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Open, Randomized, Phase-II Study to Assess the Reactogenicity and Immunogenicity of an 11-Valent Pneumococcal-Protein D (11-Pn) Vaccine when Co-Administered in a Separate Injection at the Same or Different Time Points than Measles-Mumps-Rubella (MMR) Vaccine in Children 12-15 Months of Age.

ARGUEDAS A, LOAIZA C, SOLEY C, PEREZ A, CERVANTES Y, RUBIO P, THOELEN S; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. G-896.

Instituto de Atencion Pediatrica, San Jose, Costa Rica.

BACKGROUND: Conjugate pneumococcal vaccines can reduce the burden of S. pneumoniae (Pn) infections in children. METHODS: Open, randomized, single center study to access the safety, reactogenicity and immune response to MMR, in MMR naive children 12 to 15 months, when administered concomitantly (Group 1) or at different time intervals (Group 2) with a Protein D conjugated 11-valent-Pn vaccine (serotypes 1,3,4,5,6B,7F,9V,14,18C, 19F and 23F). Group 1 received MMR+11-Pn at visit 1 and a second dose of 11-Pn at visit 2 (42 to 56 days later). Group 2 received MMR at visit 1 followed by 11-Pn at visits 2 and 3 (time interval 42 to 56 days between visits). All participants had a blood sample drawn before application of the first vaccine and at 42 - 56 days post visit 1. Additionally, Group 2 had another blood sample obtained 1 month after visit 3. RESULTS: 100 subjects were included (50 per group). Unsolicited and solicited vaccine reactions (fever drowsiness / irritability, loss of appetite) were similar between both groups with no increase in local MMR reactogenicity in Group 1. In Group 1, the observed incidence of solicited symptom decrease from dose 1 to dose 2. The immune response to MMR antigens was unaffected and similar in both groups. A satisfactory immune response to all 11-Pn antibodies was induced in both groups. CONCLUSION: These preliminary data show similar reactogenicity and immunogenicity when MMR is given separately or co-administered with 11-Pn.

Publication Types:
  • Meeting Abstracts
Keywords:
  • Aged
  • Child
  • Evaluation Studies
  • Humans
  • Immune Sera
  • Measles
  • Measles Vaccine
  • Measles virus
  • Measles-Mumps-Rubella Vaccine
  • Mumps
  • Mumps Vaccine
  • Mumps virus
  • Pain
  • Pneumococcal Vaccines
  • Rubella
  • Rubella Vaccine
  • Rubella virus
  • Streptococcus pneumoniae
  • Vaccines, Conjugate
  • immunology
Other ID:
  • GWAIDS0026241
UI: 102265865

From Meeting Abstracts




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