13-valent pneumococcal conjugate vaccine comparable to PCV7 in phase-3 trials
Acceptable safety profile observed among children concomitantly administered other routine childhood vaccines.
Data presented at the Advisory Committee on Immunization Practices meeting brings the investigational 13-valent pneumococcal conjugate vaccine one step closer to licensure. Public health officials are beginning to consider options for transitioning the vaccine into the current childhood immunization schedule once it receives FDA approval.
The 13-valent pneumococcal conjugate vaccine (PCV13, Wyeth) includes the seven serotypes already contained in PCV7 (Prevnar, Wyeth) plus an additional six strains (1, 3, 5, 6A, 7F and 19A).
The disease caused by the seven types that are included in PCV7 are very low now at 2% in children aged younger than 2 years and 4% in children between the ages of 2 and 4 after seven years of use in the United States, Peter R. Paradiso, PhD, vice president of scientific affairs at Wyeth Vaccines, said at the meeting.
Going by 2006 Active Core Bacterial Surveillance data, Paradiso projected that, once introduced, PCV13 will provide protection against about 64% of pneumococcal disease in children aged younger than 2 years and 73% in those aged 2 to 4 years.
In a German trial involving 604 healthy infants aged 2 months, antibody responses to the seven common serotypes were similar among the 301 infants who received PCV13 and the 303 infants who received PCV7; functional antibodies to the six additional serotypes were 10 to 100 times higher in the PCV13 group.
Geometric mean titers to serotype 19A, a strain associated with increasing rates of invasive pneumococcal disease, were 442 in children who received PCV13 compared with 6.7 in children who received PCV7.
In addition to PCV7 and PCV13, both trial groups also received combined diphtheria, tetanus and acellular pertussis (DTaP) vaccine, inactivated polio vaccine (IPV), Haemophilus influenzae type b conjugate vaccine (Hib), and hepatitis B surface antigen (HBsAg, Infanrix hexa, GlaxoSmithKline). No interference was observed between PCV13 and any of the concomitantly administered vaccines.
Currently, Wyeths new drug application for PCV13 has been granted FDA fast-track status, and Paradiso explained that submission of package insert material is underway and expected to be completed by the end of next month. by Nicole Blazek
For more information:
- Paradiso P. Pneumococcal vaccines: Update on PCV13 pediatric phase-3 trial results. Presented at: the ACIP meeting; Feb. 25-26, 2009; Atlanta.