To the editor: Response to Willame, et al., published in Vaccine 35 (2017) 5551–5558, entitled “Pain caused by measles, mumps, and rubella vaccines: A systematic literature review”
Two of the studies (ref. 22, 21) were very small, with 49 and 60 subjects respectively [3,4]. Because of the small number and size of these studies, additional data are needed to draw firm conclusions. [...]with respect to pain within days of vaccination, the review did not include 2 recent, large r...
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| Published in | Vaccine Vol. 36; no. 45; pp. 6587 - 6588 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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Elsevier Ltd
29.10.2018
Elsevier Limited |
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| Abstract | Two of the studies (ref. 22, 21) were very small, with 49 and 60 subjects respectively [3,4]. Because of the small number and size of these studies, additional data are needed to draw firm conclusions. [...]with respect to pain within days of vaccination, the review did not include 2 recent, large randomized, comparative studies which show similar rates of injection-site pain for Priorix and M-M-RII. The data on injection-site pain from these two studies is summarized in the table below, and shows no notable difference between Priorix and M-M-RII (note overlapping 95% confidence intervals):StudySymptomIntensityPriorix®M-M-R®IINn%(95% CI)Nn%(95% CI)115,648 (MMR-160)PainAny*355591925.9(24.4, 27.3)124234928.1(25.6, 30.7)Grade 3†240.7(0.4, 1.0)121.0(0.5, 1.7)115,650 (MMR-162)PainAny*112231127.7(25.1, 30.4)55413223.8(20.3, 27.6)Grade 3†60.5(0.2, 1.2)20.4(0.0, 1.3)N = number of subjects with available results.n/% = number/percentage of subjects with concentration equal to or above specified value.95% CI = 95% confidence interval.*Any Pain = occurrence of any local symptom regardless of their intensity grade.†Grade 3 Pain = cried when limb was moved/spontaneously painful.The preponderance of evidence supports that post-vaccination pain is similar between Priorix and M-M-R II. |
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| AbstractList | Two of the studies (ref. 22, 21) were very small, with 49 and 60 subjects respectively [3,4]. Because of the small number and size of these studies, additional data are needed to draw firm conclusions. [...]with respect to pain within days of vaccination, the review did not include 2 recent, large randomized, comparative studies which show similar rates of injection-site pain for Priorix and M-M-RII. The data on injection-site pain from these two studies is summarized in the table below, and shows no notable difference between Priorix and M-M-RII (note overlapping 95% confidence intervals):StudySymptomIntensityPriorix®M-M-R®IINn%(95% CI)Nn%(95% CI)115,648 (MMR-160)PainAny*355591925.9(24.4, 27.3)124234928.1(25.6, 30.7)Grade 3†240.7(0.4, 1.0)121.0(0.5, 1.7)115,650 (MMR-162)PainAny*112231127.7(25.1, 30.4)55413223.8(20.3, 27.6)Grade 3†60.5(0.2, 1.2)20.4(0.0, 1.3)N = number of subjects with available results.n/% = number/percentage of subjects with concentration equal to or above specified value.95% CI = 95% confidence interval.*Any Pain = occurrence of any local symptom regardless of their intensity grade.†Grade 3 Pain = cried when limb was moved/spontaneously painful.The preponderance of evidence supports that post-vaccination pain is similar between Priorix and M-M-R II. |
| Author | Lee, Andrew W. Saldutti, Louise P. Stek, Jon E. Wolfson, Lara J. Kuter, Barbara J. |
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| Cites_doi | 10.1016/j.vaccine.2017.08.068 10.1016/j.vaccine.2012.03.085 10.1093/ofid/ofw194.112 10.1001/archpedi.158.4.323 |
