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university of tampere: timo vesikari: studies:
Vaccine Research CenterTampereen yliopisto Vaccine Research Center

Current studies

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
Medimmune 8897
EudraCT: 2016-001677-33

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
Medicago CP-PRO-QVLP-012
EudraCT: 2017-001239-38

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
Seqirus V130_12
EudraCT: 2016-001677-33

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.
Start: 2017
Pfizer B1971057

EudraCt: 2016-004421-17

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
EudraCT: 2016-004763-40

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.
Start: November2016
GSK RSV F-004

EudraCT: 2016-002733-30

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

Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine in toddlers 12 to 23 months of age.
Start: november 2016
Sanofi Pasteur MET-51
EudraCT: 2016-000749-30

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
EudraCT: 2014-001120-30

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.
Star: 2014
GSK DTPA (BOOSTRIX)-047
EudraCT: 2014-001119-38

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
GSK V102_15E1
EudraCT: 2016-002230-69

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
GSK: ROTA_081
EudraCT: 2016-000598-19

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
Pfizer B1971035
EudraCT:  2011-004400-38

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
EudraCT: 2016-000274-37

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
EudraCT: 2015-00965-30

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 rLP2086.
Start: September 2012
Pfizer B1971033
EudraCT: 2011-005697-313

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
Regeneron R2222-RSV-1332
EudraCT: 2015-001714-96

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
Takeda: NOR-202
EudraCT: 2014-000778-20

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)
EudraCT: 2012-005816-25

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)

EudraCT: 2013-001549-15

 

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
Novartis: V118_05E1
EudraCT: 2014-002599-95


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
Novartis: V118_05

EudraCT: 2012-000218-12

 

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
EudraCT: 2013-000775-32

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

EudraCT: 2011-005374-33

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
Merck V260-035

EudraCT: 2012-001611-23

 

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
EurdaCT: 2011-004891-12

 

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

EurdaCT: 2010-021491-28

 

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
Marck V114-003

EudraCT:

 

Phase 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

EudraCT:2010-023393-39

 

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
MSD 503-002

EudraCT: 2010-023393-39

 

The 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.
Start: 4.10.2010
GSK FLU D-PAN H1N1-AS03-044 (114452)

EudraCT:

 

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
GSK 113090-006

EudraCT: 2008-000367-42

 

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
GSK 113077-022

EudraCT: 2009-015791-94

 

Phase 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)

EudraCT: 2008-006551-51

 

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

EudraCT:

 

Phase 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
Baxter 810706

EudraCT: 2009-013105-34

 

A 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
MedImmune MI-CP178
EudraCT: 2008-002651-24

 
Vaccine Research Center
FM 3/Biokatu 10, 33014 University of Tampere
tel. +358 3 355 111
Maintained by: rokotetutkimuskeskus@uta.fi
Last update: 12.9.2017 11.08 Muokkaa