PMID- 26553682
OWN - NLM
STAT- MEDLINE
DCOM- 20160830
LR  - 20220129
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 61 Suppl 5
IP  - Suppl 5
DP  - 2015 Nov 15
TI  - A Phase 3, Double-Blind, Randomized, Active Controlled Study to Evaluate the 
      Safety of MenAfriVac in Healthy Malians.
PG  - S507-13
LID - 10.1093/cid/civ626 [doi]
AB  - BACKGROUND: A safe, affordable, and highly immunogenic meningococcal A conjugate 
      vaccine (PsA-TT, MenAfriVac) was developed to control epidemic group A meningitis 
      in Africa. Documentation of the safety specifications of the PsA-TT vaccine was 
      warranted, with sufficient exposure to detect potential rare vaccine-related 
      adverse reactions. METHODS: This phase 3, double-blind, randomized, active 
      controlled clinical study was designed to evaluate the safety--primarily 
      vaccine-related serious adverse events (SAEs)--up to 3 months after 
      administration of a single dose of the PsA-TT vaccine to subjects aged 1-29 years 
      in Mali. Safety outcomes were also compared to those following a single dose of a 
      licensed meningococcal ACWY polysaccharide vaccine (PsACWY). RESULTS: No 
      vaccine-related SAEs occurred during the 3 months of follow-up of 4004 subjects 
      vaccinated with a single dose of PsA-TT. When compared to PsACWY (1996 subjects), 
      tenderness at the injection site appeared to be more frequent in the PsA-TT 
      group. However, rates of local induration, systemic reactions, adverse events 
      (AEs), and SAEs were similar in both groups, and unsolicited AEs and SAEs were 
      all unrelated to the study vaccines. CONCLUSIONS: The study confirmed on a large 
      scale the excellent safety profile of a single dose of PsA-TT when administered 
      to its entire target population of 1-29 years of age. CLINICAL TRIALS 
      REGISTRATION: PACTR ATMR201003000191317.
CI  - (c) The Author 2015. Published by Oxford University Press on behalf of the 
      Infectious Diseases Society of America.
FAU - Tapia, Milagritos D
AU  - Tapia MD
AD  - Department of Pediatrics, Center for Vaccine Development, University of Maryland 
      School of Medicine, Baltimore.
FAU - Sow, Samba O
AU  - Sow SO
AD  - Centre pour le Developpement des Vaccins, Ministere de la Sante, Bamako, Mali.
FAU - Haidara, Fadima Cheick
AU  - Haidara FC
AD  - Centre pour le Developpement des Vaccins, Ministere de la Sante, Bamako, Mali.
FAU - Diallo, Fatoumata
AU  - Diallo F
AD  - Centre pour le Developpement des Vaccins, Ministere de la Sante, Bamako, Mali.
FAU - Doumbia, Moussa
AU  - Doumbia M
AD  - Centre pour le Developpement des Vaccins, Ministere de la Sante, Bamako, Mali.
FAU - Enwere, Godwin C
AU  - Enwere GC
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
FAU - Paranjape, Gandhali
AU  - Paranjape G
AD  - DiagnoSearch Life Sciences, Mumbai, India.
FAU - Herve, Jacques
AU  - Herve J
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
FAU - Bouma, Enricke
AU  - Bouma E
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
FAU - Parulekar, Varsha
AU  - Parulekar V
AD  - DiagnoSearch Life Sciences, Mumbai, India.
FAU - Martellet, Lionel
AU  - Martellet L
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
FAU - Chaumont, Julie
AU  - Chaumont J
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
FAU - Plikaytis, Brian D
AU  - Plikaytis BD
AD  - Centers for Disease Control and Prevention, Atlanta, Georgia.
FAU - Tang, Yuxiao
AU  - Tang Y
AD  - Meningitis Vaccine Project, PATH, Seattle, Washington.
FAU - Kulkarni, Prasad S
AU  - Kulkarni PS
AD  - Serum Institute of India Ltd, Pune.
FAU - Hartmann, Katharina
AU  - Hartmann K
AD  - Department of Pharmacovigilance and Pharmacoepidemiology, Eidgenossische 
      Technische Hochschule, Zurich.
FAU - Preziosi, Marie-Pierre
AU  - Preziosi MP
AD  - Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine 
      Project, Department of Immunization, Vaccines and Biologicals, World Health 
      Organization, Geneva, Switzerland.
LA  - eng
GR  - 001/WHO_/World Health Organization/International
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (MenAfriVac)
RN  - 0 (Meningococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Mali/epidemiology
MH  - Meningitis, Meningococcal/epidemiology/microbiology/prevention & control
MH  - Meningococcal Vaccines/*administration & dosage/*adverse effects
MH  - Neisseria meningitidis, Serogroup A/immunology
MH  - Young Adult
PMC - PMC4639507
OTO - NOTNLM
OT  - Africa
OT  - MenAfriVac
OT  - active control
OT  - randomized clinical trial
OT  - vaccine safety
EDAT- 2015/11/11 06:00
MHDA- 2016/08/31 06:00
PMCR- 2015/11/09
CRDT- 2015/11/11 06:00
PHST- 2015/11/11 06:00 [entrez]
PHST- 2015/11/11 06:00 [pubmed]
PHST- 2016/08/31 06:00 [medline]
PHST- 2015/11/09 00:00 [pmc-release]
AID - civ626 [pii]
AID - 10.1093/cid/civ626 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2015 Nov 15;61 Suppl 5(Suppl 5):S507-13. doi: 
      10.1093/cid/civ626.