Immunogenicity and Safety of an Investigational Hexavalent Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and 6-month-old Argentinean Infants.

[Guest guest]

Pediatr Infect Dis J. 2011 Mar 2. [Epub ahead of print]

Immunogenicity and Safety of an Investigational Hexavalent

Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis

B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and

6-month-old Argentinean Infants.

Tregnaghi MW, Zambrano B, Santos-Lima E.

From the *Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina;

†Sanofi Pasteur, Montevideo, Uruguay; and ‡Sanofi Pasteur, Lyon, France.

Abstract

BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational

hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing

the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 μg Hansenula

polymorpha-derived recombinant hepatitis B (Hep surface antigen, Sanofi

Pasteur, in Argentinean infants.

METHODS: Infants born to Hep B surface antigen seronegative mothers were

randomized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B

Pediatrico (Hep B monovalent) vaccines at 2, 4, 6 months of age. Antibody titers

were measured before and 1 month after 3-month primary vaccination.

Noninferiority analyses were performed on seroprotection/seroconversion rates.

Safety was evaluated descriptively up to 1 month after primary vaccination.

RESULTS: A total of 624 participants were enrolled, 312 participants were

randomized to each group, and 604 participants completed the trial. The

DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and

Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month

postdose 3 for each valence. The anti-Hep B geometric mean titer 1-month

postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was

similar to the monovalent Hep B control. The overall incidence of adverse events

was similar among the 2 groups.

CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine

(Hexaxim) is highly immunogenic and safe when compared with licensed

comparators, warranting further development.

PMID: 21372751 [PubMed - as supplied by publisher]

[Guest guest]

Pediatr Infect Dis J. 2011 Mar 2. [Epub ahead of print]

Immunogenicity and Safety of an Investigational Hexavalent

Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis

B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and

6-month-old Argentinean Infants.

Tregnaghi MW, Zambrano B, Santos-Lima E.

From the *Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina;

†Sanofi Pasteur, Montevideo, Uruguay; and ‡Sanofi Pasteur, Lyon, France.

Abstract

BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational

hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing

the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 μg Hansenula

polymorpha-derived recombinant hepatitis B (Hep surface antigen, Sanofi

Pasteur, in Argentinean infants.

METHODS: Infants born to Hep B surface antigen seronegative mothers were

randomized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B

Pediatrico (Hep B monovalent) vaccines at 2, 4, 6 months of age. Antibody titers

were measured before and 1 month after 3-month primary vaccination.

Noninferiority analyses were performed on seroprotection/seroconversion rates.

Safety was evaluated descriptively up to 1 month after primary vaccination.

RESULTS: A total of 624 participants were enrolled, 312 participants were

randomized to each group, and 604 participants completed the trial. The

DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and

Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month

postdose 3 for each valence. The anti-Hep B geometric mean titer 1-month

postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was

similar to the monovalent Hep B control. The overall incidence of adverse events

was similar among the 2 groups.

CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine

(Hexaxim) is highly immunogenic and safe when compared with licensed

comparators, warranting further development.

PMID: 21372751 [PubMed - as supplied by publisher]

[Guest guest]

Pediatr Infect Dis J. 2011 Mar 2. [Epub ahead of print]

Immunogenicity and Safety of an Investigational Hexavalent

Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis

B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and

6-month-old Argentinean Infants.

Tregnaghi MW, Zambrano B, Santos-Lima E.

From the *Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina;

†Sanofi Pasteur, Montevideo, Uruguay; and ‡Sanofi Pasteur, Lyon, France.

Abstract

BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational

hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing

the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 μg Hansenula

polymorpha-derived recombinant hepatitis B (Hep surface antigen, Sanofi

Pasteur, in Argentinean infants.

METHODS: Infants born to Hep B surface antigen seronegative mothers were

randomized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B

Pediatrico (Hep B monovalent) vaccines at 2, 4, 6 months of age. Antibody titers

were measured before and 1 month after 3-month primary vaccination.

Noninferiority analyses were performed on seroprotection/seroconversion rates.

Safety was evaluated descriptively up to 1 month after primary vaccination.

RESULTS: A total of 624 participants were enrolled, 312 participants were

randomized to each group, and 604 participants completed the trial. The

DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and

Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month

postdose 3 for each valence. The anti-Hep B geometric mean titer 1-month

postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was

similar to the monovalent Hep B control. The overall incidence of adverse events

was similar among the 2 groups.

CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine

(Hexaxim) is highly immunogenic and safe when compared with licensed

comparators, warranting further development.

PMID: 21372751 [PubMed - as supplied by publisher]

[Guest guest]

Pediatr Infect Dis J. 2011 Mar 2. [Epub ahead of print]

Immunogenicity and Safety of an Investigational Hexavalent

Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis

B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and

6-month-old Argentinean Infants.

Tregnaghi MW, Zambrano B, Santos-Lima E.

From the *Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina;

†Sanofi Pasteur, Montevideo, Uruguay; and ‡Sanofi Pasteur, Lyon, France.

Abstract

BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational

hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing

the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 μg Hansenula

polymorpha-derived recombinant hepatitis B (Hep surface antigen, Sanofi

Pasteur, in Argentinean infants.

METHODS: Infants born to Hep B surface antigen seronegative mothers were

randomized to receive the DTaP-IPV-Hep B-PRP-T vaccine or Pentaxim and Engerix B

Pediatrico (Hep B monovalent) vaccines at 2, 4, 6 months of age. Antibody titers

were measured before and 1 month after 3-month primary vaccination.

Noninferiority analyses were performed on seroprotection/seroconversion rates.

Safety was evaluated descriptively up to 1 month after primary vaccination.

RESULTS: A total of 624 participants were enrolled, 312 participants were

randomized to each group, and 604 participants completed the trial. The

DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and

Hep B monovalent vaccines with seroprotection/seroconversion rates 1 month

postdose 3 for each valence. The anti-Hep B geometric mean titer 1-month

postdose 3 for the investigational DTaP-IPV-Hep B-PRP-T primary series was

similar to the monovalent Hep B control. The overall incidence of adverse events

was similar among the 2 groups.

CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine

(Hexaxim) is highly immunogenic and safe when compared with licensed

comparators, warranting further development.

PMID: 21372751 [PubMed - as supplied by publisher]