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

Vaccine researches from 1997

Here were present our completed studies.

A phase III, randomized, double-blind and active-controlled study in children and adolescents aged 3-17 years to assess the safety and immunogenicity of Abbot’s candidate quadrivalent influenza vaccine and it's non-inferiority versus trivalent influenza vaccine.
Start: August 2016
Abbot INFQ3002

EudraCT: 2015-005482-23

A phase III, randomized, observer blind, multicenter study to evaluate the safety and immunogenicity of repeated exposure to either the same or
alternate type of vaccine, adjuvanted or non-adjuvanted quadrivalent subunit influenza virus vaccine (aQIV or QIV), administered to subjects previously
vaccinated in trial V118_05.
Start: January 2016
Novartis V118_05E3

A Phase II, randomized, controlled, observer-blinded study to describe the immunogenicity, safety and tolerability of neisseria meningitidis serogroup B bivalent recombinant lipoprotein 2086 vaccine (bivalent rLP 2086) in healthy subjects aged ≥24 months to < years.
Start: August 2015
Pfizer B1971017
EudraCT:  2014-000933-21

A Phase II, randomized, open-label, active-controlled study to describe the safety and immunogenicity of MenACYW conjugate vaccine compared to NIMENRIX® in toddlers 12 to 23 months of age.
Start: March 2015
Sanofi Pasteur: MET-54 (Men ACYW Conjugate Vaccine)
EudraCT: 2014-004367-20

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to Novartis Meningococcal group B vaccine, in Healthy Adolescents.
Start: August 2014
Novartis: V102_15

EudaCT: 2014-02212457

 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 2014
Novartis: V118_05

EudraCT: 2012-000218-12

A phase IIIA randomized, observer-blind, controlled, multinationally study to evaluate the safety and immunogenicity of GSK Biologials' MMR vacine (209762 Priorix®) compared to Merck & Co., Inc.'s MMR vaccine (M-M-R II® or VaxPro®), as a first dose, both co-administered with Varivax®, Havrix® (all subjects) and Prevenar 13® (US subset) in healthy children 12 to 15 months of age.
Start: February 2015
GSK: MMR-162 (115650)
EudraCT: 2011-006161-18

 

Phase III, randomized, blind-observer, active-controlled, multi-center trial to study immunogenicity and safety of a hexavalent DTaP-IPV-Hep B-PRP-T combined vaccine or Infanrix hexaTMconcomitantly administered with 13-valent pneumococcal conjugate vaccine (PCV13) at 3, 5, 11 to 12 months of age in healthy infants in Europe.
Start: October 2012
Sanofi Pasteur A3L38

EudraCT: 2012-001054-26

 

A Phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix®) at an end of shelf-life potency compared to Merck's MMR-II vaccine (M-M-R®II). Both are co-administered with Varivax® and Havrix®, and given on a two-dose schedule to healthy children in their second year of life.
Start: November 2012
GSK Biological MMR-161
EurdaCT: 2011-004905-26

 

Phase II, randomized, placebo-controlled single-blind trial to assess the safety, tolerability and immunogenicity of Repevax® and rLP2086 vaccines when administered concomitantly in healthy subjects aged 11-19 years.
Start: May 2011
Pfizer B1971010

EudraCT: 2010-022449-38

 

Phase II randomized, placebo-controlled, single-blind trial to assess the safety, tolerability and immunogenicity of rLP2086  vaccine when administered in either 2- or 3-dose regimens in healthy aged 11-19 years.
Start: April  2011
Pfizer B1971012

EudraCT: 2009-014493-18

 

Phase III randomized, double-blind, active comparator controlled clinical trial to study the safety, tolerability and immunogenicity of V419 in healthy infants when administered at age 2, 3, 4 and 12 months.
Start: May  2011
Merck:V419-007 02

EudraCT: 2010-021490-37

 

A phase II, double-blind, multicent re study to evaluate the safety and immunogenicity of a booster dose of new formulations of GSK combinined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study (DTPa-HBV-IPV-124 PRI).
Start: 14.10.2011
GSK 114843 DTPa-HBV-IPV-125 BST:124

