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EXPERIMENTAL CLINICAL INVESTIGATION

Validation of Serological Correlate of Protection for Meningococcal C Conjugate Vaccine by Using Efficacy Estimates from Postlicensure Surveillance in England

Nick Andrews, Ray Borrow, Elizabeth Miller
Nick Andrews
1Immunisation Division, PHLS Communicable Disease Surveillance Centre, London NW9 5EQ
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Ray Borrow
2PHLS Meningococcal Reference Unit, Withington Hospital, Manchester M20 2LR, United Kingdom
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Elizabeth Miller
1Immunisation Division, PHLS Communicable Disease Surveillance Centre, London NW9 5EQ
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  • For correspondence: emiller@phls.org.uk
DOI: 10.1128/CDLI.10.5.780-786.2003
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    FIG. 1.

    Efficacy predicted on the basis of the proportions of unvaccinated and vaccinated individuals with titers below the different rSBA cutoffs measured 1 month following vaccination with the MCC vaccine.

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    FIG. 2.

    Efficacy predicted on the basis of the proportions of unvaccinated and vaccinated individuals with titers below the different rSBA cutoffs measured 9 months (infants) or 7 months (toddlers) months following vaccination with the MCC vaccine.

Tables

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  • TABLE 1.

    Distribution of rSBA titers after vaccination with MCC vaccine by age when vaccination was completed and time since vaccination

    SBA titerNo. of individuals at the indicated times postvaccination:
    Infants (age, 4-5 mo)Toddlers (age, 12-14 mo)Preschool children (age, 3-4 yr), 1 mo
    1 mo9 mo1 mo7 mo
    <40133100
    4110360
    803303
    1603362
    3204791
    6413436
    128+51144731110
        Total53507065122
  • TABLE 2.

    Distribution of rSBA titers in an unvaccinated population

    SBA titerNo. of individuals
    Infants (age, 3-11 mo)Toddlers (age, 12-23 mo)Preschool children (age, 2-4 yr)
    <4142225189
    4686
    85112
    16542
    32264
    64341
    128+695
        Total169267209
  • TABLE 3.

    Predicted vaccine efficacy and 95% CIs estimated for unvaccinated and vaccinated children with titers below the different SBA cutoffs 1 month after vaccination with the MCC vaccine measured by SBA

    Group and cutoff% Individuals with titers below cutoffPredicted % vaccine efficacy (95% CI)
    VaccinatedUnvaccinated
    Infants
        1:40.084.0100 (86-100)
        1:81.987.698 (85-100)
        1:161.990.598 (86-100)
        1:321.993.598 (84-100)
        1:641.994.798 (86-100)
        1:1283.896.496 (85-99)
    Toddlers
        1:44.384.395 (85-98)
        1:88.687.390 (79-95)
        1:1612.991.486 (74-92)
        1:3217.192.982 (69-89)
        1:6427.195.171 (58-81)
        1:12832.996.666 (52-76)
    Preschool children
        1:40.090.4100 (95-100)
        1:80.093.3100 (95-100)
        1:162.594.397 (92-99)
        1:324.195.296 (90-98)
        1:644.997.195 (89-98)
        1:1289.897.690 (83-94)
  • TABLE 4.

    Predicted vaccine efficacy and 95% CIs estimated for unvaccinated and vaccinated infants and toddlers with titers below the different SBA cutoffs 7 to 9 months after vaccination with the MCC vaccine measured by SBA

    Group and cutoff% Individuals with titers below cutoffPredicted % vaccine efficacy (95% CI)
    VaccinatedUnvaccinated
    Infants
        1:426.084.069 (50-81)
        1:846.087.647 (29-61)
        1:1652.090.543 (25-56)
        1:3258.093.538 (21-51)
        1:6466.094.730 (15-43)
        1:12872.096.424 (9-36)
    Toddlers
        1:415.484.382 (68-90)
        1:824.687.372 (57-82)
        1:1624.691.473 (59-82)
        1:3233.892.964 (49-74)
        1:6447.795.150 (35-61)
        1:12852.396.646 (32-57)
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Validation of Serological Correlate of Protection for Meningococcal C Conjugate Vaccine by Using Efficacy Estimates from Postlicensure Surveillance in England
Nick Andrews, Ray Borrow, Elizabeth Miller
Clinical and Diagnostic Laboratory Immunology Sep 2003, 10 (5) 780-786; DOI: 10.1128/CDLI.10.5.780-786.2003

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Validation of Serological Correlate of Protection for Meningococcal C Conjugate Vaccine by Using Efficacy Estimates from Postlicensure Surveillance in England
Nick Andrews, Ray Borrow, Elizabeth Miller
Clinical and Diagnostic Laboratory Immunology Sep 2003, 10 (5) 780-786; DOI: 10.1128/CDLI.10.5.780-786.2003
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