PMID- 31194712
OWN - NLM
STAT- MEDLINE
DCOM- 20200422
LR  - 20200422
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 38
IP  - 7
DP  - 2019 Jul
TI  - Safety, Tolerability and Immunogenicity of an MF59-adjuvanted, Cell 
      Culture-derived, A/H5N1, Subunit Influenza Virus Vaccine: Results From a 
      Dose-finding Clinical Trial in Healthy Pediatric Subjects.
PG  - 757-764
LID - 10.1097/INF.0000000000002345 [doi]
AB  - BACKGROUND: A/H5N1 influenza virus has significant pandemic potential, and 
      vaccination is the main prophylactic measure. This phase 2, randomized, 
      observer-blind, multicenter study evaluated the safety and immunogenicity of two 
      MF59-adjuvanted, cell culture-derived H5N1 (aH5N1c) vaccine formulations in 
      healthy pediatric subjects 6 months to 17 years old. METHODS: Subjects (N = 662) 
      received 2 aH5N1c doses 3 weeks apart, containing either 7.5 mug (full dose) or 
      3.75 mug (half dose) hemagglutinin antigen per dose. Local reactions and adverse 
      events (AEs) were assessed by age. Antibody responses were measured by 
      hemagglutination inhibition assay and assessed as geometric mean titers, 
      geometric mean ratios (GMRs) and percentages of subjects achieving titers >/=1:40 
      and seroconversion (NCT01776554). RESULTS: No vaccine-related serious AEs 
      occurred. Incidence of solicited local reactions and systemic AEs were similar 
      across vaccine groups. Tenderness and irritability in <6-year olds, and injection 
      site pain, myalgia and fatigue in 6-17-year olds were the most commonly reported 
      reactions in both full- and half-dose recipients. Frequencies of AEs were lower 
      after the second dose than the first dose in all vaccine and age groups. Three 
      weeks after the administration of a second dose, both full- and half-dose 
      formulations met the Center for Biologics Evaluation Research and Review (United 
      States) and Committee for Medicinal Products for Human Use (EU) licensure 
      criteria for titers >/=1:40 (full dose 96% subjects; half dose 86%), seroconversion 
      (full dose 96% subjects; half dose 86%), and GMR (full dose GMR 262; half dose 
      84). Antibody responses were highest in 6-35-month olds. CONCLUSIONS: In 
      pediatric subjects, both aH5N1c vaccine formulations were well tolerated and 
      highly immunogenic, meeting both US and EU licensure criteria for pandemic 
      influenza vaccines.
FAU - Chanthavanich, Pornthep
AU  - Chanthavanich P
AD  - From the Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol 
      University, Bangkok, Thailand.
FAU - Anderson, Edwin
AU  - Anderson E
AD  - Saint Louis University, St. Louis, Missouri.
FAU - Kerdpanich, Phirangkul
AU  - Kerdpanich P
AD  - Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao Hospital, 
      Bangkok, Thailand.
FAU - Bulitta, Michael
AU  - Bulitta M
AD  - Novartis Vaccines and Diagnostics, GmbH, Marburg, Germany (a GSK Company).
FAU - Kanesa-Thasan, Niranjan
AU  - Kanesa-Thasan N
AD  - GlaxoSmithKline LLC Rockville, Maryland, USA.
FAU - Hohenboken, Matthew
AU  - Hohenboken M
AD  - Seqirus, Inc., Cambridge, Massachusetts.
LA  - eng
SI  - ClinicalTrials.gov/NCT01776554
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 0 (Vaccines, Subunit)
RN  - 7QWM220FJH (Squalene)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage
MH  - Adolescent
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Healthy Volunteers
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Infant
MH  - Influenza A Virus, H5N1 Subtype/*immunology
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Polysorbates/*administration & dosage
MH  - Single-Blind Method
MH  - Squalene/*administration & dosage
MH  - United States
MH  - Vaccines, Subunit/administration & dosage/adverse effects/immunology
EDAT- 2019/06/14 06:00
MHDA- 2020/04/23 06:00
CRDT- 2019/06/14 06:00
PHST- 2019/06/14 06:00 [entrez]
PHST- 2019/06/14 06:00 [pubmed]
PHST- 2020/04/23 06:00 [medline]
AID - 00006454-201907000-00023 [pii]
AID - 10.1097/INF.0000000000002345 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2019 Jul;38(7):757-764. doi: 10.1097/INF.0000000000002345.