Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines.

Abstract

BACKGROUND:

Licensed pneumococcal conjugate vaccine (7vCRM) is usually coadministered with combination vaccines in pediatric immunization programs. Reactogenicity and safety after primary and booster vaccination with a novel 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in comparison with 7vCRM, both coadministered with commonly used pediatric vaccines, was evaluated in 5 clinical studies.

METHODS:

Five randomized, controlled studies in which PHiD-CV or licensed 7vCRM vaccines coadministered with various DTPa-based combination vaccines, Neisseria meningitidis serogroup C conjugate vaccines and DTPw-HBV/Hib were conducted. Local and general symptoms were solicited for 4 days after each vaccine dose, using diary cards. All adverse events were recorded for 31 days after each dose and serious adverse events throughout the entire study periods.

RESULTS:

A total of 4004 subjects contributed to the safety data analyzed in this review. Fever >or=38.0 degrees C (rectal temperature) was reported after about one-third of primary or booster vaccine doses coadministered with DTPa-based vaccines and after approximately 60% of primary doses with DTPw coadministration in both PHiD-CV and 7vCRM groups. Fever >40.0 degrees C was reported after <or=1.1% of PHiD-CV doses and <or=2.2% of 7vCRM doses. The incidences and intensity of general reactions were generally within the same ranges in the PHiD-CV and 7vCRM groups. Drowsiness and irritability in the study with MenC-conjugates coadministration and irritability and loss of appetite in the study with DTPw-combined vaccines coadministration tended to be slightly higher in PHiD-CV groups. No such trend was observed for solicited general symptoms with grade 3 intensity.

CONCLUSIONS:

The safety and reactogenicity profiles of PHiD-CV and 7vCRM were within the same range when administered for primary and booster vaccination in coadministration with other routinely used pediatric vaccines.

• Authors: Bertrand Chevallier, Timo Vesikari, Jerzy Brzostek, Markus Knuf, Nancy Bermal, Javier Aristegui, Dorota Borys, Jan Cleerbout, Patricia Lommel, Lode Schuerman
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 28 Issue 4 Suppl Pg. S109-18 (Apr 2009) ISSN: 0891-3668 [Print] United States
• PMID: 19325447 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Bacterial Proteins
• Carrier Proteins
• DTPa-HBV-IPV combined vaccine
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Vaccines
• Heptavalent Pneumococcal Conjugate Vaccine
• Immunoglobulin D
• Lipoproteins
• Meningococcal Vaccines
• Pneumococcal Vaccines
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined
• Vaccines, Conjugate
• glpQ protein, Haemophilus influenzae

Topics

• Bacterial Proteins (immunology)
• Carrier Proteins (immunology)
• Diphtheria-Tetanus-Pertussis Vaccine
• Female
• Haemophilus Vaccines
• Hepatitis B Vaccines
• Heptavalent Pneumococcal Conjugate Vaccine
• Humans
• Immunization Programs
• Immunization Schedule
• Immunization, Secondary
• Immunoglobulin D (immunology)
• Infant
• Lipoproteins (immunology)
• Male
• Meningococcal Vaccines (administration & dosage, adverse effects)
• Neisseria meningitidis, Serogroup C
• Pneumococcal Vaccines (administration & dosage, adverse effects)
• Poliovirus Vaccine, Inactivated
• Randomized Controlled Trials as Topic
• Treatment Outcome
• Vaccination
• Vaccines, Combined (administration & dosage, adverse effects)
• Vaccines, Conjugate (administration & dosage, adverse effects)