The largest clinical trial safety database (N=14,238) for an HBV vaccine12,13,16,17

The most common (>10%) local reaction was injection site pain (23%-39%), and the most common systemic reactions were fatigue (11%-17%) and headache (8%-17%)1

Percentage with local or systemic reactions within 7 days of vaccination: Trial 11

HEPLISAV-B
Post Dose:
Reaction 1 2
Local N=1810 N=1798
Injection Site Pain 38.5% 34.8%
Injection Site Redness* 4.1% 2.9%
Injection Site Swelling* 2.3% 1.5%
Systemic
Fatigue 17.4% 13.8%
Headache 16.9% 12.8%
Malaise 9.2% 7.6%
N=1784 N=1764
Fever 1.1% 1.5%
Engerix-B®
Post Dose:
Reaction 1 2 3
Local N=605 N=603 N=598
Injection Site Pain 33.6% 24.7% 20.2%
Injection Site Redness* 0.5% 1.0% 0.7%
Injection Site Swelling* 0.7% 0.5% 0.5%
Systemic  
Fatigue 16.7% 11.9% 10.0%
Headache 19.2% 12.3% 9.5%
Malaise 8.9% 6.5% 6.4%
N=596 N=590 N=561
Fever 1.8% 1.7% 1.8%

Percentage with local or systemic reactions within 7 days of vaccination: Trial 12

HEPLISAV-B
Post Dose:
Reaction 1 2
Local N=1952 N=1905
Injection Site Pain 23.7% 22.8%
Injection Site Redness* 0.9% 0.7%
Injection Site Swelling* 0.9% 0.6%
Systemic  
Fatigue 12.6% 10.8%
Headache 11.8% 8.1%
Malaise 7.7% 7.0%
Myalgia 8.5% 6.4%
N=1923 N=1887
Fever 0.6% 0.6%
Engerix-B®
Post Dose:
Reaction 1 2 3
Local N=477 N=464 N=448
Injection Site Pain 18.4% 15.9% 13.8%
Injection Site Redness* 0.6% 0.2% 0.2%
Injection Site Swelling* 0.6% 0.6% 0.2%
Systemic  
Fatigue 12.8% 12.1% 9.4%
Headache 11.9% 9.5% 8.5%
Malaise 8.6% 7.1% 5.1%
Myalgia 9.6% 8.0% 4.5%
N=472 N=459 N=438
Fever 0.6% 0.9% 0.7%

*Redness and swelling ≥2.5 cm.

Oral temperature ≥100.4°F [38.0°C].

Safety profile of HEPLISAV-B demonstrated in 3 pivotal clinical trials of over 10,000 subjects with up to 12 months of follow-up16

The percentage of subjects with an unsolicited adverse event1

Percentage who experienced adverse events after vaccination1

Trial 1
HEPLISAV-B
N=1810
Engerix-B
N=605
Within 28 days of
any injection
Unsolicited Adverse Events 42.0% 41.3%
Within 7 months of the
first vaccine dose
Serious Adverse Events 1.5% 2.1%
Immune-Mediated Adverse Events 0.2% 0.7%
Trial 2
HEPLISAV-B
N=1968
Engerix-B
N=481
Within 28 days of
any injection
Unsolicited Adverse Events 35.4% 36.2%
Within 12 months of the
first vaccine dose
Serious Adverse Events 3.9% 4.8%
Immune-Mediated Adverse Events 0.3% 0.0%
Trial 3
HEPLISAV-B
N=5587
Engerix-B
N=2781
Within 28 days of
any injection
Unsolicited Adverse Events 20.1% 20.1%
Within 13 months of the
first vaccine dose
Serious Adverse Events 6.2% 5.3%
Immune-Mediated Adverse Events 0.2% <0.1%

For Trial 3, only unsolicited medically-attended adverse events, those for which a subject sought medical care, were captured.

Engerix-B is a registered trademark of the GSK group of companies.



Study Results — Safety
HEPLISAV-B Hepatitis B Vaccine (Recombinant), Adjuvanted™ HEPLISAV-B Hepatitis B Vaccine (Recombinant), Adjuvanted™

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