EudraCT:2011-000876-33

 

A phase III, open-label, multi-center, extension study of V72P13E1 to assess antibody persistence at one year after a fourth dose boost or two catch-up doses of Novartis meningococcal B recombinant vaccine administered starting at 12 months of age and to evaluate the response to a third dose boost or two catch-up doses starting at 24 months of age.
Study clinics: Espoo, Helsinki South, Helsinki East, Vantaa East, Vantaa West, Järvenpää, Kuopio, Lahti, Oulu, Pori, Tampere, Turku, Kotka, Seinäjoki, Kokkola
Starting date in June 2010
Novartis Vaccines V72P13E2
EudraCT: 2009-018101-52

 

A phase III open-label clinical trial to study the immunogenicity and tolerability of V503, a multivalent human papillomavirus (HPV) L1 virus-like particle (VLP) vaccine, given concomitantly with Repevax in preadolescents and adolescents (11 to 15 year olds).
Study clinics: Lahti, Vantaa West, Helsinki East, Järvenpää, Kotka, Pori, Kuopio
Starting date in May 2010
Merck V503-007
EudraCT: 2009-016218-26

 

Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children.
2009-2010
SanofiPasteur, GPA 12

 

A phase III, open label, multi-center, extension study to evaluate the safety, tolerability and immunogenicity of Novartis meningococcal B recombinant vaccine when administered as a booster at 12 months of age or as a two-dose catch-up to healthy toddlers who participated in study V72P13.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio, Kokkola
Starting date in April 2009
Novartis Vaccines V72P13E1
EudraCT: 2008-006301-17

 

A multicenter, double-blind study of the safety, tolerability, and immunogenicity of pnemococcal conjugate vaccine (V114) compared to Prevnar in healthy adults and toddlers.
Study clinics: Vantaa West, Helsinki East, Järvenpää
Starting date in December 2009
Merck V114-001
EudraCT: 2009-015103-58

 

A phase I/II study to assess the safety and immunogenicity of a vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.
Study clinics: Tampere, Espoo, Helsinki South, Vantaa East, Oulu, Turku, Seinäjoki, Kokkola
Starting date in November 2009
Baxter 810706
EudraCT: 2009-013105-34

 

Immunogenicity and safety of multiple formulations of an intramuscular inactivated, split virion swine-origin A/H1N1 influenza vaccine with and without adjuvant in healthy European subjects aged 6 to 35 months.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio, Kokkola
Starting date in September 2009
Sanofi Pasteur GPF09
EudraCT: 2009-013858-32

 

Immunogenicity and safety of multiple formulations of an intramuscular inactivated, split virion swine-origin A/H1N1 influenza vaccine with and without adjuvant in healthy European subjects aged 3 to 17 years.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio, Kokkola
Starting date in August 2009
Sanofi Pasteur GPF08
EudraCT: 2009-013346-83

 

An open-label phase I/II study to assess the immunogenicity and safety of a single prime-boost vaccination schedule with a Vero cell-derived whole virus H5N1 influenza vaccine in healthy volunteers aged 18 to 59 years.
Study clinics: Espoo, Helsinki South
Starting date in February 2009
Baxter 810802
EudraCT: 2008-005133-30

 

A phase III double-blind, cluster-randomized, controlled study to evaluate the impact on nasopharyngeal carriage, 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.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio, Kokkola
Starting date in February 2009
GlaxoSmithKline Biologicals 112595 (10PN-PD-DIT-053)
EudraCT: 2008-006551-51

 

A Phase Ib, Randomized, Observer-blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two injections of Trivalent Inactivated Influenza Vaccine with or without One of three Different Doses of Adjuvant in Healthy Children, Aged <36 Months.
2008-2009
Novartis, V104P2

 

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with MF59 (FLUAD-H5N1), in Adult and Elderly Subjects.
2008-2009
Novartis V87P13

 

An open-label phase III study to assess the safety and immunogenicity of a Vero cell-derived whole virus H5N1 influenza vaccine in an adult and elderly population as well as in specified risk groups.
Study clinics: Espoo, Helsinki South, Vantaa East, Tampere, Turku
Starting date in October 2008
Baxter 810705
EudraCT: 2008-000558-11

