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Randomised, controlled trial of concomitant pneumococcal and meningococcal conjugate vaccines.
Vaccine. 2010 Nov 16; 28(49):7779-86.V

Abstract

A randomised, open-label study compared the immunogenicity and safety of 7-valent pneumococcal conjugate vaccine (PCV7) and meningococcal C conjugate vaccine (MnCC vaccine) administered concomitantly and individually. Infants received PCV7+MnCC vaccine (n=265), PCV7 alone (n=268) or MnCC vaccine alone (n=178). PCV7 was administered at 2, 3½, 6 and 12 months, and MnCC vaccine at 2, 6 and 12 months. For the 7 pneumococcal serotypes tested (4, 6B, 9V, 14, 18C, 19F and 23F), proportions of subjects with pneumococcal serotype-specific immunoglobulin G (IgG) antibody concentrations ≥0.35 μg/mL post-infant series were non-inferior for the PCV7+MnCC vaccine (91.5-99.6%) and PCV7 (89.0-99.6%) groups. Proportions of subjects achieving serogroup C meningococcal serum bactericidal assay titres ≥1:8 post-infant series were non-inferior for the PCV7+MnCC vaccine (99.6%) and MnCC vaccine groups (98.8%). Pneumococcal IgG antibody levels were similar in the PCV7+MnCC vaccine and PCV7 groups at each time point. Post-infant and post-toddler meningococcus C serum bactericidal assay titres and IgG levels were similar in the PCV7+MnCC vaccine and MnCC groups, although pre-toddler, the levels were lower in the PCV7+MnCC vaccine group than the MnCC vaccine group. Immune response rates to diphtheria antigen approached 100% for all vaccine groups. Local reactions were mostly similar among the treatment groups. The MnCC vaccine group had lower rates of some systemic events than the PCV7+MnCC vaccine group. Immune responses to PCV7+MnCC vaccine were non-inferior compared with those seen with each vaccine administered alone.

Authors+Show Affiliations

Poznan University of Medical Sciences, Poznan, Poland.No 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
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20883736

Citation

Wysocki, J, et al. "Randomised, Controlled Trial of Concomitant Pneumococcal and Meningococcal Conjugate Vaccines." Vaccine, vol. 28, no. 49, 2010, pp. 7779-86.
Wysocki J, Tansey S, Brachet E, et al. Randomised, controlled trial of concomitant pneumococcal and meningococcal conjugate vaccines. Vaccine. 2010;28(49):7779-86.
Wysocki, J., Tansey, S., Brachet, E., Baker, S., Gruber, W., Giardina, P., & Arora, A. (2010). Randomised, controlled trial of concomitant pneumococcal and meningococcal conjugate vaccines. Vaccine, 28(49), 7779-86. https://doi.org/10.1016/j.vaccine.2010.09.047
Wysocki J, et al. Randomised, Controlled Trial of Concomitant Pneumococcal and Meningococcal Conjugate Vaccines. Vaccine. 2010 Nov 16;28(49):7779-86. PubMed PMID: 20883736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised, controlled trial of concomitant pneumococcal and meningococcal conjugate vaccines. AU - Wysocki,J, AU - Tansey,S, AU - Brachet,E, AU - Baker,S, AU - Gruber,W, AU - Giardina,P, AU - Arora,A, Y1 - 2010/09/28/ PY - 2010/06/08/received PY - 2010/09/07/revised PY - 2010/09/13/accepted PY - 2010/10/2/entrez PY - 2010/10/5/pubmed PY - 2011/3/24/medline SP - 7779 EP - 86 JF - Vaccine JO - Vaccine VL - 28 IS - 49 N2 - A randomised, open-label study compared the immunogenicity and safety of 7-valent pneumococcal conjugate vaccine (PCV7) and meningococcal C conjugate vaccine (MnCC vaccine) administered concomitantly and individually. Infants received PCV7+MnCC vaccine (n=265), PCV7 alone (n=268) or MnCC vaccine alone (n=178). PCV7 was administered at 2, 3½, 6 and 12 months, and MnCC vaccine at 2, 6 and 12 months. For the 7 pneumococcal serotypes tested (4, 6B, 9V, 14, 18C, 19F and 23F), proportions of subjects with pneumococcal serotype-specific immunoglobulin G (IgG) antibody concentrations ≥0.35 μg/mL post-infant series were non-inferior for the PCV7+MnCC vaccine (91.5-99.6%) and PCV7 (89.0-99.6%) groups. Proportions of subjects achieving serogroup C meningococcal serum bactericidal assay titres ≥1:8 post-infant series were non-inferior for the PCV7+MnCC vaccine (99.6%) and MnCC vaccine groups (98.8%). Pneumococcal IgG antibody levels were similar in the PCV7+MnCC vaccine and PCV7 groups at each time point. Post-infant and post-toddler meningococcus C serum bactericidal assay titres and IgG levels were similar in the PCV7+MnCC vaccine and MnCC groups, although pre-toddler, the levels were lower in the PCV7+MnCC vaccine group than the MnCC vaccine group. Immune response rates to diphtheria antigen approached 100% for all vaccine groups. Local reactions were mostly similar among the treatment groups. The MnCC vaccine group had lower rates of some systemic events than the PCV7+MnCC vaccine group. Immune responses to PCV7+MnCC vaccine were non-inferior compared with those seen with each vaccine administered alone. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20883736/Randomised_controlled_trial_of_concomitant_pneumococcal_and_meningococcal_conjugate_vaccines_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)01357-5 DB - PRIME DP - Unbound Medicine ER -