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13-valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety.
Pediatr Infect Dis J. 2012 Apr; 31(4):392-9.PI

Abstract

BACKGROUND

As multiple vaccines are administered concomitantly during routine pediatric immunizations, it is important to ascertain the potential interference of any new vaccine on the immune response to the concomitantly administered vaccines. Immune responses to meningococcal serogroup C-tetanus toxoid conjugate vaccine (MnCC-TT) and the diphtheria and tetanus antigens in routine pediatric vaccines (diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenza type b [DTaP-HBV-IPV/Hib] and DTaP-IPV+Hib) when given concomitantly with the 13-valent pneumococcal conjugate vaccine (PCV13) were compared with responses when given with PCV7. In addition, the immunogenicity and safety of PCV13 were assessed.

METHODS

Healthy infants were randomized to receive PCV13 or PCV7 (ages 2, 4, 6 and 15 months), concomitant with MnCC-TT (2, 4 and 15 months), DTaP-HBV-IPV/Hib (2, 4 and 6 months), and DTaP-IPV+Hib (15 months).

RESULTS

Immune responses to MnCC-TT and to the diphtheria and tetanus antigens administered with PCV13 were noninferior to the responses observed when the vaccines were administered with PCV7; ≥96.6 (postinfant) and ≥99.4% (posttoddler) subjects achieved prespecified immune response levels to each antigen in each group. After the infant series, ≥93.0% of subjects receiving PCV13 achieved pneumococcal anticapsular immunoglobulin G concentrations ≥0.35 µg/mL for all serotypes except serotype 3 (86.2%), increasing to 98.1-100% for most serotypes (serotype 3: 93.6%) after the toddler dose. Local and systemic reactions were similar between groups.

CONCLUSIONS

Immune responses to MnCC-TT, and other childhood vaccines (DTaP-HBV-IPV/Hib, DTaP-IPV+Hib) were noninferior when concomitantly administered with PCV13 compared with PCV7. PCV13 does not interfere with MnCC-TT. PCV13 is highly immunogenic with a favorable safety profile.

Authors+Show Affiliations

Hospital Clínico Universitario de Santiago de Compostela, Spain, and Vaccine Research Unit, Instituto de Investigación Sanitaria de Santiago, Spain. federico.martinon.torres@sergas.esNo 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 availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22301472

Citation

Martinón-Torres, Federico, et al. "13-valent Pneumococcal Conjugate Vaccine Given With Meningococcal C-tetanus Toxoid Conjugate and Other Routine Pediatric Vaccinations: Immunogenicity and Safety." The Pediatric Infectious Disease Journal, vol. 31, no. 4, 2012, pp. 392-9.
Martinón-Torres F, Gimenez-Sanchez F, Gurtman A, et al. 13-valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety. Pediatr Infect Dis J. 2012;31(4):392-9.
Martinón-Torres, F., Gimenez-Sanchez, F., Gurtman, A., Bernaola, E., Diez-Domingo, J., Carmona, A., Sidhu, M., Sarkozy, D. A., Gruber, W. C., Emini, E. A., & Scott, D. A. (2012). 13-valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety. The Pediatric Infectious Disease Journal, 31(4), 392-9. https://doi.org/10.1097/INF.0b013e31824b972b
Martinón-Torres F, et al. 13-valent Pneumococcal Conjugate Vaccine Given With Meningococcal C-tetanus Toxoid Conjugate and Other Routine Pediatric Vaccinations: Immunogenicity and Safety. Pediatr Infect Dis J. 2012;31(4):392-9. PubMed PMID: 22301472.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 13-valent pneumococcal conjugate vaccine given with meningococcal C-tetanus toxoid conjugate and other routine pediatric vaccinations: immunogenicity and safety. AU - Martinón-Torres,Federico, AU - Gimenez-Sanchez,Francisco, AU - Gurtman,Alejandra, AU - Bernaola,Enrique, AU - Diez-Domingo,Javier, AU - Carmona,Alfonso, AU - Sidhu,Mohinder, AU - Sarkozy,Denise A, AU - Gruber,William C, AU - Emini,Emilio A, AU - Scott,Daniel A, AU - ,, PY - 2012/2/4/entrez PY - 2012/2/4/pubmed PY - 2012/7/17/medline SP - 392 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 4 N2 - BACKGROUND: As multiple vaccines are administered concomitantly during routine pediatric immunizations, it is important to ascertain the potential interference of any new vaccine on the immune response to the concomitantly administered vaccines. Immune responses to meningococcal serogroup C-tetanus toxoid conjugate vaccine (MnCC-TT) and the diphtheria and tetanus antigens in routine pediatric vaccines (diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenza type b [DTaP-HBV-IPV/Hib] and DTaP-IPV+Hib) when given concomitantly with the 13-valent pneumococcal conjugate vaccine (PCV13) were compared with responses when given with PCV7. In addition, the immunogenicity and safety of PCV13 were assessed. METHODS: Healthy infants were randomized to receive PCV13 or PCV7 (ages 2, 4, 6 and 15 months), concomitant with MnCC-TT (2, 4 and 15 months), DTaP-HBV-IPV/Hib (2, 4 and 6 months), and DTaP-IPV+Hib (15 months). RESULTS: Immune responses to MnCC-TT and to the diphtheria and tetanus antigens administered with PCV13 were noninferior to the responses observed when the vaccines were administered with PCV7; ≥96.6 (postinfant) and ≥99.4% (posttoddler) subjects achieved prespecified immune response levels to each antigen in each group. After the infant series, ≥93.0% of subjects receiving PCV13 achieved pneumococcal anticapsular immunoglobulin G concentrations ≥0.35 µg/mL for all serotypes except serotype 3 (86.2%), increasing to 98.1-100% for most serotypes (serotype 3: 93.6%) after the toddler dose. Local and systemic reactions were similar between groups. CONCLUSIONS: Immune responses to MnCC-TT, and other childhood vaccines (DTaP-HBV-IPV/Hib, DTaP-IPV+Hib) were noninferior when concomitantly administered with PCV13 compared with PCV7. PCV13 does not interfere with MnCC-TT. PCV13 is highly immunogenic with a favorable safety profile. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/22301472/13_valent_pneumococcal_conjugate_vaccine_given_with_meningococcal_C_tetanus_toxoid_conjugate_and_other_routine_pediatric_vaccinations:_immunogenicity_and_safety_ L2 - https://doi.org/10.1097/INF.0b013e31824b972b DB - PRIME DP - Unbound Medicine ER -