Immunogenicity and safety of a combination pneumococcal-meningococcal vaccine in infants: a randomized controlled trial.
2005
ContextThe success of conjugate vaccines in decreasing invasive disease due
to Streptococcus pneumoniae and group C Neisseria meningitidis has placed pressure on crowded infant immunization
schedules, making development of combination vaccines a priority.ObjectiveTo determine the safety and immunogenicity of a combination 9-valent
pneumococcal–group C meningococcal conjugate candidate vaccine (Pnc9-MenC)
administered as part of the routine UK infant immunization schedule at ages
2, 3, and 4 months.Design, Setting, and ParticipantsPhase 2 randomized controlled trial conducted from August 2000 to January
2002 and enrolling 240 healthy infants aged 7 to 11 weeks from 2 UK centers,
with home follow-up visits at ages 2, 3, 4, and 5 months.InterventionPnc9-MenC (n = 120) or monovalent group C meningococcal conjugate
vaccine (MenC) (n = 120) administered in addition to routine immunizations
(diphtheria and tetanus toxoids and whole-cell pertussis [DTwP], Haemophilus influenzae type b [Hib] polyribosylribitol phosphate-tetanus
toxoid protein conjugate, oral polio vaccine).Main Outcome MeasuresGroup C meningococcal immunogenicity measured by serum bactericidal
titer (SBT) 1 month following the third dose; rates of postimmunization reactions.ResultsMenC component immunogenicity was reduced in the Pnc9-MenC vs the MenC
group (geometric mean SBT, 179 [95% confidence interval {CI}, 133-243] vs
808 [95% CI, 630-1037], respectively; P<.001).
The proportion with group C meningococcal SBT greater than 1:8 was lower in
the Pnc9-MenC vs the MenC group (95% vs 100%, P = .05).
The geometric mean concentration of antibodies to concomitantly administered
Hib vaccine was reduced in the Pnc9-MenC vs the MenC group (2.11 [95% CI,
1.57-2.84] μg/mL vs 3.36 [95% CI, 2.57-4.39] μg/mL; P = .02), as were antibodies against diphtheria (0.74 [95%
CI, 0.63-0.87] μg/mL vs 1.47 [95% CI, 1.28-1.69] μg/mL; P<.001). Pnc9-MenC was immunogenic for each of 9 contained pneumococcal
serotypes, with responses greater than 0.35 μg/mL observed in more than
88% of infants. Increased irritability and decreased activity were observed
after the third dose in the Pnc9-MenC group.ConclusionsPnc9-MenC combination vaccine administered to infants at ages 2, 3,
and 4 months demonstrated reduced group C meningococcal immunogenicity compared
with MenC vaccine. The immunogenicity of concomitantly administered Hib and
DTwP vaccines was also diminished. The Pnc9-MenC vaccine was safe and immunogenic
for all contained pneumococcal serotypes. The reduced MenC immunogenicity
may limit the development of the Pnc9-MenC vaccine.
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