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

13 months

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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 - PowerPoint PPT Presentation

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Page 1: 13 months

13 months

12.5 months

14 months

Infant Stage

Randomization

Toddler Stage

Randomization

Primary immunization at 2, 3, 4 months

Group 1

1b 1c

MenCCDTP-Hib

OPV

1a

Serum MenACP

Serum MenCCMMR

Serum MenCC

Serum MMR

Serum MMR

Serum MMR

Group 2

2b 2c

HepBDTP-Hib

OPV

2a

Serum MenACP

Serum MenCCMMR

Serum MenCC

Serum MMR

Serum MMR

Serum MMR

Page 2: 13 months

Randomized

Completed Phase 1

Enrolled

Randomized

Enrolled

Received MCC/MACPS *

ELISA ITT

SBA ITT

Infant Stage

Toddler Stage

248

Group 1: 124 Group 2: 124

122 121

118 118

1a: 25 1b: 49 1c: 44 2a: 23 2b: 48 2c: 47

4 lost to follow up/withdrew

3 lost to follow up/withdrew

24

23

47

43

44

42

23

22

47

40

46

42

17 35 36 19 39 34

£8000 monthly income in 13 months,

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