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Previous Work - Vaccine Trials

INFLUENZA

DMID #08-0013: Phase I Randomized Study of the Safety, Dose Escalation, and Immunogenicity of Adjuvanted Influenza A/Anhui/05 Boosting in Subjects Previously Immunized with One or Two Doses of A/Vietnam/1203/04 or in Unprimed Individuals and Compared to Placebo.

DMID Protocol No: 09-0047: Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers (Greater Than or Equal to 6 – 36 months), Children (Greater than or Equal to 36 months – 9 years), and Adolescents (10 – 17 years).

FIM07 Phase IV Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults 65 Years of Age.

A multicenter, open-label, randomized to route of administration (intramuscular, subcutaneous, intradermal) study to investigate the safety and immunogenicity of the VAX102 influenza vaccine in healthy adults. Bill & Melinda Gates Foundation.

Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared with Standard Fluzone® in Adults and Elderly Subjects. Protocol FID29. Sanofi Pasteur.

A Single Center, Double Blind, Randomized, Escalating Dose-Ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults. Bill & Melinda Gates Foundation.

Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison with Intramuscular Vaccination with Standard Fluzone® in Ambulatory Elderly Subjects

MENINGOCOCCAL TYPE B

Chiron Protocol V2P3- A Phase 2 Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Chiron Meningococcal B Recombinant Vaccine +/- OMV When Administered at a 0-2-6 Month Schedule in Healthy Adolescents 11-18 Years. Novartis.

MENINGOCOCCAL TYPES A, C, W-135, AND Y

A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine when Administered with Routine Infant Vaccinations to Healthy Infants V59P23. Novartis.

V59P13E1 - An Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Menactra®. Novartis.

GSK 110870 (MenACWY-TT-057 PRI); 110871 (MenACWY-TT-057 BST): A Phase III, open, randomized, controlled, multicenter study to assess the safety and immunogenicity of GlaxoSmithKline's Biologicals' (GSK Biologicals) Neisseria meningitidis serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as compared to GSK Biologicals. Haemophilus influenzaetype b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) in healthy toddlers 12-15 months of age who were primed at 2, 4 and 6 months of age with Hib-MenCY-TT and Pediarix®, and to assess the safety and immunogenicity of MenACWY-TT co-administered with Infanrix® in healthy toddlers 15-18 months of age who were primed with HibMenCY-TT and Pediarix® at 2, 4, and 6 months of age as compared to the administration of Infanrix® alone in healthy toddlers 15-18 months of age who were primed withActHIB® and Pediarix® at 2, 4 and 6 months of age.

A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of Novartis Meningococcal ACWY Conjugate Vaccine when One Dose is Administered to Healthy Adolescents 11-18 Years of Age and to Compare the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine (Menactra™) when one Dose is Administered to Healthy Subjects 11-55 Years of Age, Protocol Number V59P13. Novartis.

A Phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of safety and immunogenicity of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined ((Hib-MenCY-TT) compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age. GlaxoSmithKline.

PNEUMOCOCCUS

A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 months - 17 Years in the United States. Wyeth Pharmaceuticals Inc.

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of 3 Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given with Routine Pediatric Vaccinations in the United States. Protocol 6096A1-3005. Wyeth Pharmaceuticals Inc.

BIODEFENSE

Evaluation of IMVAMUNE® Vaccinia Vaccine with Respect to Safety and Optimization of Immune Responses by Administration Timing, Dose Level Administered, and Subsequent Boost with Dryvax® Vaccinia Vaccine in Vaccinia-Naïve Adults. DMID protocol 06-0012.

COMBINATION VACCINES

Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 component Acellular Pertussis Vaccine in Infants and Toddlers. Sanofi Pasteur.

NEONATAL STUDIES

A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight (VLBW) Neonates for the Prevention of Staphylococcal Sepsis.

Fluconazole Prophylaxis for the prevention of Candidiasis in Infants <750 Grams Birth Weight.

The Impact of Development on Protein Utilization and Growth

ROTAVIRUS VACCINES

Safety and Efficacy of Pentavalent (GI, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants Protocol 006-03

HERPES VACCINES

A Study to Compare the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of Herpes Simplex Candidate Vaccine (gD2-AS04 )in Healthy HSV-1,-2 seronegative Female Pre-Adolescents and Adolescents, and to Determine Vaccine Immunogeniity in Same Healthy HSV 1-/2- females with Healthy HSV 1-/2- adult females.

A Phase III, double-blind, randomized study to compare the immunogenicity and safety of 3 commercial scale consistency lots of GlaxoSmithKlines Biologicals' herpes candidate vaccine in HSV -1/-2 females aged 10-17 years. GlaxoSmithKline.

HPV VACCINES

A Study to Demonstrate Immunogenicity and Tolerability of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Pre-Adolescents and Adolescents, and to Determine End-Expiry Specifications for the Vaccine.

Last updated October 2012