 

A phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD® versus control vaccines in healthy subjects aged 6 to <72 months.
Study clinics: Tampere, Turku, Pori, Lahti, Oulu, Järvenpää, Vantaa East, Vantaa West, Helsinki East, Helsinki South, Espoo, Kotka, Kuopio, Kokkola, Seinäjoki
Starting date in October 2008
Novartis Vaccines V70P5
EudraCT: 2007-003786-41

 

A phase III, partially blinded, randomized, multi-center, controlled study to evaluate immunogenicity, safety and lot to lot consistency of Novartis meningococcal B recombinant vaccine when administered with routine infant vaccinations to healthy infants.
Study clinics: Tampere, Turku, Oulu, Kuopio, Pori, Lahti, Kotka, Seinäjoki, Kokkola, Helsinki East, Helsinki South, Espoo, Vantaa West, Vantaa East, Järvenpää
Starting date in June 2008
Novartis Vaccines V72P13
EudraCT: 2007-007781-38

 

A phase I randomized placebo-controlled, double-blind study to evaluate safety and immunogenicity of AERAS-404 when administered as a single IC31 adjuvant amount with different AERAS-404 (HyVac4) antigen amounts in HIV-negative BCG-vaccinated adults without evidence of tuberculosis infection.
Study clinic: Tampere
Starting date in May 2008
Aeras C-006-404
EudraCT: 2007-006333-14

 

Immunogenicity and reactogenicity of GSK Bio's DTPa-HBV-IPV/Hib vaccine when given as a booster dose. Phase II.
Study clinics: Vantaa East, Järvenpää, Turku, Pori, Tampere, Oulu
Starting date in February 2008
GlaxoSmithKline Biologicals 111344
EudraCT: 2007-005343-16

 

An open-label, Phase III, randomised, comparative, multi-centre study of the immunogenicity and safety of a 1-dose regimen and different 2-dose regimens of a Zoster vaccine (Live), ZOSTAVAX®, in subjects ≥ 70 years of age.
Study clinics: Tampere, Vantaa East, Vantaa West, Helsinki East, Järvenpää, Kotka
Starting date in January 2008
Sanofi Pasteur X06-Z-305
EudraCT: 2007-000744-28

 

A Phase III, open, randomized, controlled primary vaccination study to demonstrate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate (MenACWY-TT) vaccine and its non-inferiority compared to Meningitec™ and to demonstrate the non-inferiority of the co-administartion of MenACWY-TT with Priorix-Tetra™ compared to the administration of each of the two vaccines given separately, in healthy 12 through 23-month-old children.
2007-2008
GSK, MenACWY-TT-039


A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals´ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec or Mencevax ACWY to healthy subjects aged 1 through 10 years of age.
GlaxoSmithKline Biologicals 108658 (MenACWY-TT-027)
EudraCT: 2006-004236-70 

 

A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals' meningococcal serogroup A, C, W-135, Y - tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec administered in healthy 12 through 23 month-old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio
Starting date in August 2009
GlaxoSmithKline Biologicals 112036 (MenACWY-TT-048)
EudraCT: 2008-003824-51

 

A phase II, observer-blind, parallel groups, single center, extension study to evaluate the immunogenicity and safety following a single intramuscular dose of FLUAD® or Vaxigrip® influenza vaccines in healthy children who received either one or other vaccine in previous V70P2 study.
Study clinics: Tampere, Turku, Pori, Lahti, Espoo, Vantaa, Järvenpää, Oulu
Starting date in November 2007
Novartis V70P2E1
EudraCT: 2007-003339-22

 

A combined phase II/III, observer-blind, randomized, multi-center study to evaluate safety, tolerability and immunogenicity of trivalent subunit influenza vaccines, produced either in mammalian cell culture or in embryonated hen eggs (Fluvirin®), in healthy children and adolescents aged 3 to 17 years.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka
Starting date in November 2007
Novartis Vaccines V58P12
EudraCT: 2007-001534-13

 

