Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial
Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial...
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| creator | Pomat, William S van den Biggelaar, Anita H J Phuanukoonnon, Suparat Francis, Jacinta Jacoby, Peter Siba, Peter M Alpers, Michael P Reeder, John C Holt, Patrick G Richmond, Peter C Lehmann, Deborah |
| description | Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.
We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.
We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p |
| doi_str_mv | 10.1371/journal.pone.0056698 |
| format | Article |
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We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.
We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.
PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.
ClinicalTrials.gov NCT00219401.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0056698</identifier><identifier>PMID: 23451070</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Age ; Background levels ; Baseline studies ; Birth ; Children ; Children & youth ; Childrens health ; Clinical trials ; Disease ; Female ; Humans ; Immunization Schedule ; Immunogenicity ; Immunoglobulin G ; Immunoglobulin G - blood ; Immunology ; Infant ; Infant, Newborn ; Infants ; Male ; Medical research ; Medicine ; Meningitis ; Mortality ; Neonates ; Newborn babies ; Newborn infants ; Pneumococcal Infections - immunology ; Pneumococcal Infections - prevention & control ; Pneumococcal Vaccines - adverse effects ; Pneumococcal Vaccines - therapeutic use ; Pneumonia ; Polysaccharides ; Priming ; Randomization ; Safety ; Serotypes ; Streptococcus infections ; Vaccination ; Vaccines ; Vaccines, Conjugate - adverse effects ; Vaccines, Conjugate - therapeutic use</subject><ispartof>PloS one, 2013-02, Vol.8 (2), p.e56698</ispartof><rights>COPYRIGHT 2013 Public Library of Science</rights><rights>2013 Pomat et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 Pomat et al 2013 Pomat et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-fcc1e33f08855f1d7fc981e5b8aace800c08f64d3f68256b91204b1f7151d60d3</citedby><cites>FETCH-LOGICAL-c692t-fcc1e33f08855f1d7fc981e5b8aace800c08f64d3f68256b91204b1f7151d60d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579820/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3579820/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23451070$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pomat, William S</creatorcontrib><creatorcontrib>van den Biggelaar, Anita H J</creatorcontrib><creatorcontrib>Phuanukoonnon, Suparat</creatorcontrib><creatorcontrib>Francis, Jacinta</creatorcontrib><creatorcontrib>Jacoby, Peter</creatorcontrib><creatorcontrib>Siba, Peter M</creatorcontrib><creatorcontrib>Alpers, Michael P</creatorcontrib><creatorcontrib>Reeder, John C</creatorcontrib><creatorcontrib>Holt, Patrick G</creatorcontrib><creatorcontrib>Richmond, Peter C</creatorcontrib><creatorcontrib>Lehmann, Deborah</creatorcontrib><creatorcontrib>Neonatal Pneumococcal Conjugate Vaccine Trial Study Team</creatorcontrib><creatorcontrib>for the Neonatal Pneumococcal Conjugate Vaccine Trial Study Team</creatorcontrib><title>Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.
We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.
We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.
PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.
ClinicalTrials.gov NCT00219401.</description><subject>Age</subject><subject>Background levels</subject><subject>Baseline studies</subject><subject>Birth</subject><subject>Children</subject><subject>Children & youth</subject><subject>Childrens health</subject><subject>Clinical trials</subject><subject>Disease</subject><subject>Female</subject><subject>Humans</subject><subject>Immunization Schedule</subject><subject>Immunogenicity</subject><subject>Immunoglobulin G</subject><subject>Immunoglobulin G - blood</subject><subject>Immunology</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infants</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Meningitis</subject><subject>Mortality</subject><subject>Neonates</subject><subject>Newborn babies</subject><subject>Newborn infants</subject><subject>Pneumococcal Infections - immunology</subject><subject>Pneumococcal Infections - prevention & control</subject><subject>Pneumococcal Vaccines - adverse effects</subject><subject>Pneumococcal Vaccines - therapeutic use</subject><subject>Pneumonia</subject><subject>Polysaccharides</subject><subject>Priming</subject><subject>Randomization</subject><subject>Safety</subject><subject>Serotypes</subject><subject>Streptococcus infections</subject><subject>Vaccination</subject><subject>Vaccines</subject><subject>Vaccines, Conjugate - adverse effects</subject><subject>Vaccines, Conjugate - therapeutic