PMID- 35220869
OWN - NLM
STAT- MEDLINE
DCOM- 20220502
LR  - 20220601
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 21
IP  - 5
DP  - 2022 May
TI  - Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a 
      prospective, open-label, interventional, phase IV clinical study.
PG  - 685-692
LID - 10.1080/14760584.2022.2046469 [doi]
AB  - OBJECTIVE: This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib 
      pentavalent vaccine (Eupenta(TM)) based on the occurrence of adverse events (AEs) 
      following vaccination. METHODS: This was a prospective, open-label, single-arm, 
      interventional phase IV study. A single intramuscular injection of the study 
      vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, 
      and an end-of-study follow-up visit was scheduled at 18 weeks. RESULTS: In all, 
      3000 subjects were enrolled and received at least one dose of the study vaccine. 
      Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, 
      solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 
      (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited 
      AEs comprised pain/tenderness and upper respiratory tract infection, 
      respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) 
      subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs 
      each, considered related to the study vaccine. Six (0.2%) subjects died due to 
      unsolicited AEs, none of which were considered related to the study vaccine. No 
      AEs were reported at the end-of-study follow-up visit. CONCLUSIONS: The study 
      vaccine  had a safety profile similar to that reported in a previous clinical 
      study, and did not result in an increased risk of AEs known to be associated with 
      DTwP-based vaccines or previously unrecognized SAEs.
FAU - Capeding, Maria Rosario Z
AU  - Capeding MRZ
AD  - Department of Microbiology, Research Institute for Tropical Medicine, Muntinlupa 
      City, Philippines.
FAU - Gatchalian, Salvacion R
AU  - Gatchalian SR
AD  - Department of Pediatrics, Philippine General Hospital, Manila, Philippines.
FAU - Aseron, Mitzi
AU  - Aseron M
AD  - Department of Pediatrics, University of Perpetual Help Dalta Medical Center, Las 
      Pinas City, Philippines.
FAU - Lopez, Anna Lena L
AU  - Lopez ALL
AD  - Institute of Child Health and Human Development, University of the Philippines 
      Manila - National Institutes of Health, Philippines.
FAU - Yu, Delia C
AU  - Yu DC
AD  - De La Salle Medical and Health Sciences Institute, Cavite, Philippines.
FAU - Garcia Ibe, Maria E
AU  - Garcia Ibe ME
AD  - St. Luke's Medical Center, Quezon City, Philippines.
FAU - De Leon, Maria Nerissa
AU  - De Leon MN
AD  - Philippine Heart Center, Quezon City, Philippines.
FAU - Modequillo, Margaret
AU  - Modequillo M
AD  - Department of Pediatrics, Perpetual Succour Hospital, Cebu, Philippines.
FAU - Flavier, Mervin Edcel E
AU  - Flavier MEE
AD  - Department of Pediatrics, Southern Philippines Medical Center, Davao City, 
      Philippines.
FAU - Ong-Lim, Anna Lisa
AU  - Ong-Lim AL
AD  - Department of Pediatrics, Philippine General Hospital, University of the 
      Philippines Manila, Philippines.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220307
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Diphtheria-Tetanus-Pertussis Vaccine/adverse effects
MH  - *Haemophilus Vaccines
MH  - Haemophilus influenzae type b
MH  - *Hepatitis B Vaccines
MH  - Hepatitis B virus
MH  - Humans
MH  - *Immunization/adverse effects
MH  - Infant
MH  - Prospective Studies
MH  - *Vaccines, Combined/adverse effects
MH  - Vaccines, Conjugate
OTO - NOTNLM
OT  - DTwP-HBV/Hib vaccine
OT  - Philippines
OT  - pentavalent vaccine
OT  - safety
EDAT- 2022/03/01 06:00
MHDA- 2022/05/03 06:00
CRDT- 2022/02/28 05:27
PHST- 2022/03/01 06:00 [pubmed]
PHST- 2022/05/03 06:00 [medline]
PHST- 2022/02/28 05:27 [entrez]
AID - 10.1080/14760584.2022.2046469 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2022 May;21(5):685-692. doi: 10.1080/14760584.2022.2046469. 
      Epub 2022 Mar 7.