Abstract
BackgroundPneumococcal infections are major causes of child mortality and morbidity worldwide and antibiotic resistance of Streptococcus pneumoniae is a major concern, especially in Asian countries. The present study was designed to evaluate the reactogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the licensed diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliovirus and H. influenzae type b vaccine (DTPa-HBV-IPV/Hib) in a 3-dose primary vaccination course in Vietnamese infants.MethodsThis phase III, open, randomised study was conducted in one centre in Ho Chi Minh City between February and July 2011. Healthy infants (N=300) were randomised (2:1) to receive either PHiD-CV co-administered with DTPa-HBV-IPV/Hib (PHiD-CV group) or DTPa-HBV-IPV/Hib alone (Control group) at 2, 3, and 4 months of age.ResultsWithin 31 days post-vaccination, 8.2% of overall doses in the PHiD-CV group and 3.0% of overall doses in the Control group were followed by at least one solicited and/or unsolicited, local and/or general adverse event of grade 3 intensity. Pain at injection site was the most common grade 3 solicited symptom, which was reported following 6.5% and 1.0% of overall doses in the PHiD-CV and Control groups, respectively. Within 4 days post-vaccination, the most common solicited local and general symptoms reported with any intensity were pain (48.9% and 31.0% of doses in the PHiD-CV and Control groups) and irritability (58.0% and 40.4% of doses in the PHiD-CV and Control groups). Within 31 days post-vaccination, the incidence of unsolicited symptoms was comparable in both groups (following 12.3% and 14.8% of doses in the PHiD-CV and Control groups, respectively). Throughout the study, 13 serious adverse events (SAEs) were reported in 9 infants in the PHiD-CV group and 11 SAEs in 6 infants in the Control group. None of them were fatal or considered causally related to vaccination.ConclusionsPHiD-CV had a clinically acceptable safety profile when co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. The reactogenicity of PHiD-CV was comparable to that observed in other South-East Asian populations. Trial registrationClinicalTrials.gov: http://NCT01153841
Highlights
Pneumococcal infections are major causes of child mortality and morbidity worldwide and antibiotic resistance of Streptococcus pneumoniae is a major concern, especially in Asian countries
Study objectives The primary objective of this study was to evaluate the safety and reactogenicity of 3-dose primary vaccination with PHiD-CV co-administered with DTPa-HBV-IPV/Haemophilus influenzae type b (Hib) in terms of grade 3 solicited adverse events (AEs) reported within 4 days post-vaccination and grade 3 unsolicited Adverse event (AE) reported within 31 days postvaccination in Vietnamese infants
The secondary objectives included the evaluation of the safety and reactogenicity in terms of local and general solicited AEs reported within 4 days after each vaccination, unsolicited AEs within 31 days after each vaccination, and serious adverse events (SAEs) throughout the study
Summary
Pneumococcal infections are major causes of child mortality and morbidity worldwide and antibiotic resistance of Streptococcus pneumoniae is a major concern, especially in Asian countries. In Vietnam, the incidence of invasive pneumococcal disease was estimated to be at least 48.7 cases per 100,000 children younger than 5 years of age in a previous study conducted in Khanh Hoa Province in 2005–2006 [2]. Routine vaccination of infants and toddlers with effective pneumococcal conjugate vaccines has been shown to be the best strategy to prevent invasive diseases caused by Streptococcus pneumoniae in children younger than 5 years of age, there is no pneumococcal conjugate vaccine currently available in Vietnam [8,9,10]. Previous clinical trials conducted in various countries have shown that PHiD-CV co-administered with routinely used childhood vaccines in infants or young children was immunogenic and had a clinically acceptable safety profile [11,12,13,14,15,16,17,18,19,20,21,22,23]
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