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Innovation


Study Identification Number


X04-VAR-402


Vaccine Trade Name


VARIVAX


Vaccine Generic Name


Varicella vaccine (live)


Study Title


A double-blind, randomised, controlled multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old children.


clinicaltrials.gov Number


NCT00432731


Clinical Study Report Synopsis


SPMSD Protocol X04-VAR-402


Study Identification Number


X04-MMRr-301


Vaccine Trade Name


M-M-R™II


Vaccine Generic Name


Measles, mumps, and rubella vaccine (live)


Study Title


An open, randomised, comparative, multicentre study of the immunogenicity and safety of M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® when administered concomitantly by intramuscular (IM) route or subcutaneous (SC) route at two separate injection sites in healthy subjects 12 to 18 months of age


clinicaltrials.gov Number


NCT00432523


Clinical Study Report Synopsis


SPMSD Protocol X04-MMRr-301

 


Study Identification Number


F05-MMRV-304


Vaccine Trade Name


PROQUAD


Vaccine Generic Name


Measles, mumps, rubella and varicella vaccine (live)


Study Title


An open, randomised, comparative, multicentre study of the immunogenicity and safety of ProQuad® when administered by intramuscular (IM) route or subcutaneous (SC) route to healthy children aged 12 to 18 months


clinicaltrials.gov Number


NCT00402831


Clinical Study Report Synopsis


SPMSD Protocol F05-MMRV-304

 


Study Identification Number


X06-MMRV-302


Vaccine Trade Name


PROQUAD


Vaccine Generic Name


Measles, mumps, rubella and varicella vaccine (live)


Study Title


An open, randomised, comparative, multicentre study of the immunogenicity and safety of concomitant versus separate administration of a combined measles, mumps, rubella and varicella live vaccine(ProQuad®) and a booster dose of Infanrix® hexa in healthy children 12 to 23 months of age


clinicaltrials.gov Number


NCT00432042


Clinical Study Report Synopsis


SPMSD Protocol X06-MMRV-302

 


Study Identification Number


MRV01C


Vaccine Trade Name


PROQUAD


Vaccine Generic Name


Measles, mumps, rubella and varicella vaccine (live)


Study Title


An open-label, multicentre study of the safety of a 2-dose regimen of a combined
measles, mumps, rubella and varicella live vaccine (ProQuad®) manufactured with recombinant human albumin (rHA) when administered to children in their second year of life


clinicaltrials.gov Number


NCT00560755


Clinical Study Report Synopsis


SPMSD Protocol MRV01C

 


Study Identification Number


MRV02C


Vaccine Trade Name


PROQUAD


Vaccine Generic Name


Measles, mumps, rubella and varicella vaccine (live)


Study Title


An open-label, 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


clinicaltrials.gov Number


NCT00566527


Clinical Study Report Synopsis


SPMSD Protocol MRV02C

 


Study Identification Number


S06-ROT-304


Vaccine Trade Name


ROTATEQ


Vaccine Generic Name


Rotavirus vaccine, live


Study Title


An open-label, 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


clinicaltrials.gov Number


NCT00443846


Clinical Study Report Synopsis


SPMSD Protocol S06-ROT-304

 


Study Identification Number


U05-PnPS-403


Vaccine Trade Name


PNEUMOVAX II


Vaccine Generic Name


Pneumococcal polysaccharide vaccine


Study Title


A double-blind comparative and randomised study in healthy adults of safety, tolerability,
and immunogenicity of PNEUMOVAX® II formulated with either all new process polysaccharides or all current process polysaccharides


clinicaltrials.gov Number


NA


Clinical Study Report Synopsis


SPMSD Protocol U05-PnPS-403

 


Study Identification Number


U01-A5I-302


Vaccine Trade Name


PEDIACEL


Vaccine Generic Name


Diphtheria, Tetanus, five component acellular Pertussis, inactivated Poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed)


Study Title


An open, randomised, controlled, phase III study of the immunogenicity and safety of a combined diphtheria, tetanus, five-component acellular pertussis, inactivated poliomyelitis and PRP-T Haemophilus influenzae type b conjugate vaccine (DT5aP-IPV-Hib) and diphtheria, tetanus and whole-cell pertussis vaccine reconstituting PRP-T Haemophilus influenzae type b conjugate vaccine (DTwP//Hib) and oral poliomyelitis vaccine (OPV), given concurrently with a licensed meningococcal group C conjugate vaccine to healthy UK infants at 2, 3 and 4 months of age AND Immunogenicity and safety of a diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine, adjuvanted (Td5aP-IPV) given to the children aged between 3.5 and 4.5 years of age


clinicaltrials.gov Number


NA


Clinical Study Report Synopsis


SPMSD Protocol U01-A5I-302 Part I
SPMSD Protocol U01-A5I-302 Part II
SPMSD Protocol U01-A5I-302 Part III

 


Study Identification Number


F05-TdI-301


Vaccine Trade Name


REVAXIS


Vaccine Generic Name


Diphtheria, Tetanus and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


Comparison of the immunogenicity and safety of a combined adsorbed low dose diphtheria, tetanus and inactivated poliomyelitis vaccine (REVAXIS®) with a combined diphtheria, tetanus and inactivated poliomyelitis vaccine (DT Polio®) when given as a booster dose at 6 years of age.


