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13 months

Group 2. Group 1. MenCC DTP-Hib OPV. HepB DTP-Hib OPV. 1a. 2a. 2b. 1b. 2c. 1c. Serum MenACP. Serum MenACP. Serum MenCC MMR. Serum MenCC MMR. Serum MenCC. Serum MenCC. Serum MMR. Serum MMR. Serum MMR. Serum MMR. Serum MMR. Serum MMR. Infant Stage

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13 months

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  1. Group 2 Group 1 MenCC DTP-Hib OPV HepB DTP-Hib OPV 1a 2a 2b 1b 2c 1c Serum MenACP Serum MenACP Serum MenCC MMR Serum MenCC MMR Serum MenCC Serum MenCC Serum MMR Serum MMR Serum MMR Serum MMR Serum MMR Serum MMR Infant Stage Randomization Primary immunization at 2, 3, 4 months Toddler Stage Randomization 12.5 months 13 months 14 months

  2. 248 Group 1: 124 Group 2: 124 122 121 4 lost to follow up/withdrew 3 lost to follow up/withdrew 118 118 1a: 25 1b: 49 1c: 44 2a: 23 2b: 48 2c: 47 24 47 44 23 47 46 23 43 42 22 40 42 17 35 36 19 39 34 Infant Stage Enrolled Randomized Completed Phase 1 Toddler Stage Enrolled Randomized Received MCC/MACPS * ELISA ITT SBA ITT

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