Below we present our open studies for which the follow-up visits are still ongoing. Certain studies are not conducted every Finnish Vaccine Research Clinic. The studies for which we are currently recruiting participants will be found here.
A Phase 2b randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of MEDI8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in healthy preterm infants.
Start: september 2017
A randomized, observer-blind, placebo-controlled, multicenter, phase 3 study to assess the efficacy, safety, and immunogenicity of a plant-derived quadrivalent VLP
influenza vaccine in adults 18-64 years of age.
Start: August 2017
A phase III/IV, stratified, randomized, observer blind, multicenter clinical study to evaluate the efficacy, safety and immunogenicity of a cell-based quadrivalent subunit influenza virus vaccine compared to non-influenza comparator vaccine in subjects ≥ 2 years to <18 years of age.
Start: August 2017
A Phase III, randomized, active-controlled, observer-blinded study to assess the immunogenicity, safety and tolerability of bivalent rLP2086 when administered as a 2-dose regimen and the first-in-human study to describe the immunogenicity, safety and tolerability of a bivalent rLP2086 containing pentavalent vaccine (MenABCWY) in healthy subjects ≥
10 to <26 years of age.
Phase IV, randomized, blind observer, controlled, multi-center, study to assess immunogenicity and safety of quadrivalent influenza vaccine (VaxigripTetra®) in Pregnant Women.
Start: april 2017
Sanofi Pasteur GQM14
A phase I/II, randomized, observer-blind, controlled
multi-country study to assess the safety, reactogenicity and
immunogenicity of a single intramuscular dose of GSK Biologicals’
investigational RSV vaccine (GSK3003891A) in healthy pregnant women aged 18 to
40 years and infants born to vaccinated mothers.
GSK RSV F-004
An open-label phase III clinical trial to study the immunogenicity and tolerability of GARDASIL®9 (A Multivalent Human
Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in adult women (27-
to 45-year-olds) compared to young adult women (16 to 26 year olds).
Start: July 2016
Merck Sharp & Dohme Corp./MSD Finland Oy, HPV V503-004
EudraCT NUMBER: 2015-005093-38
A phase II, double-blind, randomized, multicenter trial to evaluate the safety, tolerability,
and immunogenicity of V114 compared to Prevenar 13™ in healthy infants.
Start: march 2017
Merck Sharp & Dohme Corp./MSD Finland Oy, PNEUMOKOKKI V114_008
EudraCT NUMBER: 2016-001117-25
and safety of an investigational quadrivalent meningococcal conjugate vaccine
in toddlers 12 to 23 months of age.
Start: november 2016
Sanofi Pasteur MET-51
Evaluation of Immunogenicity and Safety of a
Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers
Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery.
GSK DTPA (Boostrix)-048
A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix™ in pregnant women.
GSK DTPA (BOOSTRIX)-047
A phase 2b,
open-label, multi-center study assessing the Immunological persistence of
antibodies at approximately 2 years after the last meningococcal vaccination in
study V102_15 and the response to a booster dose of GSK Men ABCWY or
meningococcal serogroup B vaccines, in healthy adolescents.
Start: November 2016
A phase IIIA, randomized, partially-blind, multi-center study to
evaluate the clinical consistency of three production lots of the Porcine
circovirus (PCV)-free liquid formulation of GlaxoSmithKline (GSK) Biologicals’
oral live attenuated human rotavirus (HRV) vaccine and to evaluate the
PCV-free liquid formulation of GSK Biologicals’ HRV vaccine as compared to the
currently licensed lyophilized formulation of the HRV vaccine in terms of
immunogenicity, reactogenicity and safety when administered as a two-dose
vaccination in healthy infants starting at age 6-12 weeks.
