alexa Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru
ISSN: 2157-7560

Journal of Vaccines & Vaccination
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Article

Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru

Claudio Lanata1, Betzana Zambrano2, Lucie Ecker1, Isabel Amemiya1, Ana Gil1 and Eduardo Santos-Lima3*

1Instituto de Investigación Nutricional, Lima, Peru

2Sanofi Pasteur, Montevideo, Uruguay

3Sanofi Pasteur, Lyon, France

*Corresponding Author:
Dr. Eduardo Santos-Lima
Director, Clinical Development
Sanofi Pasteur, 1541 avenue, Marcel Mérieux
69280 Marcy l’Etoile, France
Tel: +33 (0) 4 37 37 58 53
Fax: + 33 (0) 4 37 37 78 88
E-mail: [email protected]

Received Date: January 10, 2012; Accepted Date: March 12, 2012; Published Date: March 18, 2012

Citation: Lanata C, Zambrano B, Ecker L, Amemiya I, Gil A, et al. (2012) Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru. J Vaccines Vaccin 3:128. doi: 10.4172/2157-7560.1000128

Copyright: © 2012 Lanata C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Objectives: To assess the immunogenicity and safety of a new candidate, fully liquid, hexavalent DTaP-IPVHep B-PRP-T vaccine (Hexaxim™, an AcXim family vaccine) compared to a licensed hexavalent DTaP-IPV-Hep B// PRP-T vaccine (Infanrix hexa®) in Peru. Methods: Infants born to HBsAg seronegative mothers and who had not received a hepatitis B vaccine prior to entry into the study were randomized to receive either Hexaxim™ (Group 1) or Infanrix hexa® (Group 2) at 2, 4, 6 months of age. Seroprotection (SP) rate for hepatitis B (anti-Hep B antibody concentration ≥10 mIU/mL) was analysed for non-inferiority (Group 1 minus Group 2) 1 month post-primary series. Anti-diphtheria and anti-polyribosyribitol phosphate (PRP) antibody responses were analysed descriptively. Safety was analysed from parental reports. Results: Seroprotection rate for anti-Hep B antibody titers ≥10 mIU/mL was high in both groups (≥99.2%) and non-inferiority was demonstrated (lower bound of the 95% CI for the difference was -4.17, above the pre-defined delta [-10%]). Post-primary SP rates for anti-diphtheria (≥95.5% ≥0.01 IU/mL), anti-PRP (≥99.2% ≥0.15 μg/mL), and anti-Hep B ≥100 mIU/mL (≥93.9%), were similar in each group. Both vaccines were well tolerated. The incidence of serious adverse avents was low and similar in each group, and none was considered to be vaccine related. Conclusions: In a 2, 4, 6 month schedule in Peruvian infants, the investigational DTaP-IPV-Hep B-PRP-T fully liquid vaccine provided high immunogenicity for Hep B, diphtheria and PRP vaccine antigens that was comparable to the licensed hexavalent vaccine. Both vaccines had a similar safety profile.


Share This Page

Additional Info

Loading Please wait..
Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals


[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version