Age and Response to Flu Vaccines

NCT03328325 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 16-0101HHSN272201400005C
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.

Conditions

Influenza; Influenza Immunisation

Keywords

B Cell Response; Children; Evaluation; Healthy Adults; Influenza Vaccine

Outcome Measures

Primary Outcomes (6)

• Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)

  A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018

  Through Day 28

• Magnitude of the Serum Antibody Response by Microneutralization (MN)

  A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018

  Day 28

• Serum Antibody Response by Hemagglutination-inhibition (HAI)

  A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018

  Day 90

• Serum Antibody Response by Microneutralization (MN)

  A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018

  Day 90

• Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)

  A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018

  Day 28

• Specificity of the Serum Antibody Response by Microneutralization (MN)

  A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18

  Day 28

Secondary Outcomes (3)

• Age at Time of First Influenza A Exposure

  Baseline

• Baseline B Cell Reactivity

  Baseline

• Vaccine History (Number and Percentage of Participants to Receive Vaccine)

  Baseline

Study Arms (1)

Arm 1

EXPERIMENTAL

0.5 mL dose of quadrivalent (IIV-4) vaccine administered once intramuscularly, n=240

Biological: Influenza Virus Quadrivalent Inactivated Vaccine

Interventions

Influenza Virus Quadrivalent Inactivated Vaccine BIOLOGICAL

A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 \[H1N1\] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.

Arm 1

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged equal to or greater than 9 years of age and weigh at least 50 pounds
• The subject must be in good health, as determined by: medical history; and targeted physical examination, when necessary, based on medical history. Stable medical or psychiatric condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months
• The subject is able to understand and comply with the planned study procedures, including being available for all study visits
• The subject/parent has provided informed consent/assent prior to any study procedures
• Subjects who have not received seasonal flu vaccine for the current year

You may not qualify if:

• Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine
• Subject report of known latex allergy
• Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
• Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine
• The subject is a female of childbearing potential who is currently pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 90 days following receipt of vaccine. Pregnancy will be determined by subject interview. Pregnancy testing is not done in this study since there is no increased risk in pregnancy
• The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
• The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years
• Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-reference-html#estimated-comparative-daily-doses
• The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study
• The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days after vaccination
• The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include any acute or chronic medical disease or conditions defined as persisting for 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study
• Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved \> 3 days prior to enrollment
• The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period
• The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
• The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Rochester General Hospital - Infectious Disease Unit

Rochester, New York, 14621-3001, United States

Location

University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases

Rochester, New York, 14642-0001, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Angela Branche, MD, Site Principal Investigator
• Organization: University of Rochester

angela_branche@urmc.rochester.edu

585-275-5871

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 1, 2017
• Study Start: December 14, 2017
• Primary Completion: February 9, 2020
• Study Completion: April 20, 2020
• Last Updated: May 24, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-03-03

Locations

US (2)