Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial
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{"title"=>"Efficacy of Pneumococcal Nontypable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial", "type"=>"journal", "authors"=>[{"first_name"=>"Miguel W.", "last_name"=>"Tregnaghi", "scopus_author_id"=>"6603099599"}, {"first_name"=>"Xavier", "last_name"=>"Sáez-Llorens", "scopus_author_id"=>"7003732236"}, {"first_name"=>"Pio", "last_name"=>"López", "scopus_author_id"=>"23989138000"}, {"first_name"=>"Hector", "last_name"=>"Abate", "scopus_author_id"=>"23988756800"}, {"first_name"=>"Enrique", "last_name"=>"Smith", "scopus_author_id"=>"56230186000"}, {"first_name"=>"Adriana", "last_name"=>"Pósleman", "scopus_author_id"=>"56229390200"}, {"first_name"=>"Arlene", "last_name"=>"Calvo", "scopus_author_id"=>"56229817200"}, {"first_name"=>"Digna", "last_name"=>"Wong", "scopus_author_id"=>"56229826000"}, {"first_name"=>"Carlos", "last_name"=>"Cortes-Barbosa", "scopus_author_id"=>"37072153500"}, {"first_name"=>"Ana", "last_name"=>"Ceballos", "scopus_author_id"=>"57198172794"}, {"first_name"=>"Marcelo", "last_name"=>"Tregnaghi", "scopus_author_id"=>"55391474800"}, {"first_name"=>"Alexandra", "last_name"=>"Sierra", "scopus_author_id"=>"36814559700"}, {"first_name"=>"Mirna", "last_name"=>"Rodriguez", "scopus_author_id"=>"56230265200"}, {"first_name"=>"Marisol", "last_name"=>"Troitiño", "scopus_author_id"=>"56229522300"}, {"first_name"=>"Carlos", "last_name"=>"Carabajal", "scopus_author_id"=>"56230163100"}, {"first_name"=>"Andrea", "last_name"=>"Falaschi", "scopus_author_id"=>"42061297700"}, {"first_name"=>"Ana", "last_name"=>"Leandro", "scopus_author_id"=>"57078878200"}, {"first_name"=>"Maria Mercedes", "last_name"=>"Castrejón", "scopus_author_id"=>"6506330861"}, {"first_name"=>"Alejandro", "last_name"=>"Lepetic", "scopus_author_id"=>"6508252446"}, {"first_name"=>"Patricia", "last_name"=>"Lommel", "scopus_author_id"=>"12762384200"}, {"first_name"=>"William P.", "last_name"=>"Hausdorff", "scopus_author_id"=>"35290727800"}, {"first_name"=>"Dorota", "last_name"=>"Borys", "scopus_author_id"=>"26535533900"}, {"first_name"=>"Javier Ruiz", "last_name"=>"Guiñazú", "scopus_author_id"=>"56230140100"}, {"first_name"=>"Eduardo", "last_name"=>"Ortega-Barría", "scopus_author_id"=>"6701681386"}, {"first_name"=>"Juan P.", "last_name"=>"Yarzábal", "scopus_author_id"=>"8963289400"}, {"first_name"=>"Lode", "last_name"=>"Schuerman", "scopus_author_id"=>"6603003821"}], "year"=>2014, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491676", "scopus"=>"2-s2.0-84903304920", "pui"=>"373397985", "doi"=>"10.1371/journal.pmed.1001657", "isbn"=>"1549-1277", "sgr"=>"84903304920", "pmid"=>"24892763"}, "id"=>"249577d9-b93b-373e-bc23-28746603e2a7", "abstract"=>"BACKGROUND: The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.\\n\\nMETHODS AND FINDINGS: This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.\\n\\nCONCLUSIONS: Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.\\n\\nTRIAL REGISTRATION: www.ClinicalTrials.gov NCT00466947.", "link"=>"http://www.mendeley.com/research/efficacy-pneumococcal-nontypable-haemophilus-influenzae-protein-d-conjugate-vaccine-phidcv-young-lat", "reader_count"=>81, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>23, "Student > Doctoral Student"=>4, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>3, "Other"=>8, "Student > Master"=>16, "Student > Bachelor"=>8, "Lecturer"=>2, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>23, "Student > Doctoral Student"=>4, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>3, "Other"=>8, "Student > Master"=>16, "Student > Bachelor"=>8, "Lecturer"=>2, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Nursing and Health Professions"=>4, "Biochemistry, Genetics and Molecular Biology"=>2, "Mathematics"=>1, "Agricultural and Biological Sciences"=>6, "Medicine and Dentistry"=>53, "Business, Management and Accounting"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Psychology"=>2, "Computer Science"=>1, "Immunology and Microbiology"=>4, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>53}, "Psychology"=>{"Psychology"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>4}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>4}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Brazil"=>1, "United Kingdom"=>2, "Slovakia"=>1, "Kenya"=>1}, "group_count"=>7}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1519727"], "description"=>"<p>A full listing of SAEs is provided in <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001657#pmed.1001657.s011\" target=\"_blank\">Table S8</a>.