Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five‐Component Pertussis‐Diphtheria‐Tetanus‐Inactivated Poliomyelitis‐<i>Haemophilus influenzae</i> Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age

Gold, Ronald; Barreto, Luis; Ferro, Santiago; Thippawong, John; Guasparini, Roland; Meekison, William; Russell, Margaret L.; Mills, Elaine L.; Harrison, Dana; Lavigne, Pierre

doi:10.1155/2007/289842

Cited by 15 publications

(50 citation statements)

References 38 publications

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“…The safety and immunogenicity of DTaP 5 -IPV-Hib using 3-dose primary vaccination schedules have previously been demonstrated in clinical studies in infants (1)(2)(3)(4)(5)(6)(7)(8) and toddlers (4,(9)(10)(11). This is the first study to have evaluated the 3-, 5-, and 12-month schedule employed in some countries, particularly in Europe, and to have compared the safety and immunogenicity of …”

mentioning

confidence: 95%

Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP₅), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP₃-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age

Vesikari¹,

Silfverdal²,

Boisnard³

et al. 2013

Clin. Vaccine Immunol.

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This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP 5 ), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP 5 -IPV-Hib) and DTaP 3 -IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP 5 -IPV-Hib to DTaP 3 -IPV/ Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP 5 -IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.) D iphtheria-tetanus toxoid-five-component acellular pertussis (DTaP 5 ), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP 5 -IPV-Hib) vaccine (Pediacel; Sanofi Pasteur Limited, Toronto, Ontario, Canada) is a fully liquid combination vaccine for primary and booster vaccination of infants and toddlers against infectious diseases caused by Clostridium tetani, Corynebacterium diphtheriae, Bordetella pertussis, Hib, and poliovirus types 1, 2, and 3. This licensed pentavalent vaccine comprises a 5-component acellular pertussis vaccine, adsorbed diphtheria and tetanus toxoids, inactivated poliomyelitis vaccine (IPV) grown in Vero cells, and a purified polyribosylribitol phosphate (PRP) capsular polysaccharide of Hib conjugated to tetanus toxoid. As a fully liquid formulation, DTaP 5 -IPV-Hib prevents dosing errors that can occur during reconstitution of vaccine components and may be more convenient for health care providers.The safety and immunogenicity of DTaP 5 -IPV-Hib using 3-dose primary vaccination schedules have previously been demonstrated in clinical studies in infants (1-8) and toddlers (4, 9-11). This is the first study to have evaluated the 3-, 5-, and 12-month schedule employed in some countries, particularly in Europe, and to have compared the safety and immunogenicity of (12). A modified double-blind design was utilized since the comparator vaccine (DTaP 3 -IPV/Hib) required reconstitution; an unblinded study team member prepared and administered study vaccines but was not involved in data collection. Parents/guardians were kept blinded to the identity of the study vaccine administered. The study complied with the Declaration of Helsinki. The study protocol and informed consent forms were approved by study site ethics committees. The participant parent(s) or legal guardian(s) provided written consent prior to study-specific procedures. The manuscript was prepared according to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals guidelines.Participants. Partici...

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mentioning

confidence: 95%

Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP₅), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP₃-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age

Vesikari¹,

Silfverdal²,

Boisnard³

et al. 2013

Clin. Vaccine Immunol.

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“…This section focuses primarily on six pivotal studies (namely A5I15, [22] A5I16, [15] A5I19, [23] PB9502, [24] PB9602, [25] and U01-A5I-302, parts I [26] and II; [27] n = 241-847) and, to a lesser extent, on three supporting studies (namely A5I06 [16] A5I09, [28] HE9810 A5I07, [29] HE9811; [30] n = 200-240), for which data are available. These trials, which were of randomized [15,16,[22][23][24][25][26][27][28][29][30] (open-label, [16,[26][27][28][29][30] single-blind, [15] or double-blind [22,23] ) design, were conducted at single [16,[28][29][30] or multiple [22][23][24][25][26][27] centers in the UK (U01-A5I-302 [26,27] ), Finland Sweden (A5I15 [22] ), France Poland (A5I16 [15] ), Germany (A5I19 [23] ), Canada (PB9502 …”

Section: Immunogenicitymentioning

confidence: 99%

“…Three supporting studies in which infants received DTaP-based combination vaccines other than Pediacel Ò (namely SWEDEN I [31] and II, [32] and study 494-03 [3] ) [21] are mentioned briefly, as are three other UK-based studies in which infants received Pediacel Ò . [19,20,33] Clinical studies of Pediacel Ò enrolled healthy infants who were between 6 weeks and 3 months of age when they received the first (of two [22] or three [15,16,19,20,[24][25][26]29,30,33] ) priming doses (administered at 6, 10, and 14 weeks, [29] 2, 3, and 4 months, [15,19,20,26,33] 2, 4, and 6 months, [16,24,25,30] or 3 and 5 months [22] ) and or 11-19 months of age when they received a booster dose; [15,[22][23][24][25]28] the latter constituted their first, [23] third, [22] or fourth [15,24,25,28] dose of Pediacel Ò .…”