An open-label, phase IIIb, randomised, comparative, multi-centre study of the immunogenicity and safety of a 2-dose regimen of ProQuad® manufactured with rHA administered to healthy children from 9 months of age.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka, Seinäjoki, Kuopio, Kokkola
Starting date in November 2007
Sanofi Pasteur MSD MRV02C
EudraCT: 2007-002468-88

 

A phase III clinical trial to evaluate the efficacy, immunogenicity, safety and tolerability of Zostavax in subjects 50 to 59 years of age. Protocol V211-022.
Study clinics: Helsinki South, Helsinki East, Vantaa East, Vantaa West, Espoo, Järvenpää, Lahti, Turku, Pori, Tampere, Kotka, Seinäjoki, Kokkola, Kuopio, Oulu
Starting date in November 2007
Merck V211, Protocol 022
EudraCT: 2007-004020-20

 

A phase III, randomized, observer-blind, placebo-controlled, multicenter study to assess clinical efficacy of a cell-derived subunit influenza vaccine and an egg-derived subunit influenza vaccine in the 2007-2008 influenza season in healthy adult subjects.
Study clinics: Espoo, Helsinki South, Helsinki East, Vantaa East, Vantaa West, Järvenpää, Kokkola, Kotka, Kuopio, Lahti, Oulu, Pori, Seinäjoki, Tampere, Turku
Starting date in October 2007
Novartis Vaccines V58P13
EudraCT: 2007-002871-15

 

A phase II, randomized, controlled, observer-blind, single-center study to evaluate the immunogenicity, safety and tolerability of two doses of FLUAD-H5N1 influenza vaccine in subjects aged 6 months to 17 years.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Järvenpää, Kotka
Starting date in September 2007
Novartis Vaccines V87P6
EudraCT: 2007-002480-27

 

Randomized, phase I, observer-blind, placebo-controlled study to assess the immunogenicity and safety of two adjuvant formulations of an egg-derived pandemic surface antigen influenza vaccine in healthy adults aged ≥ 18 years and ≥ 49 years.
Study clinics: Turku, Helsinki South, Helsinki East, Espoo, Vantaa East, Vantaa West.
Starting date in September 2007
Solvay Pharmaceuticals S205.1.001
EudraCT: 2007-000876-17

 

A phase III open, randomized, controlled primary vaccination study to demonstrate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' meningococcal serogroup ACWY conjugate (MenACWY-TT) vaccine and its non-inferiority compared to Meningitec and demonstrate the non-inferiority of the coadministration of MenACWY-TT with Priorix-Tetra compared to the administration of each of the two vaccines given separately, in healthy 12 through 23-month-old children.
Study clinics: Tampere, Turku, Pori, Espoo, Lahti, Vantaa East, Vantaa West, Oulu, Helsinki South, Helsinki East, Seinäjoki, Järvenpää, Kotka, Kuopio
Starting date in May 2007
GlaxoSmithKline Biologicals 109670
EudraCT: 2006-006580-23

 

A study in healthy infants of the safety, tolerability, and immunogenicity of haemophilus influenzae, type b / hepatitis B vaccine manufactured with a modified process. Phase III.
Study clinics: Tampere, Turku, Pori, Lahti, Oulu, Järvenpää, Vantaa East, Vantaa West, Helsinki South, Espoo
Starting date in February 2007
Merck V121, Protocol 019-00
EudraCT: 2006-003648-46

 

An open-label, phase IIIb, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C conjugate (MCC) vaccine in healthy infants.
Study clinics: Tampere, Pori, Turku, Järvenpää, Vantaa East, Vantaa West, Oulu, Espoo, Helsinki South
Starting date in January 2007
Sanofi Pasteur MSD S06-ROT-304
EudraCT: 2006-0054-4511

 

A Phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
GSK / Smerud, Protocol 023
December 2003 - November 2004, 2067 children
Vaccine Research Clinics: Tampere, Espoo/Tapiola, Espoon Keskus, Espoonlahti, Lahti, Pori, Turku, Jyväskylä, Vantaa West, Vantaa East, Helsinki North, Helsinki South, Helsinki East, Oulu, Kokkola, Pori, Rauma, Vaasa, Seinäjoki, Kuopio, Kotka, Järvenpää, Riihimäki, Hyvinkää, Porvoo, Lappeenranta, Kouvola
Doctors: Aino Karvonen, Tiina Korhonen, Maaria Viitasalo, Heli Siljander, Heli Yli-Jyrä, Tiina Karppa, Pauli Riikonen, Kaija Westergård, Niklas Lindblad, Krista Mykrä, Dmitrij Kruglikov, Pauli Ylitalo, Leila Mikkilä, Jussi Ojanperä, Vesa Vähäsarja , Arja Sokka, Tuomas Tocklin, Annika Lönnberg, Helena Lauren

 

A Phase II, Randomized, Observer-Blind, Active Controlled, Multi-center, Dose Ranging Study to Evaluate the Immunogenicity and Safety of Different Formulations of Chiron Conjugate Meningococcal ACWY Vaccine and Chiron Conjugate Meningococcal C Vaccine (Menjugate R) administered to Healthy Toddlers Aged 12 - 16 Months.
A phase II study, Chiron Vaccines / Remedium, Protocol V59P2
June 2003 - January 2005, 537 children
Vaccine Research Clinics: Tampere, Pori, Turku, Espoo, Jyväskylä, Lahti, Vantaa, Kuopio, Oulu
Doctors: Aino Karvonen, Tiina Korhonen, Pauli Riikonen, Jonna Maunu, Niklas Lindblad, Mirjami Aaltonen, Heli Siljander, Sirkka Parry, Tiina Karppa, Anneli Pere, Arja Sokka (Hynninen), Leila Mikkilä

 

Study of the Efficacy, Safety, and Immunogenicity of RotaTeq at Expiry Potency
A phase III study, Merck & Co., Inc, Protocol 007
November 2002 - 2003, 493 children
Vaccine Research Clinics: Tampere, Pori, Turku
Doctors: Aino Karvonen, Tiina Korhonen, Pauli Riikonen, Jonna Maunu

 

A Prospective, Randomized, Double-blind, Placebo-Controlled Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A&B, Live, Cold-Adapted, Liquid Formulation (CAIV-T), Administered Concomitantly with a Combination Live, Attenuated, Mumps, Measles and Rubella Vaccine in Healthy Children 11-24 Months.
A phase I study,
Wyeth Lederle Vaccines, Protocol D153-P522
September 2002 - May 2003, 200 children
Vaccine Research Clinics: Tampere, Lahti, Pori, Turku, Jyväskylä
Doctors: Aino Karvonen, Tiina Korhonen, Tiina Karppa, Pauli Riikonen, Jonna Maunu, Sirkka Parry

 

A Prospective, Randomized, Open-label, Controlled Trial to compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) with Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children with Asthma aged 6 to 17 years.

 

A phase I study, Wyeth Lederle Vaccines, Protocol D153-P515
September 2001 - May 2002, 22 children
Vaccine Research Clinics: Tampere (TAYS)
Doctors: Anssi Luoma, Marita Paassilta

 

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Infants.
A phase I study, Wyeth Lederle Vaccines / MedFiles, Protocol D153-P518
September 2001 - November 2002 (120 children)
Study sites: Tampere, Espoo, Lahti, Pori, Turku, Jyväskylä

 

A phase II, open, controlled clinical study to assess the immunogenicity, reactogenicity and safety of a 2nd dose of SmithKlineBeecham Biologicals' measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age.

 

A phase II study, GSK, Protocol MeMuRu-OKA-017
2001 (92 children)
SmithKlineBeecham Biologicals
Study site: Tampere

 

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live cold-Adapted (CAIV-T) in Healthy Children Attending Day Care Centers.
A phase III study, Wyeth Lederle Vaccines / MedFiles, Protocol D153-P502
October 2000 - November 2001 (481 children)
Second year: 2001-2002
Study sites: Tampere, Espoo, Lahti, Pori, Jyväskylä

 

