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A double-blinded, controlled study of the efficacy, immuongenicity, safety and tolerability and effectiveness of a pneumococcal conjugate vaccine containing seven serotypes (6B, 14, 19F, 23F, 18C, 4 and 9V) compared to a control meningococcal C vaccine in Navajo and Apache Indian infants

Project Number: 97-02-04-01-2

Project Status: Completed

Year Trial Started: 1997

Year Trial Ended: 2000

Study Type(s): Phase III Clinical Trial

Principal Investigator: O'Brien, Katherine

Pathogen(s): Streptococcus pneumoniae

IND(s): Wyeth Research, Viral Vaccines (NY, United States)

Product Category: Polysaccharide vaccine

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A Phase 3 Study of MEDI-524 (Motavizumab), an enhanced potency humanized respiratory syncytial virus (RSV) monoclonal antibody for the prevention of RSV disease among Native American infants in the southwestern United States

Project Number: H22040804A1

Project Status: Ongoing

Year Trial Started: 2004

Year Trial Ended: Ongoing

Study Type(s): Phase III Clinical Trial

Principal Investigator: O'Brien, Katherine

Pathogen(s): Respiratory Syncytial Virus

IND(s): MedImmune (Gaithersburg, United States)

Product Category: Monoclonal Antibody

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A phase IV open randomized controlled comparative multi-cente US study of the safety of GlaxoSmithKline Biologicals' combination hepatitis A and B vaccine (Twinrix) administered on a 0, 1, 6 month schedule by intra-muscular injection compared concurrently administered monovalent vaccine (Havrix) on a 0, 6 month schedule and Energix-B on a 0, 1 6 month schedule in healthy adults 18 years of age and older

Project Number: H22010719A1

Project Status: Completed

Year Trial Started: 2002

Year Trial Ended: 2003

Study Type(s): Phase IV Clinical Trial; Post-licensure Safety

Principal Investigator: O'Brien, Katherine

Pathogen(s): Hepatitis A; Hepatitis B

Product Category: Combination Vaccine, Killed/ Inactivated vaccine, Recombinant Protein

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Effect of a 23-valent pneumococcal polysaccharide vaccine on Native American adult pneumococcal disease

Project Number: 99-06-11-05-1

Project Status: Completed

Year Trial Started: 2000

Year Trial Ended: 2002

Study Type(s): Post-licensure Study/Evaluation

Principal Investigator: O'Brien, Katherine

Pathogen(s): Streptococcus pneumoniae

Product Category: Polysaccharide vaccine

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Effect of maternal influenza vaccination on respiratory disease among infants

Project Number: H22020611A2

Project Status: Completed

Year Trial Started: 2002

Year Trial Ended: 2005

Study Type(s): Post-licensure Study/Evaluation

Principal Investigator: O'Brien, Katherine

Pathogen(s): Influenza

Product Category: Killed/ Inactivated vaccine

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Long term impact of the pneumococcal conjugate vaccine on pneumococcal nasopharyngeal colonization and immune correlates for disease protection

Project Number: H22050705B2

Project Status: Completed

Year Trial Started: 2006

Year Trial Ended: 2008

Study Type(s): Post-licensure Study/Evaluation

Principal Investigator: O'Brien, Katherine

Pathogen(s): Streptococcus pneumoniae

Product Category: Polysaccharide vaccine

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Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants

Project Number: 01-07-02-03-2

Project Status: Completed

Year Trial Started: 2001

Year Trial Ended: 2004

Study Type(s): Phase III Clinical Trial

Principal Investigator: O'Brien, Katherine

Pathogen(s): Rotavirus

IND(s): Merck and Co, Inc (Whitehouse Station, United States)