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "adverse", "children"], "article_id"=>1045056, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t006", "stats"=>{"downloads"=>7, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Serious_adverse_events_reported_from_study_start_and_administration_of_the_first_vaccine_dose_up_to_study_end_in_at_least_1_0_of_children_intent_to_treat_cohort_all_children_/1045056", "title"=>"Serious adverse events reported from study start and administration of the first vaccine dose up to study end in at least 1.0% of children (intent-to-treat cohort: all children).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519725"], "description"=>"a<p>59% of participants were recruited in Argentina (race predominantly white or with European heritage), and the remaining were recruited in Colombia and Panama (participants predominantly mixed race).</p>b<p>Follow-up time calculated as sum of follow-up periods of each child, expressed in years, censored at the first occurrence of a respective end point event.</p>c<p>Recruited in Panama only.</p><p>SD, standard deviation.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "included", "efficacy", "interim", "ipd", "end-of-study", "aom"], "article_id"=>1045054, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t003", "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_the_trial_participants_included_in_the_analysis_of_the_primary_study_end_point_CAP_efficacy_cohort_interim_analysis_CAP_and_IPD_end_of_study_analysis_CAP_IPD_efficacy_cohort_and_AOM_end_of_study_analysis_AOM_efficacy_cohort_/1045054", "title"=>"Characteristics of the trial participants included in the analysis of the primary study end point (CAP efficacy cohort; interim analysis), CAP and IPD end-of-study analysis (CAP/IPD efficacy cohort), and AOM end-of-study analysis (AOM efficacy cohort).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519722"], "description"=>"<p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "children", "included"], "article_id"=>1045051, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.g003", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_for_children_included_in_the_analysis_of_the_primary_study_end_point_/1045051", "title"=>"Trial profile for children included in the analysis of the primary study end point.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519721"], "description"=>"<p>Chest X-ray classification and CAP end point definitions.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "x-ray", "classification"], "article_id"=>1045050, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.g002", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Chest_X_ray_classification_and_CAP_end_point_definitions_/1045050", "title"=>"Chest X-ray classification and CAP end point definitions.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519729"], "description"=>"<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode.</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Pneumococcal serotype 6A, 18B, 19A, or 23A.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "phid-cv", "acute", "otitis", "episodes"], "article_id"=>1045058, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t005", "stats"=>{"downloads"=>7, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Efficacy_of_PHiD_CV_against_first_acute_otitis_media_episodes_end_of_study_analysis_/1045058", "title"=>"Efficacy of PHiD-CV against first acute otitis media episodes (end-of-study analysis).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519724"], "description"=>"<p>Inclusion and exclusion criteria.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "exclusion"], "article_id"=>1045053, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t002", "stats"=>{"downloads"=>11, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Inclusion_and_exclusion_criteria_/1045053", "title"=>"Inclusion and exclusion criteria.