Start: November 2016
A Phase 2, randomized, controlled, observer-blinded study, conducted to describe the immunogenicity, safety and tolerability of A Neisseria Meningitidis serogroup B bivalent recombinant lipoprotein
2086 Vaccine (Bivalent Rlp2086) when administered to healthy toddlers aged 12 to <18 months or 18 to <24 months.
Start: August 2015
Long-term persistance of hepatitis B and pertussis antibody responses in healthy 4-to
5-year old children previously vaccinated with a 2-dose or 3-dose primary
series and booster schedule with Vaxelis or Infanrix hexa.
Sanofi Pasteur PRI03C
A Phase IIIB, non-randomized, open-label, multi-country, multi-centric cross-vaccination
study to evaluate the safety of GSK Biologicals’ Herpes Zoster subunit (HZ/su)
vaccine (GSK 1437173A) when administered
intramuscularly on a two-dose schedule to subjects who previously received
placebo in ZOSTER-006 or ZOSTER-022 studies.
Start: November 2015
GSK Zoster 056
A phase 3 study to assess the persistence of hSBA response
up to 48 motnhs after completion of a primary series of bivalent rLP2086, and
the safety, toleralibility, and immunogenicity of a booster dose of bivalent
Start: September 2012
A phase III, randomized, double-blind, placebo-controlled
study evaluating the efficacy and safety of a
human monoclonal antibody, REGN2222, for the prevention of medically attended RSV infection in preterm infants.
Start: August 2015
A Phase II, Randomized,
Double-Blind, Dosage and Adjuvant Justification, safety and Immunogenicity
Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
combined with Aluminum Hydroxide, with and without Monophosphoryl Lipid A
Adjuvant on Children, Todlers, and Infants.
Start: June 2015
A phase III,
open, multi-centre, controlled study to evaluate the long-term antibody
persistence at 2, 3, 4, 5 and 6 years after a booster dose of GlaxoSmithKline
(GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid
conjugate vaccine (MenACWY-TT) versus one dose of Meningitec™ administered in
healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5
(112036), who were primed with the same vaccine in the study MENACWY-TT-039
(109670) at 12-24 months of age.
Start: April 2015
GSK: Men-ACWY-TT-102 EXT: 048 Y2, 3, 4, 5, 6)
A Phase IIIb open. multi-center study to evaluate the long-term antibody persistence at 6, 7, 8, 9, and 10 years afetr the administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal conjugate vaccine MenACWY-TT versus one dose of Meningetec™ vaccine or one dose of GSK's menongococcal polysaccharide vaccine Mencevax ACWY, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered 10 uears after primary vaccination of 1-10 years old subjects with MenACWY-TT, Meningetec or Mencevax ACWY.
Start: April 2015
GSK: Men ACWY-TT-100 EXT: 027 Y6, 7, 8, 9, 10)
A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05.
Star: October 2014
A prospective, epidemiological, interventional, multi-country based, cohort study to assess the disease burden of respiratory syncytial virus (RSV) associated lower respiratory tract infections (LRTIs) in newborns, from birth up to 2 years of age.
Start: December 2013
GSK: 200150 (EPI-RSV-005 BOD)
A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.Start: October 2013
Efficacy, Immunogenicity, and Safety Study of Clostridium difficile
Toxoid Vaccine in Subjects at Risk for C. difficile Infection. To assess the efficacy of the C. difficile vaccine in
preventing the onset of symptomatic primary C. difficile infection (CDI)
confirmed by polymerase chain reaction (PCR) in adult subjects aged ≥
50 years who are at risk for CDI and have received at least 1 injection.
Start: October 2013
Sanofi Pasteur: H-030-014
Phase III, randomized, double-blind, active-controlled, multi-center trial to assess safety and immunogenicity of the quadrivalent influenza vaccine administered via the intramuscular route in 1225 child subjects aged 3 to 8 years.
Start: September 2013
Sanofi Pasteur: GQM02
A double-blind, randomized, controlled multicenter study to evaluate the safety, tolerability and immunogenicity of a new formulation of RotaTeqTM rotavirusvaccine given in healthy infants aged 6-12 weeks.
