. Parent(s)/LAR is planning to administer a prophylactic antipyretic or medication on the day of, and/or within 7 days following Visit 1 or Visit 2
  19. Long term (at least 14 consecutive days) oral corticosteroids (prednisone 2 mg/kg/day or equivalent other glucocorticoid), any parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immune-modifying drugs or immunosuppressants within the preceding 6 months prior to Visit 1
  20. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and or their provider's routine physical examination
  21. Has an active neoplastic disease, a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
  22. Unable to receive an intramuscular injection in the thigh
  23. Any condition deemed by the investigator to place the child at increased risk as a result of their participation in the study
  24. Any child or grandchild of a study investigator or study team member
  Contacts and Locations
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): NCT03165981


Contacts
Contact: Emmanuel B Walter, MD, MPH 919-620-5346 chip.walter@duke.edu
Contact: Christopher A Todd, MPH 919-681-7791 chris.todd@duke.edu

Locations
United States, California
Kaiser Permanente Northern California Not yet recruiting
Oakland, California, United States, 94612
Contact: Nicola Klein, MD, PhD    510-267-7540    nicola.klein@kp.org   
Contact: Kristin Goddard, MPH    510-267-7502    kristin.x.goddard@kp.org   
Principal Investigator: Nicola Klein, MD, PhD         
United States, Georgia
Centers for Disease Control and Prevention Not yet recruiting
Atlanta, Georgia, United States, 30333
Contact: Karen Broder, MD       krb2@cdc.gov   
Contact: Patricia Wodi, MD       lgz1@cdc.gov   
Principal Investigator: Karen Broder, MD         
Sub-Investigator: Patricia Wodi, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Emmanuel B Walter, MD    919-620-5374    chip.walter@duke.edu   
Contact: Christopher A Todd, MPH    919-681-7791    chris.todd@duke.edu   
Principal Investigator: Emmanuel B Walter, MD         
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Kaiser Permanente
Investigators
Principal Investigator: Emmanuel B Walter, MD, MPH Duke University
Principal Investigator: Karen Broder, MD Centers for Disease Control and Prevention
Principal Investigator: Nicola Klein, MD, PhD Kaiser Permanente
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03165981     History of Changes
Other Study ID Numbers: Pro00082484
200 2012 53663 0009 ( Other Grant/Funding Number: CDC )
First Submitted: May 23, 2017
First Posted: May 24, 2017
Last Update Posted: October 25, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Duke University:
Influenza vaccine
fever following vaccination
PCV13 vaccine
DTaP vaccine
pneumococcal vaccine

Additional relevant MeSH terms:
Seizures
Fever
Seizures, Febrile
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Body Temperature Changes
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs