OBJECTIVE: To compare the safety of @entity327 type b (Hib) vaccine vaccination on vastus lateralis muscle and deltoid muscle of @entity1 . METHODS: A total of 408 3-4 months old @entity1 were divided into vastus lateralis muscle group and deltoid muscle group in Beijing, 2014. They were divided into the vastus lateralis muscle group (204) and deltoid muscle group (204) by extracting random number. Each observation object was given 3 doses of Hib vaccine according to the program. Collected systemic and local reactions after vaccination and calculated the incidence of adverse reactions. RESULTS: A total of 61 @entity1 were quitted during the study, 1 132 doses were observed. The total reactions incidence of Vastus lateralis muscle group and Deltoid muscle group were 33.0% (186/564) and 27.6% (157/568) with no statistical differences (  (2) = 3.818, P = 0.059). The two groups incidence at the same day of vaccination (day 0) which the highest were 23.2% (131/564) and 20.6% (117/568), then declined with time (linear trend test vastus lateralis muscle group   (2) = 36.600, P < 0.001,deltoid muscle group   (2) = 29.947, P < 0.001), day 1 were 20.4% (115/564) and 17.6% (100/568), day 2 were 16.0% (90/564) and 13.4% (76/568), day 3 were 10.3% (58/564) and 10.6% (60/568), day 4-7 were 11.2% (63/564) and 11.3% (64/568). No serious adverse events (SAE) were reported during the study. The local reactions incidence of two groups were 7.1% (40/564) and 7.7% (44/568)with no statistical differences (  (2) = 0.176, P = 0.675). The systemic reactions incidence of two groups were 25.9% (146/564) and 20.6% (117/568) with obvious statistical differences (  (2) = 4.437, P = 0.035). The @entity221 incidence of vastus lateralis muscle group (11.5% (65/564)) was higher than Deltoid muscle group (4.4% (25/568)) with obvious statistical differences (  (2) = 4.868, P = 0.027). The 1st dose incidence of @entity221 and abnormal crying of vastus lateralis muscle group ( @entity221 11.3% (23/204), abnormal crying 19.1% (39/204)) was higher than deltoid muscle group ( @entity221 4.4% (9/204), abnormal crying 11.8% (24/204)) and the 2nd dose of @entity294 of deltoid muscle group (11.6% (22/190)) was higher than vastus lateralis muscle group (5.9% (11/187)) with obvious statistical differences ( @entity221   (2) = 15.288, P < 0.001, abnormal crying   (2) = 4.224, P = 0.040, @entity294   (2) = 3.829, P = 0.046). CONCLUSION: Both vastus lateralis muscle group and deltoid muscle group had lower incidence of adverse reactions after vaccination. No serious adverse events were associated with vaccination. Vastus lateralis muscle vaccination as well as deltoid muscle vaccination demonstrated safe.

[Comparing the safety of vaccination on vastus lateralis muscle and deltoid muscle of @entity1 with XXXX type b conjugate vaccine].

@entity1 :: ('9606', 'Species') :: ['infants', 'infant'] @entity327 :: ('727', 'Species') :: ['haemophilus influenzae'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea']
@entity327 :: (727,Species) :: ['haemophilus influenzae']
