Safety and Tolerability of 3 Lots of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given with Routine Vaccinations in the USA

Background:
13-valent pneumococcal conjugate vaccine (PCV13) includes 6 additional polysaccharide antigen serotypes to those included in the currently licensed Prevnar^® (PCV7). It was developed to give improved worldwide protection against vaccine-preventable invasive pneumococcal disease.

Objectives:
To compare the safety and immunogenicity of 2 pilot scale and 1 manufacturing scale (manu) lots of PCV13 in healthy infants when given with Pediarix^® and ActHIB conjugate vaccines in the USA. In addition, PCV7 was used as a comparator in the safety evaluation.

Methods:
Subjects 2 mo of age (N=1,698) were randomly assigned (2:2:2:1) to receive PCV13 pilot lot 1, PCV13 pilot lot 2, PCV13 manu lot, or PCV7 at 2, 4 and 6 mo of age. Blood was drawn at 7 mo for determination of pneumococcal anti-capsular polysaccharide serum IgG binding antibodies, and responses to tetanus, polio, and hepatitis B antigens. Local reactions, systemic events, and adverse events (AEs) were also recorded.

Results:
The pneumococcal IgG geometric mean concentrations were highly similar among the 3 vaccine lots and met the equivalence criteria for all 13 serotypes. Responses to tetanus, polio Types 1, 2, and 3, and hepatitis B in PCV13 and PCV7 recipients met equivalence criteria. Percentages of subjects reporting local reactions, systemic events, and use of antipyretic medications were comparable between PCV13 and PCV7 groups with no significant differences. Significant tenderness was reported in 7.4%–12.9% of subjects after doses 1, 2 and 3, and fever for 23.7%–27.8%, 28.0%–39.1%, and 28.8%–39.7% of subjects after doses 1, 2, and 3, respectively. Percentages of subjects reporting AEs were comparable between PCV13 and PCV7.

Conclusions:
A PCV13 manu vaccine lot and 2 PCV13 pilot lots showed acceptable and clinically consistent immunogenicity after administration at 2, 4, and 6 mo of age. The safety profile of PCV13 was acceptable and comparable to that of PCV7.