Search strategies and full references of included studies

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1 Search strategies and full references of included studies Pneumococcal conjugate vaccine schedules comparing 3 with 2 primary doses: A systematic review and metaanalysis Pippa Scott, 1 Anne W.S. Rutjes, 1,2 Lilian Bermetz, 1 Nadège Robert, 1 Susana Scott, 3 Tania Lourenço, 4 Matthias Egger, 1 Nicola Low Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland. 2. Center for Aging Sciences (Ce.S.I.), University G. d'annunzio Foundation, Chieti, Italy. 3. Department of Infectious Disease Epidemiology (IDE), London School of Hygiene and Tropical Medicine (LSHTM), United Kingdom. 4. Health Services Research Unit (HSRU), University of Aberdeen, United Kingdom. 1

Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland. 2. Center for Aging Sciences (Ce.S.I.), University G.

2 Databases and registries searched Medline and Embase (in Embase.com); the Cochrane Library; African Index Medicus (AIM); the Indian Medlars Centre (IndMed); Latin American and Caribbean Health Sciences (LILACs); Current Controlled Trials metaregister of Controlled Trials (mrct, active and archived registers); UK Clinical Trials Gateway (UKCTG); US Food and Drug Administration (FDA); European Public Assessment Report (EPAR) listings of the European Medicines Agency (EMEA); WHO International Clinical Trials Registry Platform Search Portal (includes ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register (ISRCTN) and clinical trial registries of Australia, China, Germany, India, Iran, The Netherlands, New Zealand, Sri Lanka); GSK Clinical Study Register; and Clinicalstudyresults.org (includes Wyeth trial listings). 2

Controlled Trials (mrct, active and archived registers); UK Clinical Trials Gateway (UKCTG); US Food and Drug Administration (FDA); European Public Assessment Report (EPAR) listings of the European

3 Search strategies Embase.com ( ( ('pneumococcus vaccine'/syn) ('pneumococcal vaccine'/syn) (pneumococcal AND 'vaccine'/syn) (('vaccine'/syn) AND ('pneumococcus'/syn)) ((('vaccine'/syn) ('immunization'/syn) (vacc*:ab,ti) (immuni?ation*:ab,ti)) AND (pneumococc*:ab,ti)) ((pneumococc*:de) AND (vacc*:de)) ((pneumococc*:de) AND (immuni?ation*:de)) (pneumococcal AND ('vaccine'/exp 'vaccine')) ('pneumococcal vaccine'/exp 'pneumococcal vaccine') (pneumococcal AND ('vaccination'/exp 'vaccination')) ('pneumococcal vaccination') ((('vaccine'/syn) ('immunization'/syn) (vacc*:ab,ti) (immuni?ation*:ab,ti)) AND (((strep*:ab,ti) AND (pneumoniae:ab,ti)) ('streptococcus pneumoniae'/syn))) ) ((('vaccine'/syn) ('immunization'/syn) (vacc*:ab,ti) (immuni?ation*:ab,ti)) AND (('pneumococcal infection'/syn) ((('infection'/syn) (infection*:ab,ti) (disease*:ab,ti)) AND (pneumococc*:ab,ti)) ((('infection'/syn) (infection*:ab,ti) (disease*:ab,ti)) AND (((strep*:ab,ti) AND (pneumoniae:ab,ti)) ('streptococcus pneumoniae'/syn))))) ) AND (('conjugate'/syn) (conjug*:ab,ti) (conjug*)) The Cochrane Library ((pneumoco* strep*) AND (vaccine* immuni*) AND conjugate*) (MeSH Desriptor "pneumococcal vaccines" explode all trees AND conjugate*) 3

(immuni?ation*:ab,ti)) AND (pneumococc*:ab,ti)) ((pneumococc*:de) AND (vacc*:de)) ((pneumococc*:de) AND (immuni?

4 African Index Medicus (AIM) pneumococc$ strep$ The Indian Medlars Centre (IndMed) (pneumococc$ strep$) AND (vaccin$ immuni$) Latin American and Caribbean Health Sciences (LILACs) (pneumococc$ strep$) AND (vaccin$ immuni$) AND conjugate$ Current Controlled Trials metaregister of Controlled Trials : active registers (pneumococc* strep*) AND (vaccine* immuni*) AND conjugate* archived registers pneumococc* UK Clinical Trials Gateway (UKCTG) pneumococc* US Food and Drug Administration (FDA) Prevnar European Public Assessment Report (EPAR) listings of the European Medicines Agency (EMEA) Prevenar Synflorix WHO International Clinical Trials Registry Platform Search Portal (pneumococc* strep*) AND (vaccine* immuni*) AND conjugate* GSK Clinical Study Register Search of any condition or substance relating to pneumococcus listed on GSK website Clinicalstudyresults.org Prevnar Prevenar Synflorix 4

pneumococc* UK Clinical Trials Gateway (UKCTG) pneumococc* US Food and Drug Administration (FDA) Prevnar European Public Assessment Report (EPAR) listings of the European Medicines Agency (EMEA)

