Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: A randomized, controlled, open-label, multicenter study

Chatterjee, Archana; O’Keefe, Catherine; Varman, Meera; Klein, Nicola P.; Luber, Stephen; Tomovici, Antigona; Noriega, Fernando

doi:10.1016/j.vaccine.2012.03.057

Cited by 9 publications

(6 citation statements)

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“…Abbreviations: CI, confidence interval; EU, ELISA units; FHA, filamentous hemagglutinin; FIM, fimbriae 2 and 3; GMC, geometric mean concentration; PRN, pertactin; PT, pertussis toxoid; Td, tetanus-diphtheria; Tdap, tetanus, diphtheria, and acellular pertussis; ELISA, enzyme-linked immunosorbent assay; TNA, toxin neutralization assay. a Group 2: for PT GMCs, group 2 represents the group of participants in the M5A10 clinical trial who received 4 doses of DTaP [21]. For FHA, PRN, and FIM, group 2 represents the group of participants from the Sweden I clinical trial who received 3 doses of DTaP [20].…”

Section: Resultsmentioning

confidence: 99%

“… a Group 2: for PT GMCs, group 2 represents the group of participants in the M5A10 clinical trial who received 4 doses of DTaP [21]. For FHA, PRN, and FIM, group 2 represents the group of participants from the Sweden I clinical trial who received 3 doses of DTaP [20].…”

Section: Resultsmentioning

confidence: 99%

“…The reasons for the higher prevaccination concentrations of antibodies to PRN and FIM are unknown but might be the result of natural boosting of these antibodies via exposure to pertussis or other species of Bordetella or other infectious agents such as Mycoplasma pneumoniae and Chlamydia pneumoniae [23–25]. Although the booster response rates were lower than the prespecified thresholds derived from previous clinical trials with the same Tdap vaccine [22], the postvaccination GMCs met noninferiority testing and they were 2.9- and 2.2-fold higher, respectively, in the Tdap group than in prespecified historical DTaP controls [20, 21]. Also, in the current study, the Tdap vaccine induced 6.4- and 5.2-fold increases (postvaccination-to-prevaccination ratios) in PRN and FIM antibodies, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…The hypotheses for the primary end points were that the proportion of participants who achieved a postvaccination tetanus antibody concentration of ≥0.1 IU/mL and booster response would be noninferior in Tdap vaccine recipients compared to Td recipients; the anti-pertussis antibody GMCs induced by Tdap vaccine would be noninferior to those induced by 3 (for FHA, PRN, and FIM) or 4 (for PT) doses of diphtheria, tetanus, acellular pertussis (DTaP) vaccine given to infants and toddlers in prelicensure clinical trials [20, 21]; and pertussis booster responses induced by revaccination with Tdap vaccine would be noninferior to expected booster responses derived from the use of Tdap vaccine in people aged 21 to <65 years in a pivotal prelicensure clinical trial [22]. Noninferiority of GMCs was declared if the lower bound of the 2-sided 95% CI of the ratio Tdap vaccine to comparator was >0.66, and noninferiority of the booster responses was declared if the lower bound of the 95% CI of the difference in proportions was greater than −10%.…”

Section: Methodsmentioning

confidence: 99%

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Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose

Halperin

Donovan

Marshall

et al. 2018

Journal of the Pediatric Infectious Diseases Society

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose

Halperin

Donovan

Marshall

et al. 2018

Journal of the Pediatric Infectious Diseases Society

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“…Safety and immunogenicity of different multivalent pertussis vaccines in infants and toddlers [ 15 ].…”

Section: Study Highlightsmentioning

confidence: 99%

Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012

Baxter

Klein

2013

Vaccines

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Soares‐Weiser

Bergman

Henschke

et al. 2019

Cochrane Database of Systematic Reviews

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BackgroundRotavirus results in more diarrhoea‐related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea‐related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by the World Health Organization (WHO) include a monovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech).ObjectivesTo evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children.Search methodsOn 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews.Selection criteriaWe selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention.Data collection and analysisTwo review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross‐checked them. We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI). We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty.Main resultsFifty‐five trials met the inclusion criteria and enrolled a total of 216,480 participants. Thirty‐six trials (119,114 participants) assessed RV1, 15 trials (88,934 participants) RV5, and four trials (8432 participants) Rotavac.RV1Children vaccinated and followed up the first year of lifeIn low‐mortality countries, RV1 prevents 84% of severe rotavirus diarrhoea cases (RR 0.16, 95% CI 0.09 to 0.26; 43,779 participants, 7 trials; high‐certainty evidence), and probably prevents 41% of cases of severe all‐cause diarrhoea (RR 0.59, 95% CI 0.47 to 0.74; 28,051 participants, 3 trials; moderate‐certainty evidence). In high‐mortality countries, RV1 prevents 63% of severe rotavirus diarrhoea cases (RR 0.37, 95% CI 0.23 to 0.60; 6114 participants, 3 trials; high‐certainty evidence), and 27% of severe all‐cause diarrhoea cases (RR 0.73, 95% CI 0.56 to 0.95; 5639 participants, 2 trials; high‐certainty evidence).Children vaccinated and followed up for two yearsIn low‐mortality countries, RV1 prevents 82% of severe rotavirus diarrhoea cases (RR 0.18, 95% CI 0.14 to 0.23; 36,002 participants, 9 trials; high‐certainty evidence), and probably prevents 37% of severe all‐cause diarrhoea episodes (rate ratio 0.63, 95% CI 0.56 to 0.71; 39,091 participants, 2 trials; moderate‐certainty evidence). In high‐mortality countries RV1 probably prevents 35% of severe rotavirus diarrhoea cases (RR 0.65, 95% CI 0.51 to 0.83; 13,768 participants, 2 trials; high‐certainty ev...

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Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: A randomized, controlled, open-label, multicenter study

Cited by 9 publications

References 11 publications

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose

Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012

Vaccines for preventing rotavirus diarrhoea: vaccines in use

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