Section: Immunogenicitymentioning

confidence: 99%

“…Pediacel Ò was either given alone [22,24,25] or coadministered with one or more doses of the following routine childhood vaccines: meningococcal group C conjugate (MCC) vaccine [19,20,26,33] (conjugated to tetanus toxoid [MCC-TT] [19,26,33] or conjugated to diphtheria-derived protein CRM197 [MCC-CRM]; [19,20,26] at 2, 3, and 4 months, [20,26] 2 and 3 months, [19] or 2 and 4 months [19,33] ); pneumococcal conjugate vaccine [15,19,20,23,33] (7-valent [PCV7] [15,19,20,23,33] or 13-valent [PCV13]; [33] at 2, 3, and 4 months, [20] 2 and 3 months, [19] or 2 and 4 months [19,33] ); and HBV vaccine [16,23,29,30] (at 6 and 14 weeks, [29] 6 months, [16,30] or 11-18 months [23] ).…”

Section: Immunogenicitymentioning

confidence: 99%

“…Comparator vaccines in active-controlled studies of Pediacel Ò included hexavalent (Infanrix hexa Ò [23] ), pentavalent (Pentacel Ò [24] and Infanrix Ò -IPV+Hib [15,22] ), and quadrivalent (Quadracel Ò [16,24,28] and Actacel Ò [29,30] ) DTaP-based combination products; the quadrivalent vaccines were given concomitantly with monovalent vaccines (Act-Hib Ò [16,24,28] or oral poliomyelitis vaccine [OPV] [29,30] ). Other comparators included pentavalent (Pentact-Hib Ô [30] ) and quadrivalent (TetrActHib Ò [26,29] ) diphtheria and tetanus toxoid and whole-cell pertussis (DTwP)-based combination products; the quadrivalent vaccine was given concomitantly with OPV.…”

Section: Immunogenicitymentioning

confidence: 99%

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DTaP5-IPV-Hib Vaccine (Pediacel®)

Frampton

2011

Pediatric Drugs

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Pediacel® is a fully liquid formulation of a diphtheria, tetanus, five-component acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b combination vaccine, which does not require reconstitution. Both vial and prefilled syringe presentations of Pediacel® are available for use in the EU. In active-controlled clinical trials, primary and/or booster vaccination with Pediacel® was highly immunogenic, eliciting strong and sustained serologic responses against all its component toxoids/antigens when administered according to a variety of different schedules. In particular, pivotal studies showed that Pediacel® was generally similar and/or noninferior to reconstituted pentavalent and hexavalent diphtheria, tetanus, and acellular pertussis-based combination vaccines in terms of the seroprotection rates elicited against the diphtheria, tetanus, poliovirus, and Haemophilus influenzae type b components that these products have in common, as well as in terms of the seroresponse/booster response rates elicited against the acellular pertussis components that these products have in common. Differences in immune responses between Pediacel® and these vaccines were considered unlikely to be clinically significant. There was no clear evidence of clinically relevant changes in the immunogenicity of Pediacel® (or the coadministered vaccine) when given concomitantly with meningococcal group C conjugate, pneumococcal conjugate, or hepatitis B vaccines in clinical studies. Pediacel® was generally well tolerated and demonstrated low reactogenicity in clinical trials. It had an adverse event profile generally similar to that of other combination vaccines based on diphtheria, tetanus and acellular pertussis vaccine, including Infanrix®-IPV+Hib and Infanrix® hexa.

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Cost‐minimization analysis of DTaP‐IPV‐Hib combination vaccine in China: A nationwide cross‐sectional study

Liu

Cao

Wang

et al. 2022

Journal of Medical Virology

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Combination vaccines can reduce the vaccination visit, simplify the vaccination schedule and efficiently improve management. This study was primarily designed to evaluate the economic impact of integrating the diphtheria‐tetanus‐acellular pertussis inactivated poliomyelitis and Haemophilus influenzae type B (DTaP‐IPV‐Hib) combination vaccine into the China National Immunization Program. A cost‐minimization analysis (CMA) compared the costs associated with direct medical, direct nonmedical, and indirect social costs in four schemes was conducted. A budgetary impact analysis assessed the alternative schemes' financial impact on the healthcare budget. Direct medical costs were extracted using a costing questionnaire and an observational time and motion chart. Direct nonmedical (cost for transportation) and indirect costs (loss of productivity) were derived from parents' questionnaires. Replacement of the current vaccination scheme with DTaP‐IPV‐Hib combination vaccine, resulted in net increases in direct medical costs of 77.64% for alternative scheme 1, 146.54% for alternative scheme 2, and 294.67% for alternative scheme 3, respectively. However, the direct nonmedical and indirect costs and the cost of the alternative schemes were 18.18%, 36.36%, and 63.64% lower than the current scheme for alternative scheme 1, alternative scheme 2, and alternative scheme 3, respectively. From the societal perspective, when compared with the current scheme, the budgetary impact of the three alternative schemes were +66 million Chinese Yuan (CNY) (4.81%), +103 million CNY (7.53%), and +305million CNY (22.35%), respectively. The CMA considered a broader perspective of social costs and indicated that the alternative schemes would result in an overall saving of parents' transportation and work loss costs to bring their children for vaccination, translating into a total cost saving of 18.18%, 36.36%, 63.64%, comparing to the current scheme. Thus, fully or partly using the DTaP‐IPV‐Hib combination vaccine is cost‐saving in the context of China.

show abstract

Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five‐Component Pertussis‐Diphtheria‐Tetanus‐Inactivated Poliomyelitis‐Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age

Abstract: The fully liquid combination vaccine was comparable in terms of safety and immunogenicity with the reconstituted combination vaccine.

Cited by 15 publications

References 38 publications

DTaP5-IPV-Hib Vaccine (Pediacel®)

Cost‐minimization analysis of DTaP‐IPV‐Hib combination vaccine in China: A nationwide cross‐sectional study

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