Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants.

@article{Block2017LottolotCS,
  title={Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants.},
  author={Stanley L. Block and Nicola P. Klein and Kwabena O. Sarpong and Stephen Russell and John A Fling and Maria Petrecz and Sheryl A Flores and Jin Xu and Guanghan Liu and Jon E. Stek and Ginamarie Foglia and Andrew Wen-Tseng Lee},
  journal={The Pediatric infectious disease journal},
  year={2017},
  volume={36 2},
  pages={
          202-208
        }
}
BACKGROUND This multicenter phase III study (NCT01340937) evaluated the consistency of immune responses to 3 separate lots of diphtheria-tetanus toxoids-acellular pertussis 5, inactivated poliovirus vaccine, Haemophilus influenzae type b, and hepatitis B (DTaP5-IPV-Hib-HepB), an investigational hexavalent vaccine (HV). METHODS Healthy infants were randomized (2:2:2:1) to receive HV or Pentacel (Control). Groups 1, 2 and 3 received HV at 2, 4 and 6 months, and Control at 15 months. Group 4… CONTINUE READING
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