Safety and Efficacy of Pentavalent (G1, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants.
A phase III study, Merck & Co., Inc, Protocol 006
Nov 2000 - Nov 2004 (Last recruitment date 15 August 2003) 23 444 infants
Study sites: Tampere, Nokia, Valkeakoski, Espoo/Tapiola, Espoon Keskus, Espoonlahti, Kirkkonummi, Lohja, Lahti, Pori, Turku, Jyväskylä, Oulu, Kokkola, Vaasa, Pori, Seinäjoki, Rauma, Kuopio, Varkaus, Mikkeli, Lappeenranta, Kouvola, Kotka, Järvenpää, Riihimäki, Hyvinkää, Nurmijärvi, Vantaa West, Vantaa East, Helsinki North, Helsinki South, Helsinki East, Porvoo
Doctors: Merimaaria Espo, Aino Karvonen, Tiina Korhonen, Ulla-Kaisa Mickos, Anssi Luoma, Mirjami Aaltonen, Arja Heikkinen, Anne Sarajuuri, Kirsi Isoherranen, Heli Siljander, Tiina Karppa, Jukka Majuri, Pauli Riikonen, Leila Pajula, Marketta Juntunen, Eila Heikkilä, Teija Heikkinen, Kaija Westergård, Janne Vehanen, Marika Grönroos, Jonna Maunu, Krista Mykrä, Niklas Lindblad, Samuli Ylitalo, Leila Mikkilä, Vesa Vähäsarja, Christer Häggqvist, Jussi Ojanperä, Anne Kotaniemi-Syrjänen, Arja Sokka, Tuomas Toklin, Annika Löndberg, Helena Laurent, Anna-Liisa Kotsalainen, Pirjo Laitinen, Leena Kujala, Heta Khary, Johanna Khan, Anneli Pere, Sirpa Sairanen, Saeed Khan, Karl Lönnberg, Jonas Bondestam, Olle Nyblom, Panu-Pekka Pohjola, Maari Cederberg, Heta Haaslahti, Mirkka Lumia, Elina Koskikallio, Johanna Anttila-Bosdestam, Ashraf Benyamin

 

A phase IIb, double-blind, randomized, placebo-controlled study to assess the efficacy, immunogenicity, reactogenicity and safety of two doses of SB Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
A phase IIb study, Protokol GSK (SmithKlineBeecham Biologicals) Rota 004
1.10.2000-15.9.2002 (405 infants)
Study sites: Tampere, Espoo, Lahti, Pori, Turku, Jyväskylä

 

A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of SB Biologicals' live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus
A phase II study, GSK ( SmithKlineBeecham Biologicals), Protocol Rota 003
1.4.2000-4.12.2000 (192 infants)
Study sites: Tampere, Espoo

 

A Randomized, Double-Blind Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine, Trivalent, Types A & B, Live cold-Adapted (CAIV-T) in Children Who Attend Day Care.
A phase III study, Wyeth Lederle / MedFiles, Protocol D153-P500
October 1999 - November 2000, Tampere 146, Turku 60 (206 children)
Study sites: Tampere, Turku

 

Protocol 005-001 Safety, Immunogenicity, and Efficacy in Healthy Infants of G1, G2, G3, G4, and P1 Human-Bovine Rotavirus Reassortant Vaccine.
A phase IIb study, Merck, Protocol rota 005
January 1998 - September 2000 (1300 + 646 children)
Study sites: Tampere, Espoo, Lahti, Pori

 

A phase II, double-blind trial of the safety and immunogenicity and efficacy of tetravalent bovine rotavirus vaccine (BV-TV) and tetravalent rhesus rotavirus vaccine (RV-TV).
A phase II study, Wyeth-Lederle Vaccines and Pediatrics, Protocol D127-P801
May 1997 - August 1998 (510 children)
Study sites: Tampere ja Lahti

 

RRV-TV (Rhesus-human reassortant tetravalent) rotavirus vaccine for newborns. Placebo controlled.
A phase I study, Wyeth-Lederle Vaccines and Pediatrics, Protocol D127-P500
June 1997 - August 1998 (94 children)
Study sites: TAYS (children and maternity wards)

 
Vaccine Research Center
FM 3/Biokatu 10, 33014 University of Tampere
tel. +358 3 355 111
Maintained by: rokotetutkimuskeskus@uta.fi
Last update: 28.6.2017 14.10 Muokkaa