Table 2:
Group | Original study | Follow-up study | ||||||
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Enrolled (Oxford)* | Completed (Oxford)* | At baseline | At 1 mo | At 2 mo | At 3 mo | |||
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Enrolled | Included in ITT analysis for persistence† | Received first dose | Included in ITT analysis for immunogenicity† | Received second dose | Included in ITT analysis for immunogenicity† | |||
4CMenB246-12‡ | 50 (46) | 45 (41) | 19 | 17 | 19 | 19 | NA | NA |
| ||||||||
rMenB246-12§ | 48 (44) | 44 (40) | 29 | 29 | 29 | 28 | NA | NA |
| ||||||||
4CMenB-12¶ | 24 (22) | 23 (21) | 8 | 8 | 8 | 7 | 8 | 8 |
| ||||||||
rMenB-12** | 25 (23) | 24 (23) | 14 | 14 | 14 | 13 | 14 | 13 |
| ||||||||
Control†† | NA | NA | 43 | 40 | 42 | 38 | 41 | 36 |
4CMenB = multicomponent serogroup B meningococcal vaccine, ITT = intention-to-treat, NA = not applicable, rMenB = recombinant protein serogroup B meningococcal vaccine.
Because the follow-up study was a single-centre study, only participants recruited from Oxford (in parentheses) in the original study were invited to participate in the follow-up study.
Exclusions from the ITT analysis are due to lack of evaluable serum sample, except for 1 participant in the control group who withdrew consent.
Participants who received 4 doses of 4CMenB vaccine at 2, 4, 6 and 12 months.
Participants who received 4 doses of rMenB vaccine at 2, 4, 6 and 12 months.
Participants who received 1 dose of 4CMenB at 12 months.
Participants who received 1 dose of rMenB vaccine at 12 months.
Participants with no previous exposure to 4CMenB or rMenB vaccines.