Previous Studies

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One of the first vaccine clinical trials occurred in May, 1796 when Edward Jenner, an English country doctor, vaccinated an 8 year old boy named James Phipps with fluid from a cowpox blister hoping to protect him from smallpox. It worked!


Vaccine studies completed more recently by the Clinical Trials Group

Last updated May 15, 2017

Click on the ClinicalTrials.gov Identifier (NCT number) for more information, including results in some cases.

NCT02037984 V114-004: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants Principal Investigator: Richard Rupp, MD

NCT02184572 115650 (MMR-162): A phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the safety and immunogenicity of GSK Biologicals' MMR vaccine (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 Prevnar 13 (US subset) in healthy children 12 to 15 months of age. Principal Investigator: Kwabena Sarpong, MD, MPH

NCT02213354 DMID 13-0034, H7N9 Mix and Match With MF59 in Healthy Elderly Persons: A Phase II Randomized, Partially-Blinded, Controlled Trial in Healthy Adults Aged 65 Years and Older to Assess the Safety, Reactogenicity, and Immunogenicity of an MF59-Adjuvanted, Monovalent Inactivated Influenza A/H7N9 Virus Vaccine Administered Intramuscularly at Different Intervals and Dosages Principal Investigator: Richard Rupp, MD

NCT02184572 115648 (MMR-160): 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 & Co., Inc.’s MMR vaccine (M-M-R II), as a first dose, both co-administered with Varivax, Havrix and Prevnar 13 (subset of children) to healthy children 12 to 15 months of age. Principal Investigator: Kwabena Sarpong, MD, MPH

NCT02242643 201234 (FLU Q-QIV-022): A Phase III, observer-blind, randomised, controlled, multi-centre study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine candidate, GSK2282512A (FLU Q-QIV), compared to Sanofi Pasteur’s quadrivalent influenza vaccine Fluzone® Quadrivalent, administered intramuscularly to children 6 to 35 months of age. Principal Investigator: Kwabena Sarpong, MD, MPH

NCT02062502 Merck V210-063: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX(TM) New Seed Process (NSP) Administered Concomitantly With M-M-R IIPrincipal Investigator: Richard Rupp, MD

NCT01938742 DMID 13-0032: A Phase II Randomized, Double-Blinded, Controlled Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of a Monovalent Influenza A/H7N9 Virus Vaccine Administered at Different Dosages Given With and Without MF59 Adjuvant - Principal Investigator: Richard Rupp, MD

NCT01266850 DMID 08-0017: Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq(R) and Rotarix(R): Principal Investigator: Kwabena Sarpong, MD

NCT01536405 V221-27 A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP) - Principal Investigator: Richard Rupp, MD

NCT01765426 INV-DEN-103: A Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults - Principal Investigator: Richard Rupp, MD NCT01651949 V503-003: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women - Principal Investigator: Richard Rupp, MD

NCT01542632 INV-DEN-104: A Randomized, Phase 1B Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers between the Ages of 18 - 45 Years - Principal Investigator: Richard Rupp, MD

NCT01461993 Protocol B1971011: A Phase 2, Randomized, Single-blind Trial, to Assess the Safety, Tolerability, and Immunogenicity of Gardasil® (HPV) Vaccine and a rLP2086 Vaccine When Administered Concomitantly in Healthy Subjects Aged 11 to <17 Years - Principal Investigator: Richard Rupp, MD

NCT01215188 V114-003: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™13 in Healthy Infants. - Principal Investigator: Richard Rupp, MD

NCT00856297 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® - Principal Investigator: Richard Rupp, MD

NCT00133497 DMID 04-039: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Safety and Efficacy of the Cytomegalovirus gB/MF59 Vaccine in Preventing Systemic Cytomegalovirus Infection in Healthy Adolescent Females - Principal Investigator: Richard Rupp, MD

NCT01513551 V114-002: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX™ 23) and Prevnar 13™ (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older. - Principal Investigator: Richard Rupp, MD

NCT00943202 DMID Protocol 09-0047: Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of a Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers (6 - <36 months), Children (36 months to 9 years), and Adolescents (10 to 17 years) - Principal Investigator: Christine Turley, MD

NCT00806195 V59P23: 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 - Principal Investigator: Richard Rupp, MD

NCT00976027 FIM07: Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults 65+ Years of Age - Principal Investigator: Alvah Cass, MD

NCT00761631 A Phase 3, Open Label Trial Evaluating the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States - Principal Investigator: Richard Rupp, MD

NCT00921947 A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular and 2.0 µg Subcutaneous Dosing With VAX102 (M2e-flagellin) in Healthy Adults - Principal Investigator: Christine Turley, MD

NCT00437021 DMID 06-0012: Evaluation of IMVAMUNE® Smallpox Vaccine With Respect to Safety and Optimization of Immune Responses by Different Vaccination Regimens in Vaccinia-Naive Adults - Principal Investigator: Christine Turley, MD

NCT00444457 Protocol 6096A1-3005: 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.- Principal Investigator: Richard Rupp, MD

NCT00551031 FID29: 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.- Principal Investigator: Richard Rupp, MD

NCT00603811 A Multicenter, Double-blind, Randomized, Escalating Dose-ranging Study to Investigate the Safety and Immunogenicity of the VAX102 Influenza Vaccine in Healthy Adults - Principal Investigator: Christine Turley, MD

NCT00450437 V59P13: 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 with that of Licensed Meningococcal ACWY Conjugate Vaccine (Menactra™) when One Dose is Administered to Healthy Subjects 11-55 Years of Age - Principal Investigator: Richard Rupp, MD

NCT00289783 103813 (Hib-MenCY-TT-009) [primary study]; 105067 (Hib-MenCY-TT-010) [booster study]: 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. - Principal Investigator: Christine Turley, MD

NCT00614614 110870 (MenACWY-TT-057 PRI); 110871 (MenACWY-TT-057 BST): Immunogenicity & Safety Study of a Booster Dose of an Investigational Vaccination Regimen Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers - Principal Investigator: Kwabena Sarpong, MD

NCT00388583 FID04: 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. - Principal Investigator: Christine Turley, MD

NCT00255047 M5A10: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5-component Acellular Pertussis Vaccine in Infants and Toddlers - Principal Investigator: Christine Turley, MD

NCT00297817 V72P3: A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Chiron Meningococcal B Recombinant Vaccine +/- OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age - Principal Investigator: Richard Rupp, MD

NCT00224484 208141/040: A double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ herpes simplex candidate vaccine (gD2 AS04) in healthy HSV seronegative and seropositive female subjects aged 10 –17 years.- Principal Investigator: Richard Rupp, MD

NCT00224471 208141/042: A Phase III, double-blind, randomized, study to compare: 1) the immunogenicity and safety of 3 commercial scale consistency lots of GlaxoSmithKline Biologicals’ herpes simplex candidate vaccine (gD2-AS04) in healthy HSV-1 and -2 seronegative (HSV 1-/2-) female subjects aged 10-17 years, and, 2) vaccine immunogenicity in healthy HSV 1-/2- females aged 10-17 years with healthy HSV 1-/2- adult females. - Principal Investigator: Richard Rupp, MD

NCT Identifier Not Available 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 Protocol No.: 016-01 - Principal Investigator: Richard Rupp, MD

NCT00090233 Safety and Efficacy of Pentavalent (G1, G2, G3, G4 and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants (Protocol No. 006-04) [Rotavirus Efficacy and Safety Trial (REST) (V260-006)] - Principal Investigator: Janak Patel, MD

 

Last updated May 15, 2017