Table 1.

Overview of clinical studies providing safety data on the live attenuated SA 14–14–2 JE vaccine in children.

Year	Authors	Study country	Study design	Number of vaccinated children	Age of children	Number of vaccine doses	Concomitant vaccines	Duration of follow-up per child	Children with serious adverse events related to vaccine
1997	Liu32	China	Prospective randomized trial with control group, block randomization, of primary and booster immunization in Chengdu, Sichuan province; 1995	13,275	1, 2, 6 years	1 or 2 depending on age	None	30 d(subsample of 266 subjects were examined at days 1,2,3 and 7)	None
1999	Sohn24	South Korea	Prospective cohort study of primary immunization in 3 private chronic care facilities in Seoul (2) and Kyungki province (1); 1998	68	1–3 years	1	None	30 days	None
2008	Glovax22	South Korea	Post-marketing surveillance study of primary immunization in 8 research centers across South Korea; 2002–2008	606	10 months – 13 years	1	None	30 days	None
2008	Gatchalian8	Philippines	Prospective cohort study of primary immunization in a single center in Manila; 2005–2006	571	8–10 months	1	Measles	28 days	None
2011	Chotpitayasunondh25	Thailand	Prospective open-label single center trial of primary immunization in a single center in Bangkok; 2006–2007	150	9–15 months	1	None	28 days	None
2012	Ranganath26	India	Prospective cohort study of immunization campaign in Kolar, Karnataka; 2007	1,640	10–15 years	1	None	28 d	None
2013	Choi27	South Korea	Prospective cohort study of booster immunization in 3 tertiary level hospitals in South Korea; 2009–2010	68	5–7 years	1 booster(already received 1 or 2 doses previously at ages 1–2 years)	None	28 days	None
2014	Wijesinghe31	Sri Lanka	Prospective randomized open-label trial of primary immunization in a single center in Colombo; 2007–2008	278	9 months	1	Measles	1 y	None
2014	Liu23	China	Post-marketing surveillance study of 2- or 3-dose series in Guangdong, China; 2005–2012	23 million doses	8 months, 18–24 months, 6 years	3 dose series before 2009; 2 dose series post-2009 (ages 8 months 18–24 months)	Largely administered alone; some cases concurrently administered with measles only, measles-rubella, or diphtheria-tetanus-pertussis (acellular) vaccines	3 month reporting period via passive surveillance	36, including 2 deaths(difficult to assess causality)
2014	Wang21	China	Post-marketing surveillance study of primary immunization throughout 26 provinces in China; 2009–2012	62.39 million doses released (number of doses administered is unknown)	1–3 years	N/A	None	1 y	70, including 4 deaths(difficult to assess causality)
2014	Zaman35	Bangladesh	Lot-to-lot consistency randomized controlled trial of primary immunization in Matlab and Mirpur; 2012	818	10–12 months	1	None	28 days	None
2014	Feroldi33	Thailand	Observer-blind randomized controlled trial of primary immunization with LAJEV or JE-CV in 3 sites in Thailand; 2010	300	9–18 months	1	None	6 months	None
2014	Kim34	South Korea	Observer-blind randomized controlled trial of primary immunization with LAJEV or JE-CV in 10 sites in South Korea; 2011–2013	274	12–24 months	1	None	6 months	2
2015	Kwon28	South Korea	Prospective cohort study of 2-dose primary immunization in 5 centers across South Korea; 2007–2009	90	1–3 years	2 (1 y interval)	None	42 d after each vaccination	None
2016	Sanchayan29	Sri Lanka	Prospective cohort study of primary immunization in Jaffna district; 2012–2015	3,041	9 months	1	None	45 days	15
2016	Wijesinghe30	Sri Lanka	Open-label nonrandomized single arm study of primary immunization in children previously vaccinated with inactivated mouse brain- derived JE vaccine in Colombo district; 2007	305	2–5 years	1	None; Children who previously received 2 or 3 doses of inactivated mouse brain-derived JE vaccine, were again vaccinated with LAJEV	10 months	None

LAJEV = live, attenuated SA 14–14–2 JE vaccine; JE-CV = live, attenuated, recombinant (chimeric) JE vaccine.