All other children completed all scheduled visits. Among children, 112 adverse events were recorded (Table 2): 108 (96%) were mild, 3 (2.7%) moderate and 1 (0.9%) was severe. Two of the moderate events were not regarded related to the vaccine. One participant had two isolated episodes of raised temperature in the first week post vaccination – the first, on day 1, was 41.1°C (severe) and the second, on day 5, was 38.1°C (moderate). These episodes were probably vaccine related, as they occurred during the first week post-vaccination. Seventy one (63%) of the 112 adverse events in children were local reactions at the site of vaccination; as in adolescents, these occurred

in all participants. The remainder were systemic adverse events, which manifested in the majority as a mild intercurrent illness with fifteen (13.4%) episodes of upper respiratory tract infections and seven (6.25%) episodes of loose stools. SCH 900776 Of these specific symptoms, only four children had upper GSK126 respiratory tract symptoms and two had loose stools in the first week after vaccination; these were classified as possibly vaccine related. The other events of this nature were evenly distributed across the 6-month follow-up period, with most occurring after a month post-vaccination.

The study was largely performed in autumn and winter, when viral infections are common. In addition, during upper respiratory tract infection swallowing of nasal secretions and phlegm are frequently associated with loose stools. For these reasons no viral cultures or further tests were done. All respiratory symptoms were mild in nature, of short duration and ranged from rhinitis, cough to sore throat and were infrequently associated with a recorded elevated temperature. Forty seven (42%) adverse events in children had resolved by the day 7 visit. Of those not Dimethyl sulfoxide resolved by day 7, 55 (49%) had resolved by day 28, 8 (7%) by day 84 and the remaining two (1.8%) by day 168. Adverse events that persisted beyond day 7 were all abnormal blood results, which included

a raised potassium level, raised liver function enzymes or raised platelets; none of these were considered definitely related to the vaccine. It is known that aspects of phlebotomy technique in children can cause raised potassium values. Overall, there were ten abnormalities in haematological and biochemical parameters in seven participants, as measured on days 7 and 84 post-vaccination. Overall, 49 (76%) and 69 (62%) adverse events in adolescents and children, respectively, were judged to be definitely related to the vaccine, 8 (13%) and 2 (2%) probably related, 3 (5%) and 17 (15%) possibly related, and 4 (6%) and 24 (21%) not vaccine related. M.tb infection status was assessed by measuring responses to early secretory antigenic target 6 (ESAT-6)/culture filtrate protein 10 (CFP-10) by IFN-γ ELISpot at every study visit.