Product Category: Live attenuated vaccine

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Avian influenza
Borrelia
Botulinum toxin
Campylobacter jejuni
Dengue serotype 1
Dengue serotype 2
Dengue serotype 3
Dengue serotype 4
Diphtheria
E. coli
Enterotoxigenic E. coli H10407 (ETEC)
Haemophilus influenzae type b (Hib)
Hepatitis A
Hepatitis B
Hepatitis C
Human Immunodeficiency Virus (HIV)
Human metapneumovirus
Human Papilloma Virus
human parainfluenza virus 2
Influenza
Influenza A H1N1
Influenza A H2N2
Influenza A H6N1
Influenza H7N3
Influenza H7N7
Japanese Encephalitis
malaria
Measles
meningococcal disease
Mumps
Mycobacterium tuberculosis
Neisseria meningitidis
Norwalk virus
Parainfluenza Type 1
Parainfluenza Type 3
Pertussis
Plasmodium falciparum
Plasmodium vivax
pneumococcal disease
Poliovirus
Respiratory Syncytial Virus
Rotavirus
Rubella
Shigella flexneri
Staphylococcus aureus
Streptococcus pneumoniae
Tetanus
Tick-Borne Encephalitis
Typhoid
Varicella
Variola major
West Nile Virus
Yellow Fever Virus