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| References | Henry O, Klein NP, Povey M, Parra MM, Diez-Domingo J, Ahonen A, et al. A Randomized, Consistency Study Comparing Immunogenicity and Safety of 2 Vaccines against Measles, Mumps and Rubella (MMR) Administered to Children 12–15 Months of Age [abstract 1685]. Presented at: Infectious Diseases Week, 2016; New Orleans, LA. Available at Ipp, Cohen, Goldbach, Macarthur (b0015) 2006; 13 GlaxoSmithKline Biologics. Consistency study of GSK Biologicals’ MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine (M-M-R®II), in healthy children 12 to 15 months of age; Study Number 115648 (MMR-160). Available at Gidudu, Walco, Taddio, Zempsky, Halperin, Calugar (b0010) 2012; 30 Ipp, Cohen, Goldbach, Macarthur (b0020) 2004; 158 GlaxoSmithKline Biologics. Safety and immunogenicity study of GSK Biologicals’ MMR vaccine (209762) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine, in healthy children 12 to 15 months of age; Study Number 115650 (MMR-162). Available at Willame, Henry, Lin, Vetter, Baril, Praet (b0005) 2017 Oct 9; 35 . [accessed: 08-Dec-2017]. Willame (10.1016/j.vaccine.2018.08.024_b0005) 2017; 35 Ipp (10.1016/j.vaccine.2018.08.024_b0020) 2004; 158 Gidudu (10.1016/j.vaccine.2018.08.024_b0010) 2012; 30 Ipp (10.1016/j.vaccine.2018.08.024_b0015) 2006; 13 10.1016/j.vaccine.2018.08.024_b0030 10.1016/j.vaccine.2018.08.024_b0025 10.1016/j.vaccine.2018.08.024_b0035 |
| References_xml | – reference: [accessed: 08-Dec-2017]. – reference: GlaxoSmithKline Biologics. Consistency study of GSK Biologicals’ MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine (M-M-R®II), in healthy children 12 to 15 months of age; Study Number 115648 (MMR-160). Available at: – reference: GlaxoSmithKline Biologics. Safety and immunogenicity study of GSK Biologicals’ MMR vaccine (209762) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine, in healthy children 12 to 15 months of age; Study Number 115650 (MMR-162). Available at: – reference: Henry O, Klein NP, Povey M, Parra MM, Diez-Domingo J, Ahonen A, et al. A Randomized, Consistency Study Comparing Immunogenicity and Safety of 2 Vaccines against Measles, Mumps and Rubella (MMR) Administered to Children 12–15 Months of Age [abstract 1685]. Presented at: Infectious Diseases Week, 2016; New Orleans, LA. Available at: – volume: 158 start-page: 323 year: 2004 end-page: 326 ident: b0020 article-title: Effect of choice of measles-mumps-rubella vaccine on immediate vaccination pain in infants publication-title: Arch Pediatr Adolesc Med – volume: 30 start-page: 4558 year: 2012 end-page: 4577 ident: b0010 article-title: Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data publication-title: Vaccine – volume: 13 start-page: e296 year: 2006 end-page: e299 ident: b0015 article-title: Pain response to MMR vaccination in 4–6 year old children publication-title: Can J Clin Pharmacol – reference: . – volume: 35 start-page: 5551 year: 2017 Oct 9 end-page: 5558 ident: b0005 article-title: Pain caused by measles, mumps, and rubella vaccines: a systematic literature review publication-title: Vaccine – volume: 35 start-page: 5551 issue: 42 year: 2017 ident: 10.1016/j.vaccine.2018.08.024_b0005 article-title: Pain caused by measles, mumps, and rubella vaccines: a systematic literature review publication-title: Vaccine doi: 10.1016/j.vaccine.2017.08.068 – volume: 30 start-page: 4558 issue: 30 year: 2012 ident: 10.1016/j.vaccine.2018.08.024_b0010 article-title: Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data publication-title: Vaccine doi: 10.1016/j.vaccine.2012.03.085 – ident: 10.1016/j.vaccine.2018.08.024_b0030 – volume: 13 start-page: e296 year: 2006 ident: 10.1016/j.vaccine.2018.08.024_b0015 article-title: Pain response to MMR vaccination in 4–6 year old children publication-title: Can J Clin Pharmacol – ident: 10.1016/j.vaccine.2018.08.024_b0025 doi: 10.1093/ofid/ofw194.112 – ident: 10.1016/j.vaccine.2018.08.024_b0035 – volume: 158 start-page: 323 year: 2004 ident: 10.1016/j.vaccine.2018.08.024_b0020 article-title: Effect of choice of measles-mumps-rubella vaccine on immediate vaccination pain in infants publication-title: Arch Pediatr Adolesc Med doi: 10.1001/archpedi.158.4.323 |
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| SubjectTerms | Allergy and Immunology Comparative studies Confidence intervals Immunization Injection Literature reviews Measles Mumps Pain Rubella Vaccines |
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| Title | To the editor: Response to Willame, et al., published in Vaccine 35 (2017) 5551–5558, entitled “Pain caused by measles, mumps, and rubella vaccines: A systematic literature review” |
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