The University of Southampton
University of Southampton Institutional Repository

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

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).

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.

Full text not available from this repository.

More information

Published date: December 2010


Local EPrints ID: 175579
PURE UUID: a08cc861-eb8f-4f1c-a373-8fd0cef33187
ORCID for Saul N. Faust: ORCID iD

Catalogue record

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

Export record



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

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton:

ePrints Soton supports OAI 2.0 with a base URL of

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.