5 Full reference list Europe (Denmark, Norway, Slovakia, Sweden) 10v (1-3) Fiji 7v (4-9) Gambia 7v (10), and unpublished report Ghana 9v (sickle-cell) (11), and unpublished article Iceland 9v (12, 13) Israel 7v (14-20) UK1 9v (21) UK2 9v (21) UKobs 9v (21) USAobs 7v (22) 1. Silfverdal SA, Hogh B, Bergsaker MR, Skerlikova H, Lommel P, Borys D, et al. Immunogenicity of a 2-Dose priming and booster vaccination with the 10-Valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine. The Pediatric Infectious Disease Journal. 2009;28:e276 e GlaxoSmithKline. An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a months vaccination schedule. Study No (10PN-PD-DIT-002). Available from: [accessed August 17, 2011]. 3. European Medicines Agency (EMEA). Synflorix. Available from: 3/human_med_ jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac d125 [accessed August 17, 2011]. 4. Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, et al. Pneumococcal nasopharyngeal carriage following reduced doses of a 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster. Clin Vaccine Immunol Dec;17(12): Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, et al. Pneumococcal nasopharyngeal carriage following a reduced dose 7-valent pneumococcal conjugate vaccine schedule in infancy and 23-valent pneumococcal polysaccharide vaccine booster. Abstract no 405, 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), March 14-18, Tel Aviv, Israel, Russell FM, Balloch A, Tang ML, Carapetis JR, Licciardi P, Nelson J, et al. Immunogenicity following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine. Vaccine Sep 18;27(41): Russell FM, Carapetis JR, Burton RL, Lin J, Licciardi PV, Balloch A, et al. Opsonophagocytic activity following a reduced dose 7-valent pneumococcal conjugate 5

Immunogenicity of a 2-Dose priming and booster vaccination with the 10-Valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine. The Pediatric Infectious Disease Journal.

6 vaccine infant primary series and 23-valent pneumococcal polysaccharide vaccine at 12 months of age. Vaccine Jan 10;29(3): Russell FM, Licciardi PV, Balloch A, Biaukula V, Tikoduadua L, Carapetis JR, et al. Safety and immunogenicity of the 23-valent pneumococcal polysaccharide vaccine at 12 months of age, following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine in infancy. Vaccine Apr 19;28(18): Russell FM, Carapetis JR, Balloch A, Licciardi PV, Jenney AW, Tikoduadua L, et al. Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial. Vaccine Apr 26;28(19): Ota MO, Akinsola A, Townend J, Antonio M, Enwere G, Nsekpong D, et al. The immunogenicity and impact on nasopharyngeal carriage of fewer doses of conjugate pneumococcal vaccine immunization schedule. Vaccine Apr 5;29(16): Goldblatt D, Akoto O, Ashton L, Asafo-Adje E, Brainsby K, Twumasi P, et al. Immunogenicity and the generation of immune memory following 9-valent conjugate vaccination in Ghanaian infants with sickle cell disease. Abstract no. 688, 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September, 17-20, Toronto, Canada, Sigurdardottir ST, Davidsdottir K, Arasonc V, A., Jonsdottir O, Laudate F, Gruberf WC, et al. Safety and immunogenicity of CRM197-conjugated pneumococcal meningococcal C combination vaccine (9vPnC MnCC) whether given in two or three primary doses. Vaccine. 2008; Sigurdardottir ST. Pneumococcal conjugate vaccines in Icelandic infants. [PhD Thesis]: University of Iceland; 2009; Available from: [accessed August 17, 2011]. 14. Givon-Lavi N, Greenberg D, Dagan R. Immunogenicity of Alternative Regimens of the Conjugated 7-Valent Pneumococcal Vaccine A Randomized Controlled Trial. Pediatric Infectious Disease Journal. 2010;29: Dagan R. Immunogenicity of CRM-Conjugated 7-Valent Pneumococcal Vaccine (PCV7) Administered at a Licensed 3-dose Primary Schedule (3 + 1) Compared to a Reduced 2- Dose Primary Schedule (2 + 1) - A Randomized Study. Abstract 189, 45 th Annual Meeting of the Infectious Disease Society of America, October 4-7, San Diego, USA, Dagan R, Givon-Lavi N, al. e. Nasopharangeal pneumococcal carriage (NPC) in the first year of life following the administration of 2 or 3 doses of 7-valent crm-conjugate vaccine. Abstract no. 189, The 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 17-20, Chicago, Illinois, USA, Givon-Lavi N, Greenberg D, Volcov T, Piglansky L, Dagan R, editors. Inferior immunogenicity after primary immunization with conjugated pneumococcal vaccine at 2 doses (4, 6m) versus 3 doses (2, 4, 6m). European Society for Paediatric Infectious Diseases (ESPID); May 2-4; Porto, Portugal, Givon-Lavi N, Greenberg D, Dagan R. Effect of a reduced dose infant schedule of the 7 - valent pneumococcal conjugate vaccine (PCV7) on nasopharyngeal pneumococcal 6

Safety and immunogenicity of the 23-valent pneumococcal polysaccharide vaccine at 12 months of age, following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine in infancy.

7 carriage (NP-PNC-CARR). Abstract 427, The 27th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), June 9-13, Brussels, Belgium, Givon-Lavi N, Greenberg D, Dagan R. PCV 7 serotype-specific protection against pneumococcal nasopharyngeal acquisition occurs through additional mechanisms not fully reflected by concentrations of circulating serotype-specific IgG. Abstract no. 243, 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), March 14-18, Tel Aviv, Israel, Dagan R, Givon-Lavi N, Greenberg D, Fritzell B, Siegrist CA. Nasopharyngeal carriage of Streptococcus pneumoniae shortly before vaccination with a pneumococcal conjugate vaccine causes serotype-specific hyporesponsiveness in early infancy. J Infect Dis May 15;201(10): Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, et al. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J Apr;25(4): Whitney CG, Pilishvili T, Farley MM, Schaffner W, Craig AS, Lynfield R, et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet Oct 28;368(9546):

PCV 7 serotype-specific protection against pneumococcal nasopharyngeal acquisition occurs through additional mechanisms not fully reflected by concentrations of circulating serotype-specific IgG.

Carol Lefebvre Senior Information Specialist UK Cochrane Centre National Institute for Health Research Oxford, UK

Clinical trials registers and clinical trials results registers: their contribution as health information sources to evidence-based healthcare decision-making Carol Lefebvre Senior Information Specialist