Parainfluenza type 3 cp45 virus vaccine
Bovine parainfluenza virus type 3 vaccine
Parainfluenza Type 1 rHPIV1-84/del170/942A
Chimeric Bovine/Human Parainfluenza Type 3 Virus Vaccine
HPIV3-NB
rB/HPIV3 parainfluenza type 3 vaccine
Live influenza A vaccine modified H5N1 A/Vietnam/2004
Live influenza A vaccine H9N2
Live influenza A vaccine modified H5N1 A/Hong Kong/2003
cpts 248/955 respiratory syncytial virus vaccine
cpts 530/1009 respiratory syncytial virus vaccine
rA2cp248/404/1030ΔSH respiratory syncytial virus vaccine
cp 248/404/ΔSH respiratory syncytial virus vaccine
rA2/248/404/1030 (rA39) respiratory syncytial virus vaccine
rA2cp248/404/1030ΔSH (rA38) respiratory syncytial virus vaccine
rA2cp248/404ΔNS2 respiratory syncytial virus vaccine
rA2cpΔNS2 respiratory syncytial virus vaccine
cpts 248/404 respiratory syncytial virus vaccine
A2 purified F glycoprotein (PFP-2) respiratory syncytial virus vaccine
HNK20 IgA anti-RSV antibody
General Pneumococcal Conjugate Vaccine
General Hib Conjugate Vaccine
DTP vaccine
Measles vaccine
Typhoid vaccine
Japanese encephalitis vaccine
meningococcal conjugate vaccine
HIV vaccine
MMR (measles, mumps, rubella)
Live attenuated influenza vaccine
trivalent inactivated influenza vaccine
Bacillus Calmette-Guérin (BCG) vaccine
Pneumococcal vaccine
pneumococcal conjugate vaccine, tetanus carrier (PncT)
pneumococcal conjugage vaccine, diptheria carrier (PncD)
VAQTA TM (hepatitis A vaccine)
H6N1 Teal HK 97/AA ca recombinant vaccine
H7N3 (6-2) AA ca recombinant Influenza A vaccine
H2N2 1960 AA ca recombinant influenza A vaccine
H7N3 (6-2) AA ca recombinant influenza A vaccine
H7N7 (6-2) AA ca recombinant influenza A vaccine
DTwP/HBV/Hib combination vaccine
Hib vaccine
Hepatitis B vaccine
DTaP Diphtheria-tatanus-acellular-pertussis vaccine
HAVRIX hepatitis A vaccine
Pentavalent DTP, Hep B, Hib pediatric vaccine (Quinvaxem)
Yellow Fever vaccine
GARDASIL® HPV vaccine
Twinrix® hepatitis A and hepatitis B combination vaccine
ENGERIX-B® hepatitis B vaccine
Trivalent influenza vaccine, reduced thimerosal, Aventis Pasteur
Trivalent influenza vaccine, reduced thimerosal, PowderJect Pharmaceuticals
enhanced potency humanized RSV monoclonal antibody
pentavalent human bovine reassortant rotavirus vaccine
Prevnar® pneumococcal conjugate vaccine
Pneumovax® 23-valent pneumococcal polyscaccharide vaccine
ALVAC-HIV (vCP1452) canarypox HIV vaccine
V520 MRKAd5 HIV-1 Gag Vaccine
ALVAC-HIV (vCP205) canarypox HIV vaccine (Pasteur Merieux Connaught)
V520 MRKAd5 HIV-1 gag/pol/nef vaccine
HIV-1 SF-2 recombinant p24 subunit HIV vaccine (Chiron Vaccines)
HIV-1 SF-2 rgp120 in MF59 HIV vaccine (Chiron Vaccines)
ALVAC-HIV (vCP1433) canarypox HIV vaccine
HIV-1 MN rsgp120 HIV vaccine
Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) HIV vaccine
Multiclade recombinant adenoviral vector HIV-1 vaccine VRC-HIVDNA009-00-VP
recombinant DNA expressed lipo-protein Lyme disease vaccine LYMErix®
smallpox vaccine
quadrivalent human bovine UK reassortant rotavirus vaccine
human bovine double gene rotavirus reassortant vaccine (WaX DS1X UK)
cold-adapted influenza reassortant virus vaccine
DEN1Δ30 dengue 1 vaccine
DEN2/4Δ30 dengue 2 vaccine
rDEN3-3'D4Δ30 dengue 3 vaccine
rDEN3/4Δ30 dengue 3 vaccine
rDEN4Δ30-4995 dengue 4 vaccine
rDEN4Δ30-200,201 dengue 4 vaccine
rDEN4Δ30 dengue 4 vaccine
Tick-Borne Langat/Dengue 4 Chimera (LGT(TP21)/DEN4) vaccine
WN/DEN4Δ30 West Nile virus vaccine
WN/DEN4-3'Δ30 West Nile encephalitis vaccine
Pvs25H malaria vaccine
AMA1-C1/Alhydrogel® malaria vaccine
PpPfs25/ISA51 Plasmodium falciparum (malaria vaccine)
ScPvs25/ISA51 Plasmodium vivax (malaria vaccine)
MSP1(42)-C1/Alhydrogel® +/- CPG 7909 (plasmodium falciparum vaccine)
alphavirus replicon HIV-1 subtype C gag vaccine
gag DNA vaccine formulated with PBS (HIV-1 vaccine)
gag DNA vaccine formulated with AIP04 (HIV-1 vaccine)
HIV-1 SF-2 rgp120 HIV vaccine
Bivalent AIDSVAX B/B
Bivalent AIDSVAX B/MN rgp 120
LIPO-5 HIV vaccine
Enterotoxigenic E. coli (ETEC) H10407
ACE393 campylobacter jejuni vaccine
Campylobacter jejuni
Varicella vaccine
Oral polio vaccine (OPV)
MEDI-516 E. coli vaccine
rDEN3Δ30/31-7164 dengue 3 vaccine
rDEN2/4Δ30(ME) dengue 2 virus vaccine
TetraVax-DV dengue virus vaccine
rDEN4Δ30 Lot# 109A, dengue 4 virus vaccine
BSAM-2/Alhydrogel+CPG7909 malaria vaccine
CSL425 A/California/7/2009 (H1N1) influenza virus vaccine
rHMPV-Pa, lot HMPV #101A, human metapneumovirus vaccine
rHPIV2 15C/948L/∆1724 Lot PIV2#109C human parainfluenza 2 virus
rHMPV-SHs human metapneumovirus
RSV 248/404/PIV-3 cp 45 RSV/PIV-3 virus vaccine
rABcp/248/404/1030 respiratory syncytial virus
rABcp/248/404/ΔSH RSV virus vaccine
HIV-1 vaccine VRC-HIVDNA009-00-VP
CTL Multi-Epitope Peptide (Formulated With RC529-SE) HIV Vaccine
NefTat and gp120W61D combination HIV vaccine
V710 staph aureus vaccine 0657nI
Invaplex 50 intranasal shigella flexneri vaccine
ACE527 Enterotoxigenic Escherichia Coli (ETEC) vaccine
Norwalk VLP vaccine
S. typhi vaccube (Ty2 aroC– ssaV–) ZH9
HPV 16 L1/L2-E2-E7 VLP vaccine
Influenza DNA vaccine HA (georgia/93) (IDV) V510
Recombinant Hepatitis C Virus E2 Antigen with MF59 Adjuvant (Chiron HCV/MF59 Vaccine)
L1 HPV 16 VLP (HPV vaccine)
RC529-SE adjuvant
GM-CSF adjuvant
Biocine HBV vaccine
MF-59 adjuvant
RECOMBIVAX HB® HBV vaccine
RotaTeq® (Rotavirus vaccine)
pentavalent human-bovine reassortant rotavirus vaccine
monovalent attenuated human rotavirus vaccine
Shigella flexneri 2a strain SC602 vaccine
meningococcal vaccine

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