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Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada.
Pediatr Infect Dis J. 2012 Jan; 31(1):72-7.PI

Abstract

BACKGROUND

The global distribution of pneumococcal disease and emergence of nonvaccine pneumococcal serotypes prompted the development of a 13-valent pneumococcal conjugate vaccine (PCV13), with broader coverage than 7-valent PCV (PCV7). This study compared compatibility of PCV13 and PCV7 with concurrently administered diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b vaccine, and meningococcal C conjugate vaccine (menC), and assessed the safety and immunogenicity of PCV13.

METHODS

In this double-blind, randomized trial, children received PCV7 or PCV13 at 2, 4, 6, and 12 months with routine vaccinations. One month following the infant series and toddler dose, the responses to Hib, pertussis, menC, and specific pneumococcal serotypes were measured. Safety and tolerability were assessed daily for 4 days by parents.

RESULTS

Subjects received PCV13 (n = 300) or PCV7 (n = 303); immunogenicity assessment was completed in 265 and 268 subjects, respectively. There were no statistically significant differences between the groups in responses to Hib, pertussis, or menC after primary or booster vaccinations. More than 95% of subjects in the PCV13 group produced >0.35 μg/mL antibody to each pneumococcal serotype 1 month after the third dose, except with serotypes 23F (90%), 3 (80%), and 5 (87%). After the fourth dose, 98% to 100% of subjects achieved serotype-specific antibody concentrations >0.35 μg/mL, except for serotype 3 (85%). Safety and tolerability did not differ between groups with respect to local or systemic side effects.

CONCLUSIONS

Responses to routine childhood vaccines did not differ with PCV7 or PCV13 coadministration. Serotype-specific pneumococcal antibody concentrations were protective. The safety profile of PCV13 was favorable.

Authors+Show Affiliations

Department of Pediatrics, University of Calgary & Alberta Health Services - Calgary Zone, Calgary, Alberta.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21960186

Citation

Vanderkooi, Otto G., et al. "Safety and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers Given With Routine Pediatric Vaccinations in Canada." The Pediatric Infectious Disease Journal, vol. 31, no. 1, 2012, pp. 72-7.
Vanderkooi OG, Scheifele DW, Girgenti D, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. Pediatr Infect Dis J. 2012;31(1):72-7.
Vanderkooi, O. G., Scheifele, D. W., Girgenti, D., Halperin, S. A., Patterson, S. D., Gruber, W. C., Emini, E. A., Scott, D. A., & Kellner, J. D. (2012). Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. The Pediatric Infectious Disease Journal, 31(1), 72-7. https://doi.org/10.1097/INF.0b013e318233049d
Vanderkooi OG, et al. Safety and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers Given With Routine Pediatric Vaccinations in Canada. Pediatr Infect Dis J. 2012;31(1):72-7. PubMed PMID: 21960186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine pediatric vaccinations in Canada. AU - Vanderkooi,Otto G, AU - Scheifele,David W, AU - Girgenti,Douglas, AU - Halperin,Scott A, AU - Patterson,Scott D, AU - Gruber,William C, AU - Emini,Emilio A, AU - Scott,Daniel A, AU - Kellner,James D, AU - ,, PY - 2011/10/1/entrez PY - 2011/10/1/pubmed PY - 2012/5/4/medline SP - 72 EP - 7 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 1 N2 - BACKGROUND: The global distribution of pneumococcal disease and emergence of nonvaccine pneumococcal serotypes prompted the development of a 13-valent pneumococcal conjugate vaccine (PCV13), with broader coverage than 7-valent PCV (PCV7). This study compared compatibility of PCV13 and PCV7 with concurrently administered diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b vaccine, and meningococcal C conjugate vaccine (menC), and assessed the safety and immunogenicity of PCV13. METHODS: In this double-blind, randomized trial, children received PCV7 or PCV13 at 2, 4, 6, and 12 months with routine vaccinations. One month following the infant series and toddler dose, the responses to Hib, pertussis, menC, and specific pneumococcal serotypes were measured. Safety and tolerability were assessed daily for 4 days by parents. RESULTS: Subjects received PCV13 (n = 300) or PCV7 (n = 303); immunogenicity assessment was completed in 265 and 268 subjects, respectively. There were no statistically significant differences between the groups in responses to Hib, pertussis, or menC after primary or booster vaccinations. More than 95% of subjects in the PCV13 group produced >0.35 μg/mL antibody to each pneumococcal serotype 1 month after the third dose, except with serotypes 23F (90%), 3 (80%), and 5 (87%). After the fourth dose, 98% to 100% of subjects achieved serotype-specific antibody concentrations >0.35 μg/mL, except for serotype 3 (85%). Safety and tolerability did not differ between groups with respect to local or systemic side effects. CONCLUSIONS: Responses to routine childhood vaccines did not differ with PCV7 or PCV13 coadministration. Serotype-specific pneumococcal antibody concentrations were protective. The safety profile of PCV13 was favorable. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/21960186/Safety_and_immunogenicity_of_a_13_valent_pneumococcal_conjugate_vaccine_in_healthy_infants_and_toddlers_given_with_routine_pediatric_vaccinations_in_Canada_ L2 - https://doi.org/10.1097/INF.0b013e318233049d DB - PRIME DP - Unbound Medicine ER -