Start: June 2013
A Phase IIIA, randomized, observer-blind, controlled, multinational consistency study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck's MMR vaccine (M-M-R®II), as a first dose, both co-administered with Varivax® and Havrix® to healthy children 12 to 15 months of age.
Start: November 2012
GSK Biological MMR-160
A phase III randomized, double-blind, active-comparator controlled
clinical trial to study the safety, tolerability, and immunogenicity of PR51
hexavalent vaccine in healthy infants when given at 2, 4 and 11 to 12 months
Start: 1 Mar 2012
Merck Sharp&Dohme corp, V419-008
A multicenter, double-blind study of the safety,
tolerability, and immunogenicity of pneumococcal conjugate vaccine (V114) compared
to PrevnarTM 13 in healthy infants. Prot. V114-003.
Start: November 2010
III randomized, double-blind study evaluating the immunogenicity and tolerability
of the new 9-valent HPV papillomavirus vaccine (V503) compared to the Gardasil®
vaccine already on the market for children and young people aged 9-15 years.
Start: Feb 2011
Sanofi Pasteur MSD GDS01C, V503-009
Phase III double-blind, multi-centre study evaluating the efficacy,
tolerability and manufacturing consistency of a new 9-valent HPV papillomavirus
vaccine (V503) in preadolescents and adolescents (aged 9-15 years) with
comparison to young women (aged 16-26 years).
Start: Nov 2009
study evaluates the immunogenicity and safety of the 2010/2011 seasonal
influenza vaccine (FluarixTM) in young people aged 10 to 17, who have
already received one dose of GSK PandemrixTM vaccine. There are two study groups and subjects are
allocated by computer to one of these.
Subjects receive either one dose of seasonal influenza vaccine or two
doses of control vaccine, which is GSK hepatitis A vaccine HavrixTM.
GSK FLU D-PAN H1N1-AS03-044 (114452)
A phase III ramdomized, observer-blind, placebo-control multi-centre
study to assess the efficacy, safety and immunogenicity of Herpes zoster
vaccine (GSK1437173A), when administered intramuscularly on a 0, 2 -month
schedule on adults aged 50-69 years.
Start: September 2010
A phase III randomized, observer-blinded, placebo-control multi-centre trial
to assess the profylactic efficacy, safety and immunogenicity of Herpes zoster
vaccine (GSK1437173A) on adults aged over 70 years, when administered on a 0, 2
-month schedule in adults aged 70 years and older.
Start: September 2010
III doubleblind cluster-randomized controlled study evaluating the impact on
nasopharyngeal carriagem immunogenicity and safety of GSK Biologicals’
10-valent pneumococcal and non-typeable Haemophilus influenzae protein D
conjugate vaccine in children starting vaccination below 18 months of age.
Start: February 2009
GlaxoSmith Kline Biologicals 112595 (10PN-PD-DID-053)
ROTAVIRUS DIARRHOEA FOLLOW-UP STUDY AFTER INITIATION OF GENERAL
ROTAVIRUS (ROTATEQ) VACCINATION ON FINNISH CHILD HEALTH CLINICS
An epidemiological study for children under the age of 16 years hospitalized for gastroenteritis. The purpose is to ascertain whether use of rotavirus vaccine reduces children’s contracting rotavirus and if the hospitalizations due to this diminish. Rotavirus vaccine was included in the finnish national vaccination programme in September 2009.
Start: December 2009
Sanofi Pasteur MSD RTQ01E
I/II study to assess the safety and immunogenicity of ver cell-derived whole
virus influenza vaccine in healthy infants, children and adolescents aged 6
months to 17 years.
Start: Dec 2009 – Aug 2012
phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation
study to evaluate the safety, tolerability, immunogenicity and vaccine-like
viral shedding of MEDI-534, a live, attenuated intranasal vaccine against
respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3), in
healthy 6 to < 24 month-old children and in 2 month-old infants.
Study clinics: Tampere, Lahti, Kokkola, Helsinki South, Helsinki East, Järvenpää, Kuopio, Oulu, Pori, Turku
Starting date in April 2009