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