Skip to main content

Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial.

Publication ,  Journal Article
Schmader, KE; Liu, CK; Harrington, T; Rountree, W; Auerbach, H; Walter, EB; Barnett, ED; Schlaudecker, EP; Todd, CA; Poniewierski, M; Staat, MA ...
Published in: JAMA Netw Open
January 4, 2021

IMPORTANCE: Trivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3) are US-licensed for adults aged 65 years and older. Data are needed on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of these vaccines. OBJECTIVE: To compare safety, reactogenicity, and changes in HRQOL scores after aIIV3 vs HD-IIV3. DESIGN, SETTING, AND PARTICIPANTS: This randomized blinded clinical trial was a multicenter US study conducted during the 2017 to 2018 and 2018 to 2019 influenza seasons. Among 778 community-dwelling adults aged at least 65 years and assessed for eligibility, 13 were ineligible and 8 withdrew before randomization. Statistical analysis was performed from August 2019 to August 2020. INTERVENTIONS: Intramuscular administration of aIIV3 or HD-IIV3 after age-stratification (65-79 years; ≥80 years) and randomization. MAIN OUTCOMES AND MEASURES: Proportions of participants with moderate-to-severe injection-site pain and 14 other solicited reactions during days 1 to 8, using a noninferiority test (5% noninferiority margin), and serious adverse events (SAE) and adverse events of clinical interest (AECI), including new-onset immune-mediated conditions, during days 1 to 43. Changes in HRQOL scores before and after vaccination (days 1, 3) were also compared between study groups. RESULTS: A total of 757 adults were randomized, 378 to receive aIIV3 and 379 to receive HD-IIV3. Of these participants, there were 420 women (55%) and 589 White individuals (78%) with a median (range) age of 72 (65-97) years. The proportion reporting moderate-to-severe injection-site pain, limiting or preventing activity, after aIIV3 (12 participants [3.2%]) (primary outcome) was noninferior compared with HD-IIV3 (22 participants [5.8%]) (difference -2.7%; 95% CI, -5.8 to 0.4). Ten reactions met noninferiority criteria for aIIV3; 4 (moderate-to-severe injection-site tenderness, arthralgia, fatigue, malaise) did not. It was inconclusive whether these 4 reactions occurred in higher proportions of participants after aIIV3. No participant sought medical care for a vaccine reaction. No AECI was observed. Nine participants had at least SAE after aIIV3 (2.4%; 95% CI,1.1% to 4.5%); 3 had at least 1 SAE after HD-IIV3 (0.8%; 95% CI, 0.2% to 2.2%). No SAE was associated with vaccination. Changes in prevaccination and postvaccination HRQOL scores were not clinically meaningful and not different between the groups. CONCLUSIONS AND RELEVANCE: Overall safety and HRQOL findings were similar after aIIV3 and HD-IIV3, and consistent with prelicensure data. From a safety standpoint, this study's results support using either vaccine to prevent influenza in older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03183908.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JAMA Netw Open

DOI

EISSN

2574-3805

Publication Date

January 4, 2021

Volume

4

Issue

1

Start / End Page

e2031266

Location

United States

Related Subject Headings

  • Vaccines, Inactivated
  • Quality of Life
  • Male
  • Injections, Intramuscular
  • Influenza, Human
  • Influenza Vaccines
  • Humans
  • Female
  • Drug-Related Side Effects and Adverse Reactions
  • Aged, 80 and over
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Schmader, K. E., Liu, C. K., Harrington, T., Rountree, W., Auerbach, H., Walter, E. B., … Broder, K. R. (2021). Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open, 4(1), e2031266. https://doi.org/10.1001/jamanetworkopen.2020.31266
Schmader, Kenneth E., Christine K. Liu, Theresa Harrington, Wes Rountree, Heidi Auerbach, Emmanuel B. Walter, Elizabeth D. Barnett, et al. “Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial.JAMA Netw Open 4, no. 1 (January 4, 2021): e2031266. https://doi.org/10.1001/jamanetworkopen.2020.31266.
Schmader, Kenneth E., et al. “Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial.JAMA Netw Open, vol. 4, no. 1, Jan. 2021, p. e2031266. Pubmed, doi:10.1001/jamanetworkopen.2020.31266.
Schmader KE, Liu CK, Harrington T, Rountree W, Auerbach H, Walter EB, Barnett ED, Schlaudecker EP, Todd CA, Poniewierski M, Staat MA, Wodi P, Broder KR. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2031266.

Published In

JAMA Netw Open

DOI

EISSN

2574-3805

Publication Date

January 4, 2021

Volume

4

Issue

1

Start / End Page

e2031266

Location

United States

Related Subject Headings

  • Vaccines, Inactivated
  • Quality of Life
  • Male
  • Injections, Intramuscular
  • Influenza, Human
  • Influenza Vaccines
  • Humans
  • Female
  • Drug-Related Side Effects and Adverse Reactions
  • Aged, 80 and over