use</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNk9GK1DAUhoso7jr6BqIBQfBixqRp09QLYVl0HVhccdXbcJomnQxpMibt6j6A723qdJcdUJAWmp5850_yn5wse0rwitCKvN76MTiwq513aoVxyVjN72XHpKb5kuWY3r8zPsoexbhNEOWMPcyOclqUBFf4OPt1CVoN1whci0zfj853yhlpUshr5JR3MIBFO6fG3ksvZfqR3m3HDgaFrkBKkwjjHTIOfYLdCOij-oHORuMUOCQ3xrZBuTcIUEhr-N5E1U4KQ_DWpuEQDNjH2QMNNqon83eRfX3_7svph-X5xdn69OR8KVmdD0stJVGUasx5WWrSVlrWnKiy4QBScYwl5poVLdWM5yVrapLjoiG6IiVpGW7pInu-191ZH8XsYBSElumtOKGJWO-J1sNW7ILpIVwLD0b8CfjQCQiDkVYJWiZrGYG84bJQZQFtXWBJmQasG9k0SevtvNrY9KqVKh0a7IHo4YwzG9H5q6Rc1TyVbZG9mAWC_z6qOPxjyzPVQdqVcdonMZmMluKkSASrCJu0Vn-h0tOq3qR6KG1S_CDh1UHCVDP1c-hgjFGsLz__P3vx7ZB9eYfdKLDDJno7TpcoHoLFHpTBxxiUvnWOYDG1wI0bYmoBMbdASnt21_XbpJs7T38DW44D1g</recordid><startdate>20130222</startdate><enddate>20130222</enddate><creator>Pomat, William S</creator><creator>van den Biggelaar, Anita H J</creator><creator>Phuanukoonnon, Suparat</creator><creator>Francis, Jacinta</creator><creator>Jacoby, Peter</creator><creator>Siba, Peter M</creator><creator>Alpers, Michael P</creator><creator>Reeder, John C</creator><creator>Holt, Patrick G</creator><creator>Richmond, Peter C</creator><creator>Lehmann, Deborah</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20130222</creationdate><title>Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial</title><author>Pomat, William S ; van den Biggelaar, Anita H J ; Phuanukoonnon, Suparat ; Francis, Jacinta ; Jacoby, Peter ; Siba, Peter M ; Alpers, Michael P ; Reeder, John C ; Holt, Patrick G ; Richmond, Peter C ; Lehmann, Deborah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-fcc1e33f08855f1d7fc981e5b8aace800c08f64d3f68256b91204b1f7151d60d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Age</topic><topic>Background levels</topic><topic>Baseline studies</topic><topic>Birth</topic><topic>Children</topic><topic>Children & youth</topic><topic>Childrens health</topic><topic>Clinical trials</topic><topic>Disease</topic><topic>Female</topic><topic>Humans</topic><topic>Immunization Schedule</topic><topic>Immunogenicity</topic><topic>Immunoglobulin G</topic><topic>Immunoglobulin G - blood</topic><topic>Immunology</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Infants</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Meningitis</topic><topic>Mortality</topic><topic>Neonates</topic><topic>Newborn babies</topic><topic>Newborn infants</topic><topic>Pneumococcal Infections - immunology</topic><topic>Pneumococcal Infections - prevention & control</topic><topic>Pneumococcal Vaccines - adverse effects</topic><topic>Pneumococcal Vaccines - therapeutic use</topic><topic>Pneumonia</topic><topic>Polysaccharides</topic><topic>Priming</topic><topic>Randomization</topic><topic>Safety</topic><topic>Serotypes</topic><topic>Streptococcus infections</topic><topic>Vaccination</topic><topic>Vaccines</topic><topic>Vaccines, Conjugate - adverse effects</topic><topic>Vaccines, Conjugate - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pomat, William S</creatorcontrib><creatorcontrib>van den Biggelaar, Anita H J</creatorcontrib><creatorcontrib>Phuanukoonnon, Suparat</creatorcontrib><creatorcontrib>Francis, Jacinta</creatorcontrib><creatorcontrib>Jacoby, Peter</creatorcontrib><creatorcontrib>Siba, Peter M</creatorcontrib><creatorcontrib>Alpers, Michael P</creatorcontrib><creatorcontrib>Reeder, John C</creatorcontrib><creatorcontrib>Holt, Patrick G</creatorcontrib><creatorcontrib>Richmond, Peter C</creatorcontrib><creatorcontrib>Lehmann, Deborah</creatorcontrib><creatorcontrib>Neonatal Pneumococcal Conjugate Vaccine Trial Study Team</creatorcontrib><creatorcontrib>for the Neonatal Pneumococcal Conjugate Vaccine Trial Study Team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.
We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.
We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.
PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.
ClinicalTrials.gov NCT00219401.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23451070</pmid><doi>10.1371/journal.pone.0056698</doi><tpages>e56698</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2013-02, Vol.8 (2), p.e56698 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1351357813 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Age Background levels Baseline studies Birth Children Children & youth Childrens health Clinical trials Disease Female Humans Immunization Schedule Immunogenicity Immunoglobulin G Immunoglobulin G - blood Immunology Infant Infant, Newborn Infants Male Medical research Medicine Meningitis Mortality Neonates Newborn babies Newborn infants Pneumococcal Infections - immunology Pneumococcal Infections - prevention & control Pneumococcal Vaccines - adverse effects Pneumococcal Vaccines - therapeutic use Pneumonia Polysaccharides Priming Randomization Safety Serotypes Streptococcus infections Vaccination Vaccines Vaccines, Conjugate - adverse effects Vaccines, Conjugate - therapeutic use |
| title | Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial |
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