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H1N1 (Swine) Flu

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2009 H1N1 Influenza Vaccine Clinical Trials

NIAID launched a series of clinical trials in August 2009 to evaluate H1N1 influenza vaccines developed in response to the 2009-2010 H1N1 influenza pandemic. NIAID’s goals were to make sure that the new vaccines would be effective and safe. The trials were designed to show how many doses and what size dose(s) would be needed per person, including healthy adults, elderly people, children, pregnant woman, people with asthma and people with HIV. Trials also investigated whether the H1N1 vaccine would be tolerated in the presence of the seasonal flu vaccine and whether adjuvants increased the efficacy of the H1N1 vaccine.

Study Name (Link)

Vaccine Type(s)*

Manufacturer

# Participants

Status

Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

1-2 15µg doses
1-2 30µg doses

Sanofi Pasteur

202 age 18-64
204 age >65

Found strong immune response after a single 15µg dose for most adults and potential benefit of a 30µg dose for the elderly

CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

1-2 15µg doses
1-2 30µg doses

CSL

200 age 18-64
208 age >65

Found strong immune response after a single 15µg dose for most adults and potential benefit of a 30µg dose for the elderly

Sanofi H1N1 + TIV** – Adults and Elderly

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

Sanofi Pasteur

408 age 18-64
397 age >65

Final results not yet published

Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels with and without AS03 Adjuvant in Healthy Adult and Elderly Populations

3.75µg + adjuvant
7.5µg + adjuvant
15µg + adjuvant
7.5µg, no adjuvant
15µg, no adjuvant

Sanofi Pasteur

544 age 18-64
245 age >65

AS03 adjuvant was well tolerated, and significantly improved immune response at the 15µg dosage level.

Novartis H1N1 Vaccine in Pregnant Women

1-2 15µg doses
1-2 30µg doses

Novartis

59 pregnant
29 non-pregnant women

Final results not yet published

Sanofi Pasteur, TIV + H1N1, Pediatric Population

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

 

Sanofi Pasteur

131 age 6-35 months
200 age 3-9 years
200 age 10-17 years

Final results not yet published

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

2 15µg doses
2 30µg doses

Sanofi Pasteur

192 age 6-35 months
197 age 3-9 years
200 age 10-17 years

Final results not yet published

H1N1 Vaccine in Pregnant Women

2 15µg doses
2 30µg doses

Sanofi Pasteur

120 pregnant women age 18-39

Found strong immune response after a single 25µg dose

Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

2 30 µg doses

Novartis

155 HIV positive children and youth age 4-25

Two 30µg doses were found to be safe and immunogenic

Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

2 30µg doses

Novartis

130 HIV-positive adults age 18-64

Final results not yet published

H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

2 15µg doses
2 30µg doses

Novartis

192 HIV-positive adults age 18-64

Two 30µg doses were found to be more immunogenic than two 15µg doses

Safety and Efficacy of an H1N1 Influenza Vaccine in People with Asthma

2 15µg doses
2 30µg doses

Novartis

390 people with asthma age >12

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.

* Unless otherwise noted, doses refer to 2009 H1N1 influenza vaccine.

** Trivalent inactivated vaccine.

Last Updated June 27, 2012

Last Reviewed June 27, 2012