Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197‐conjugated Haemophilus influenzae type b vaccine in healthy Chinese infants. Issue 10 (22nd August 2013)

• Record Type: Journal Article
• Authors: Jun, L.; Yuguo, C.; Zhiguo, W.; Jinfeng, L.; Huawei, M.; Xiuhua, L.; Yonggui, Z.; Yanhua, X.; Kong, Y.; Hongtao, L.; Yuliang, Z.
• Is Part Of: International journal of clinical practice. Volume 67:Issue 10(2013)
• Page Start: 971
• Page End: 978
• Publication Date: 2013-08-22
• Subjects: Clinical medicine -- Periodicals; Medicine -- Periodicals; 610.5
• DOI: 10.1111/ijcp.12267
• Languages: English
• ISSNs: 1368-5031

Abstract

<abstract abstract-type="main" id="ijcp12267-abs-0001"> <title>Summary</title> <sec id="ijcp12267-sec-0001" sec-type="section"> <title>Background</title> <p>Invasive meningitis and pneumonia caused by <italic>Haemophilus influenzae</italic> type b (Hib) is an important cause of childhood mortality in countries where Hib vaccination is not routine. We evaluated the non‐inferiority of a licensed Hib vaccine, PRP‐CRM<sub>197</sub> compared with a second licensed Hib vaccine, PRP‐T, following the recommended Chinese immunisation schedule for infants between 6 months and 1 year of age.</p> </sec> <sec id="ijcp12267-sec-0002" sec-type="section"> <title>Methods</title> <p>In the first study phase, 6–12 month‐old infants received two primary doses of either PRP‐CRM<sub>197</sub> (<italic>n</italic> = 335) or PRP‐T (<italic>n</italic> = 335) vaccine administered 1 month apart. In the second study phase 8 months later, the same children received a single booster dose of vaccine identical to that use for priming (PRP‐CRM<sub>197</sub>, <italic>n</italic> = 327; PRP‐T, <italic>n</italic> = 333). Serum levels of anti‐polyribosylribitol phosphate (PRP) antibodies were measured using enzyme‐linked immunosorbent assay (ELISA). Non‐inferiority of primary and booster doses was assessed in terms of percentages of subjects with anti‐PRP antibody levels associated with providing short‐term (≥ 0.15 μg/ml) and long‐term (≥ 1.0 μg/ml) protection; the non‐inferiority margin was set at −5%.</p> </sec> <sec id="ijcp12267-sec-0003" sec-type="section"> <title>Results</title> <p>PRP‐CRM<sub>197</sub> was demonstrated to be non‐inferior to PRP‐T. Anti‐PRP antibodies levels ≥ 0.15 μg/ml and ≥ 1.0 μg/ml were achieved by 97% of infants in the PRP‐CRM<sub>197</sub> group and 98% of infants in the PRP‐T group 1 month after primary immunisation, and by all subjects (100%) in both vaccine groups 1 month after booster administration. Safety profiles for both vaccines were similar; no serious adverse events, deaths or adverse events leading to withdrawal occurred during the study.</p> </sec> <sec id="ijcp12267-sec-0004" sec-type="section"> <title>Conclusion</title> <p>PRP‐CRM<sub>197</sub> was well‐tolerated and immunologically non‐inferior to a licensed comparator Hib vaccine in Chinese infants (Clinicaltrials.gov: NCT01044316 & NCT01226953).</p> </sec> </abstract>