PCV13 did not differ from PCV7 regarding safety, tolerability

Vanderkooi OT. Pediatr Infect Dis J. 2011;doi:10.1097/INF.0b013e318233049d.

Children who received either the 7-valent pneumococcal conjugate vaccine or the more broad-spectrum 13-valent pneumococcal conjugate vaccine formulation did not differ regarding their safety and tolerability profiles, according to a study published online this month.

Otto G. Vanderkooi, MD, of the department of pediatrics, University of Calgary and Alberta Health Services, and colleagues reported on results of a double blind, randomized study, in which 303 Canadian children received PCV7 (Prevnar, Wyeth) and 300 Canadian children received PCV13 (Prevnar13, Wyeth).

The researchers also assessed the children’s responses to Haemophilus influenzae type b, pertussis and meningococcal C conjugate vaccine, after these vaccines were administered around the same time of the pneumococcal vaccines. They found no statistically significant differences between the groups after either the primary or booster vaccinations.

“More than 95% of subjects in the PCV13 group produced 0.35 mcg/mL antibody to each pneumococcal serotype 1 month after the third dose, except with serotypes 23F (90%), 3 (80%), and 5 (87%),” the study researchers wrote. “After the fourth dose, 98% to 100% of subjects achieved serotype-specific antibody concentrations 0.35 mcg/mL, except for serotype 3 (85%).”

In addition, the researchers said, the number of children who achieved “predefined antibody response thresholds for concomitantly administered vaccines was not significantly different following the infant series. Similarly, antibody threshold levels for meningococcal C antigen following the toddler dose were achieved by all subjects in both groups. No evidence of interference between vaccines was seen in this trial of PCV13, similar to other studies with different concomitant childhood vaccines.”

Vanderkooi and colleagues said the additional serotypes contained within the PCV13 vaccine “have the potential to prevent a large burden of disease worldwide.”

Disclosure: The study was supported by Wyeth Pharmaceuticals, which also acted as study sponsor, prepared the study design and statistical analysis plan in collaboration with the non-industry authors and the Canadian PCV13 study group, and conducted the data analysis and pneumococcal laboratory assays. The manuscript was prepared by the non-industry authors with review by Pfizer.

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