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Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial

Record type: Article

Background: A 2-, 4-, and 12-month schedule of a novel 13-valent-pneumococcal conjugate vaccine (PCV13), containing serotype 1, 3, 4, 5, 6A, 6B 7F, 9V, 14, 18C, 19A, 19F, and 23F polysaccharides individually conjugated to CRM197 was evaluated in a randomized, double-blind, controlled infant study.

Methods: Two hundred eighty-six healthy infants received PCV13 or the 7-valent-pneumococcal conjugate vaccine (PCV7) at 2, 4, and 12 months of age, alongside a serogroup C meningococcal (MenC) vaccine (2 and 4 months of age), DTaP-IPV-Hib (2, 3, and 4 months), and a Hib-MenC vaccine (12 months). Specific antibody responses were assessed at age 5, 12, and 13 months.

Results: At 13 months of age, >97% of PCV13 recipients had pneumococcal serotype-specific serum IgG concentrations ?0.35 ?g/mL for each vaccine serotype except serotype 3 (88.2%), and at least 93% of PCV13 recipients had OPA titers ?1:8 for each serotype. At 5 months, 110/114 (96.5%) of PCV13 recipients and 100/102 (98.0%) of PCV7 recipients had serum anti-PRP (Hib) IgG concentration ?0.15 ?g/mL (difference, 1.5%; CI, ?7.1%–3.7%), while 119/120 (99.2%) and 117/118 (99.2%), respectively, had MenC serum bactericidal assay titers of ?1:8. All PCV13 recipients and 110/113 (97.3%) of PCV7 recipients had IgG concentrations against fimbrial agglutinogens of ?2.2 EU/mL; IgG concentrations for the remaining pertussis antigens were ?5 EU/mL for all participants. Local reactions and systemic events were similar in the PCV13 and PCV7 groups.

Conclusions: A 2-, 4-, and 12-month course of PCV13 was immunogenic for all 13 vaccine serotypes and was well tolerated.

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Citation

Snape, Matthew D., Klinger, Chaam L., Daniels, Elvis D., John, Tessa M., Layton, Helen, Rollinson, Llinos, Pestridge, Sarah, Dymond, Sandra, Galiza, Eva, Tansey, Susan, Scott, Daniel A., Baker, Sherryl A., Jones, Thomas R., Yu, Ly-Mee, Gruber, William C., Emini, Emilio A., Faust, Saul N., Finn, Adam, Heath, Paul T. and Pollard, Andrew J. (2010) Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial Pediatric Infectious Disease Journal, 29, (12), e80-90. (doi:10.1097/INF.0b013e3181faa6be). (PMID:21155091).

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Published date: December 2010

Identifiers

Local EPrints ID: 175579
URI: http://eprints.soton.ac.uk/id/eprint/175579
PURE UUID: a08cc861-eb8f-4f1c-a373-8fd0cef33187
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 24 Feb 2011 14:17
Last modified: 18 Jul 2017 12:09

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Contributors

Author: Matthew D. Snape
Author: Chaam L. Klinger
Author: Elvis D. Daniels
Author: Tessa M. John
Author: Helen Layton
Author: Llinos Rollinson
Author: Sarah Pestridge
Author: Sandra Dymond
Author: Eva Galiza
Author: Susan Tansey
Author: Daniel A. Scott
Author: Sherryl A. Baker
Author: Thomas R. Jones
Author: Ly-Mee Yu
Author: William C. Gruber
Author: Emilio A. Emini
Author: Saul N. Faust ORCID iD
Author: Adam Finn
Author: Paul T. Heath
Author: Andrew J. Pollard

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