Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan

Lin, Tzou Yien; Lu, Chun Yi; Chang, Luan‐Yin; Chiu, Cheng Hsun; Huang, Yhu Chering; Bock, Hans L.; Tang, Haïwen; François, Nancy; Moreira, Marta; Schuerman, Lode; Huang, Li Min

doi:10.1016/j.jfma.2011.07.014

Cited by 11 publications

(12 citation statements)

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“…In the present study, the reactogenicity and safety profile of PHiD-CV co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants seemed in line with that observed in previous studies, in which PHiD-CV was co-administered with routine childhood vaccines [13,21-23]. …”

Section: Discussionsupporting

confidence: 91%

“…In that study, the most frequently reported grade 3 solicited local and general symptoms were pain (following 4.2% of doses [95% CI: 2.8, 6.0]) and irritability (following 6.3% of doses [95% CI: 4.6, 8.4]) [21]. In another study, in which PHiD-CV was co-administered with a monovalent vaccine against Hib in Korean infants, grade 3 solicited symptoms were reported following no more than 2.6% of doses, which seems slightly lower than the reporting rates observed in the present study [22].…”

Section: Discussionmentioning

confidence: 99%

“…In contrast, redness was the most common solicited local symptom in previous Asian studies conducted in Taiwan and Korea, in which PHiD-CV was also co-administered with DTPa-based vaccines [21,22]. In the previous studies conducted in India and the Philippines, pain was also the most common solicited local symptom following co-administration of PHiD-CV and whole cell pertussis-based vaccines (following 71.0% of doses [95% CI: 67.6, 74.4] and 67.2% of doses [95% CI: 64.0, 70.3]) [13,23].…”

Section: Discussionmentioning

confidence: 99%

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Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

et al. 2013

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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

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

et al. 2013

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“…Nonetheless, as percentages of infants reaching threshold antibody concentrations and OPA titres for vaccine antigens were high and comparable in both groups, the observed differences in immunogenicity may be of limited clinical relevance. For each vaccine pneumococcal serotype, post-primary vaccination antibody GMCs seemed in line with those previously measured in Korea and Taiwan [ 16 , 19 ], and higher than in Europe [ 15 , 18 , 21 ]. Although it remains unclear why the magnitude of immune responses to pneumococcal conjugate vaccines varies in different populations, plausible explanations include genetic factors, early exposure to S. pneumoniae , or nasopharyngeal carriage of pneumococcal serotypes [ 36 ].…”

Section: Discussionsupporting

confidence: 86%

“…Although it remains unclear why the magnitude of immune responses to pneumococcal conjugate vaccines varies in different populations, plausible explanations include genetic factors, early exposure to S. pneumoniae , or nasopharyngeal carriage of pneumococcal serotypes [ 36 ]. Pre-vaccination antibody concentration, which is influenced by waning maternal antibodies and increasing adaptive immunity due to early exposure to S. pneumoniae, in Asian children was evaluated in a previous study conducted in Taiwan, where for each vaccine pneumococcal serotype the percentage of children with pre-vaccination antibody concentrations ≥0.2 μg/ml ranged from 11.5% to 42.5%, except serotype 14 (61%) [ 19 ]. Vaccine efficacy and effectiveness of pneumococcal conjugate vaccines have been demonstrated in various countries, hence clinical relevance of population differences remains unknown [ 37 – 42 ].…”

Section: Discussionmentioning

confidence: 99%

A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia

et al. 2014

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BackgroundThe immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed.MethodsIn the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18–21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA.ResultsImmune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ≥93.6% and ≥88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ≥0.2 μg/mL and OPA titres ≥8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ≥60.8% and ≥98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ≥0.2 μg/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ≤11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study.ConclusionsPHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2334-14-530) contains supplementary material, which is available to authorized users.

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10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D-Conjugate Vaccine: A Review in Infants and Children

Plosker

2014

Pediatr Drugs

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The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) (Synflorix™) includes ten serotype-specific polysaccharides of Streptococcus pneumoniae, eight of which are conjugated individually to a nonlipidated cell-surface lipoprotein (protein D) of non-typeable H. influenzae and two of which are conjugated to nontoxic tetanus or diphtheria toxoid carrier proteins. This article provides an overview of the well-established immunogenicity of PHiD-CV, including functional immune responses and immunologic memory, as well as immune responses in preterm infants and HIV-infected children. It also includes a brief discussion of cross-protection against vaccine-related serotypes (6A and 19A) and focuses on labelling in the EU, where PHiD-CV is approved for active immunization against invasive disease, pneumonia, and acute otitis media (AOM) caused by S. pneumoniae in infants and young children up to 5 years of age. Evidence of the protective efficacy and effectiveness of PHiD-CV against pneumococcal diseases is available from several studies, including the randomized, double-blind trials COMPAS (Clinical Otitis Media and Pneumonia Study) and FinIP (Finnish Invasive Pneumococcal disease), as well as postmarketing studies from various countries. As would be expected, protection against pneumonia or AOM is substantially lower than that against invasive pneumococcal disease, as many micro-organisms other than pneumococcal vaccine serotypes can cause pneumonia and AOM, thereby limiting the overall protection of PHiD-CV against these diseases. PHiD-CV has a safety and reactogenicity profile similar to that of other pneumococcal conjugate vaccines.

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Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan

Cited by 11 publications

References 37 publications

Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia

10-Valent Pneumococcal Non-Typeable Haemophilus influenzae Protein D-Conjugate Vaccine: A Review in Infants and Children

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