clinicaltrials.gov Number


NCT00447525


Clinical Study Report Synopsis


SPMSD Protocol F05-TdI-301

 


Study Identification Number


U01-Td5I-303


Vaccine Trade Name


REPEVAX


Vaccine Generic Name


Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


An open, randomised, controlled, phase III study of the immunogenicity and safety of combined adsorbed tetanus, low dose diphtheria, five component acellular pertussis and inactivated poliomyelitis vaccine (Td5aP-IPV), concomitant combined adsorbed tetanus, low dose diphtheria and five component acellular pertussis vaccine (Td5aP) and oral poliomyelitis vaccine (OPV) and combined adsorbed diphtheria, tetanus, two component acellular pertussis and inactivated poliomyelitis vaccine (DT2aP-IPV) given to healthy UK children a minimum of 3 years after priming with diphtheria, tetanus and whole cell pertussis (DTwP) vaccine at 2, 3 & 4 months of age


clinicaltrials.gov Number


NA


Clinical Study Report Synopsis


SPMSD U01-Td5I-303 Primary Series
SPMSD SPMSD U01-Td5I-303 Visit 3
SPMSD U01-Td5I-303 Visit 4
SPMSD U01-Td5I-303 Visit 5

 


Study Identification Number


F06-Td5I-301


Vaccine Trade Name


REPEVAX


Vaccine Generic Name


Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


A double-blind, controlled, randomised, clinical study to assess the safety of REPEVAX® administered one month after REVAXIS® or Placebo to healthy adults


clinicaltrials.gov Number


NCT00400309


Clinical Study Report Synopsis


SPMSD Protocol F06-Td5I-301

 


Study Identification Number


RPV02C


Vaccine Trade Name


REPEVAX


Vaccine Generic Name


Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults 18 years of age and older


clinicaltrials.gov Number


NCT00928785


Clinical Study Report Synopsis


SPMSD Protocol RPV02C

 


Study Identification Number


RPV03C


Vaccine Trade Name


REPEVAX


Vaccine Generic Name


Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


An open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis adsorbed vaccine (REPEVAX®) administered concomitantly versus non-concomitantly with an influenza vaccine (VAXIGRIP®) to subjects of 60 years of age and older


clinicaltrials.gov Number


NCT01249183


Clinical Study Report Synopsis


 SPMSD Protocol RPV03C

 


Study Identification Number


RPV04C


Vaccine Trade Name


REPEVAX


Vaccine Generic Name


Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)


Study Title


An open-label, multicentre study to evaluate the immunogenicity and safety of one dose of a diptheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®) in subjects of 40 years of age or older without a previous diphtheria-and-tetanus-containing booster within the last 20 years.


clinicaltrials.gov Number


NCT01287949


Clinical Study Report Synopsis


 SPMSD Protocol RPV04C

 


Study Identification Number


FID01C


Vaccine Trade Name


INTANZA 15 µg


Vaccine Generic Name


Influenza vaccine (split virion, inactivated)


Study Title


An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15µg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route (Addigrip® 15µg) in Subjects 65 Years of Age or Older.


clinicaltrials.gov Number


NCT00554333


Clinical Study Report Synopsis


SPMSD Protocol FID01C

 


Study Identification Number


HXV01C


Vaccine Trade Name


HBVAXPRO 5 µg


Vaccine Generic Name


Hepatitis B vaccine (rDNA)


Study Title


An open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5, and 11 to 13 months of age with either HEXAVAC® or INFANRIX®-HEXA


clinicaltrials.gov Number


NCT00693186


Clinical Study Report Synopsis


SPMSD Protocol HXV01C

 


Study Identification Number


rHB01C


Vaccine Trade Name


HBVAXPRO 10 µg


Vaccine Generic Name


Hepatitis B vaccine (rDNA)


Study Title


A study to estimate the immune response following a challenge dose in adults (?50 years old) vaccinated with a primary series of an hepatitis b vaccine


clinicaltrials.gov Number


NCT01251276


Clinical Study Report Synopsis


 SPMSD Protocol rHB01C


Study Identification Number


X06-Z-305


Vaccine Trade Name


ZOSTAVAX


Vaccine Generic Name


Shingles (herpes zoster) vaccine (live)


Study Title


An open-label, randomised, phase 3, 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


clinicaltrials.gov Number


NCT00561080


Clinical Study Report Synopsis


 SPMSD_Protocol_X06-Z-305

Study Identification Number

ZTV02C

Vaccine Trade Name

ZOSTAVAX

Vaccine Generic Name

Shingles (herpes zoster) vaccine (live)

Study Title

An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX® at minimum release specification approaching expiry potency in subjects >= 50 years old

clinicaltrials.gov Number

NCT00653266


Clinical Study Report Synopsis


 SPMSD_Protocol_ZTV02C

Study Identification Number

RVX01C

Vaccine Trade Name

TETRAVAC-ACELLULAIRE

Vaccine Generic Name

Diptheria (D), Tetanus (T), Pertussis (acellular, component) (aP) and Poliomyelitis (inactivated) (IPV) Vaccine (adsorbed)

Study Title

Antibody persistence in 11 to 13-year-old children previously vaccinated at 6 years old with either REVAXIS or DT polio, and immune response to a booster dose of TETRAVAC-ACELLULAIRE

clinicaltrials.gov Number

NCT01546909

Clinical Study Report Synopsis

 SPMSD_Protocol_RVX01C