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519723"], "description"=>"<p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "children", "included", "end-of-study", "acute", "otitis"], "article_id"=>1045052, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.g004", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_profile_for_children_included_in_the_end_of_study_analysis_of_acute_otitis_media_/1045052", "title"=>"Trial profile for children included in the end-of-study analysis of acute otitis media.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519720"], "description"=>"<p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertussis–hepatitis B–inactivated poliovirus–<i>Haemophilus influenzae</i> type b vaccine (DTPa-HBV-IPV/Hib), Infanrix hexa; DTPa-IPV/Hib, Infanrix-IPV/Hib; hepatitis B, Engerix-B; hepatitis A, Havrix (all by GlaxoSmithKline Vaccines). In addition to these blinded study vaccines, the following vaccines were administered or were recommended: measles–mumps–rubella vaccine at 12 mo of age, hepatitis B vaccination at birth, and hepatitis A vaccination at 12 and 18–21 mo of age, with the second dose given at least 28 days after the study vaccine booster dose. In Argentina, <i>Neisseria meningitidis</i> group C conjugate vaccine (NeisVac-C, Baxter International) was offered at 12 mo of age; in Colombia and Panama, varicella vaccine (Varilrix, GlaxoSmithKline Vaccines) was offered at 12 mo of age; in Colombia, two doses of oral rotavirus vaccine (Rotarix, GlaxoSmithKline Vaccines) were offered within the first 6 mo of life.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies"], "article_id"=>1045049, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.g001", "stats"=>{"downloads"=>0, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Vaccination_schedule_/1045049", "title"=>"Vaccination schedule.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519731", "https://ndownloader.figshare.com/files/1519732", "https://ndownloader.figshare.com/files/1519733", "https://ndownloader.figshare.com/files/1519734", "https://ndownloader.figshare.com/files/1519735", "https://ndownloader.figshare.com/files/1519736", "https://ndownloader.figshare.com/files/1519737", "https://ndownloader.figshare.com/files/1519738", "https://ndownloader.figshare.com/files/1519739", "https://ndownloader.figshare.com/files/1519740", "https://ndownloader.figshare.com/files/1519741", "https://ndownloader.figshare.com/files/1519742", "https://ndownloader.figshare.com/files/1519743", "https://ndownloader.figshare.com/files/1519744", "https://ndownloader.figshare.com/files/1519745", "https://ndownloader.figshare.com/files/1519746"], "description"=>"<div><p>Background</p><p>The relationship between pneumococcal conjugate vaccine–induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable <i>Haemophilus influenzae</i> protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed.</p><p>Methods and Findings</p><p>This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15–18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, <i>n</i> = 10,295; control, <i>n</i> = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided <i>p</i> = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization–defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28–30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, <i>n</i> = 10,211; control, <i>n</i> = 10,140) and AOM (<i>n</i> = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: −1.1%, 30.4%; one-sided <i>p</i> = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (<i>n</i> = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (<i>n</i> = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases.</p><p>Conclusions</p><p>Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice.