Fever After Simultaneous Versus Sequential Vaccination in Young Children

NCT03165981 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Pro00082484200 2012 53663 0009
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fever After Vaccination; Fever; Febrile Seizure

Keywords

Influenza vaccine; fever following vaccination; PCV13 vaccine; DTaP vaccine; pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Fever Following Vaccination

  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.

  2 days post administration

Secondary Outcomes (11)

• Number of Participants With Fever Visit 1

  2 days post administration

• Number of Participants With Fever Visit 2

  2 days post administration

• Number of Participants With Grade 2 and/or 3 Fever Following Visit 1

  2 days post administration

• Number of Participants With Grade 2 and/or 3 Fever Following Visit 2

  2 days post administration

• Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2

  2 days post administration

Study Arms (2)

Simultaneous vaccination arm

OTHER

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; Biological: DTaP; Biological: IIV

Sequential vaccination arm

OTHER

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; Biological: DTaP; Biological: IIV

Interventions

PCV13 BIOLOGICAL

ACIP Recommended vaccine

Also known as: 13-valent Conjugate Pneumococcal Vaccine

Sequential vaccination arm; Simultaneous vaccination arm

DTaP BIOLOGICAL

ACIP Recommended vaccine

Also known as: Diphtheria, Tetanus, and Acellular Pertussis Vaccine

Sequential vaccination arm; Simultaneous vaccination arm

IIV BIOLOGICAL

ACIP Recommended vaccine

Also known as: Quadrivalent Inactivated Influenza Vaccine, IIV4, Flu Vaccine

Sequential vaccination arm; Simultaneous vaccination arm

Eligibility Criteria

• Age: 12 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Stable health as determined by investigator's clinical examination and assessment of child's medical history
• 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.
• 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
• The parent(s)/LAR(s) must be willing and capable of providing permission for their child to participate through the written informed consent process
• 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.
• The parent(s)/LAR(s) must be English speaking
• 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)

You may not qualify if:

• History of any seizure (including febrile seizure) in the child or a febrile seizure in a first degree relative
• Has already completed influenza vaccination during the current season per ACIP recommendations
• Receipt of more than 3 previous doses of DTaP
• Received the 3rd dose of DTaP within 6 months of Visit 1
• Receipt of more than 3 previous doses of PCV13
• Received the 3rd dose of PCV13 within 8 weeks of Visit 1
• 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.
• 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.
• History of Guillain-Barré syndrome within 6 weeks following a prior dose of influenza, DTaP, or tetanus toxoid containing vaccine
• History of a progressive neurologic disorder
• History of encephalopathy within 7 days of a previous pertussis-containing vaccine
• History of collapse within 3 days after a prior dose of DTaP
• Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Visit 1
• 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)
• A moderate to severe acute illness within 72 hours of Visit 1

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator
• Kaiser Permanente: collaborator

Study Sites (3)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Walter EB, Klein NP, Wodi AP, Rountree W, Todd CA, Wiesner A, Duffy J, Marquez PL, Broder KR. Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations. Pediatrics. 2020 Mar;145(3):e20191909. doi: 10.1542/peds.2019-1909. Epub 2020 Feb 6.

  PMID: 32029684 DERIVED

MeSH Terms

Conditions

Fever; Seizures, Febrile; Influenza, Human

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Seizures; Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit; Viral Vaccines

Results Point of Contact

• Title: Dr. Emmanuel B. Walter
• Organization: Duke University

chip.walter@duke.edu

919-620-5346

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: August 25, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: November 18, 2024
• Results First Posted: February 8, 2019

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)