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Study Name (Link)
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Vaccine Type(s)*
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Manufacturer
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# Participants
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Status
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Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
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1-2 15µg doses
1-2 30µg doses
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Sanofi Pasteur
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202 age 18-64
204 age >65
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Found strong immune response after a single 15µg dose for most adults and potential benefit of a 30µg dose for the elderly
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CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
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1-2 15µg doses
1-2 30µg doses
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CSL
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200 age 18-64
208 age >65
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Found strong immune response after a single 15µg dose for most adults and potential benefit of a 30µg dose for the elderly
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Sanofi H1N1 + TIV** – Adults and Elderly
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Day 0: H1N1+ placebo
Day 21: H1N1+ placebo
Day 42: TIV
Day 0: H1N1+TIV
Day 21: H1N1+placebo
Day 42: Placebo
Day 0: H1N1+placebo
Day 21: H1N1+TIV
Day 42: Placebo
Day 0: TIV
Day 21: H1N1+placebo
Day 42: H1N1
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Sanofi Pasteur
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408 age 18-64
397 age >65
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Final results not yet published
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Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels with and without AS03 Adjuvant in Healthy Adult and Elderly Populations
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3.75µg + adjuvant
7.5µg + adjuvant
15µg + adjuvant
7.5µg, no adjuvant
15µg, no adjuvant
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Sanofi Pasteur
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544 age 18-64
245 age >65
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AS03 adjuvant was well tolerated, and significantly improved immune response at the 15µg dosage level.
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Novartis H1N1 Vaccine in Pregnant Women
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1-2 15µg doses
1-2 30µg doses
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Novartis
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59 pregnant
29 non-pregnant women
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Final results not yet published
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Sanofi Pasteur, TIV + H1N1, Pediatric Population
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Day 0: H1N1
Day 21: H1N1
Day 42: TIV
Day 0: H1N1+TIV
Day 21: H1N1
Day 0: H1N1
Day 21: H1N1+TIV
Day 0: TIV
Day 21: H1N1
Day 42: H1N1
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Sanofi Pasteur
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131 age 6-35 months
200 age 3-9 years
200 age 10-17 years
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Final results not yet published
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Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
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2 15µg doses
2 30µg doses
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Sanofi Pasteur
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192 age 6-35 months
197 age 3-9 years
200 age 10-17 years
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Final results not yet published
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H1N1 Vaccine in Pregnant Women
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2 15µg doses
2 30µg doses
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Sanofi Pasteur
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120 pregnant women age 18-39
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Found strong immune response after a single 25µg dose
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Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
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2 30 µg doses
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Novartis
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155 HIV positive children and youth age 4-25
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Two 30µg doses were found to be safe and immunogenic
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Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
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2 30µg doses
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Novartis
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130 HIV-positive adults age 18-64
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Final results not yet published
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H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
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2 15µg doses
2 30µg doses
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Novartis
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192 HIV-positive adults age 18-64
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Two 30µg doses were found to be more immunogenic than two 15µg doses
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Safety and Efficacy of an H1N1 Influenza Vaccine in People with Asthma
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2 15µg doses
2 30µg doses
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Novartis
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390 people with asthma age >12
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A single 15µg dose provided seroprotection for most participants regardless of asthma severity. However, the 30µg dose was more effective in the elderly, who had severe asthma. A second vaccination had no boosting effect. No safety concerns.
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