</p><p>Trial registration</p><p><a href=\"http://www.ClinicalTrials.gov\" target=\"_blank\">www.ClinicalTrials.gov</a><a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00466947\" target=\"_blank\">NCT00466947</a></p><p><i>Please see later in the article for the Editors' Summary</i></p></div>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "efficacy", "pneumococcal", "nontypable", "conjugate", "latin", "american", "double-blind", "randomized", "controlled"], "article_id"=>1045060, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001657.s001", "https://dx.doi.org/10.1371/journal.pmed.1001657.s002", "https://dx.doi.org/10.1371/journal.pmed.1001657.s003", "https://dx.doi.org/10.1371/journal.pmed.1001657.s004", "https://dx.doi.org/10.1371/journal.pmed.1001657.s005", "https://dx.doi.org/10.1371/journal.pmed.1001657.s006", "https://dx.doi.org/10.1371/journal.pmed.1001657.s007", "https://dx.doi.org/10.1371/journal.pmed.1001657.s008", "https://dx.doi.org/10.1371/journal.pmed.1001657.s009", "https://dx.doi.org/10.1371/journal.pmed.1001657.s010", "https://dx.doi.org/10.1371/journal.pmed.1001657.s011", "https://dx.doi.org/10.1371/journal.pmed.1001657.s012", "https://dx.doi.org/10.1371/journal.pmed.1001657.s013", "https://dx.doi.org/10.1371/journal.pmed.1001657.s014", "https://dx.doi.org/10.1371/journal.pmed.1001657.s015", "https://dx.doi.org/10.1371/journal.pmed.1001657.s016"], "stats"=>{"downloads"=>78, "page_views"=>17, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Efficacy_of_Pneumococcal_Nontypable_Haemophilus_influenzae_Protein_D_Conjugate_Vaccine_PHiD_CV_in_Young_Latin_American_Children_A_Double_Blind_Randomized_Controlled_Trial/1045060", "title"=>"Efficacy of Pneumococcal Nontypable <i>Haemophilus influenzae</i> Protein D Conjugate Vaccine (PHiD-CV) in Young Latin American Children: A Double-Blind Randomized Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519728"], "description"=>"<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode when at least one event was observed in each group and conditional on number of cases when no case in at least one group (i.e., VE equal to zero or −infinite (VE, 1 − [<i>x</i>/0]).</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Significant <i>p</i>-value (<i>p</i> = 0.002); one-sided <i>p</i>-value from Cox regression model to test null hypothesis VE ≤ 0% with one-sided alpha of 1.75%.</p>c<p><i>S. pneumoniae</i> was isolated from all culture-confirmed invasive disease cases.</p>d<p>Pneumococcal serotype 6A, 9N, or 19A.</p><p>NC, not calculable.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies", "phid-cv", "community-acquired", "pneumonia", "invasive", "pneumococcal"], "article_id"=>1045057, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t004", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Efficacy_of_PHiD_CV_against_first_community_acquired_pneumonia_and_invasive_pneumococcal_disease_episodes_/1045057", "title"=>"Efficacy of PHiD-CV against first community-acquired pneumonia and invasive pneumococcal disease episodes.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/1519726"], "description"=>"<p>AOM, acute otitis media; B-CAP, likely bacterial community-acquired pneumonia; C-AOM, clinically confirmed acute otitis media; CAP, community-acquired pneumonia; CRP, C-reactive protein; IPD, invasive pneumococcal disease; PHiD-CV, pneumococcal nontypable <i>Haemophilus influenzae</i> protein D conjugate vaccine; SAE, serious adverse event; VT, vaccine serotype.</p>", "links"=>[], "tags"=>["immunology", "Vaccination and immunization", "Clinical medicine", "clinical trials", "Phase III clinical investigation", "Infectious diseases", "Bacterial diseases", "Streptococcal infections", "pediatrics", "Public and occupational health", "research design", "Clinical research design", "Cohort studies"], "article_id"=>1045055, "categories"=>["Biological Sciences"], "users"=>["Miguel W. Tregnaghi", "Xavier Sáez-Llorens", "Pio López", "Hector Abate", "Enrique Smith", "Adriana Pósleman", "Arlene Calvo", "Digna Wong", "Carlos Cortes-Barbosa", "Ana Ceballos", "Marcelo Tregnaghi", "Alexandra Sierra", "Mirna Rodriguez", "Marisol Troitiño", "Carlos Carabajal", "Andrea Falaschi", "Ana Leandro", "Maria Mercedes Castrejón", "Alejandro Lepetic", "Patricia Lommel", "William P. Hausdorff", "Dorota Borys", "Javier Ruiz Guiñazú", "Eduardo Ortega-Barría", "Juan P. Yarzábal", "Lode Schuerman"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.1001657.t001", "stats"=>{"downloads"=>4, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Study_objectives_/1045055", "title"=>"Study objectives.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-03 04:14:14"}

PMC Usage Stats | Further Information

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Relative Metric

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