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. 2019 Jan 4;15(4):809–821. doi: 10.1080/21645515.2018.1549449

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© 2018 The Author(s). Published with license by Taylor & Francis Group, LLC.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Figure 1. — Study design.

, vaccination; , blood sampling; DTaP-HBV-IPV/Hib, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b (Hib) vaccine; DTaP-HBV-IPV, diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine; DTaP-IPV/Hib, diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Hib vaccine; DTaP, diphtheria, tetanus, acellular pertussis vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; HRV, human rotavirus vaccine, administered at 2 and 4 months of age only; HBV, hepatitis B vaccine (not given at 4 months of age if a dose was administered at birth or 30 days prior to enrollment); Hib_A, Hib_B, monovalent Hib conjugate vaccines; AE, adverse event; SAE, serious adverse event; NOCIs, new onset of chronic illnesses; ESFU, extended safety follow-up.Infants in Group 1 received one of three lots of DTaP-HBV-IPV/Hib, but these three groups were pooled for all analyses presented here. The final randomization scheme was (1:1:1):3:3.

Inline graphic — Study design.

, vaccination; , blood sampling; DTaP-HBV-IPV/Hib, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b (Hib) vaccine; DTaP-HBV-IPV, diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine; DTaP-IPV/Hib, diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Hib vaccine; DTaP, diphtheria, tetanus, acellular pertussis vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; HRV, human rotavirus vaccine, administered at 2 and 4 months of age only; HBV, hepatitis B vaccine (not given at 4 months of age if a dose was administered at birth or 30 days prior to enrollment); Hib_A, Hib_B, monovalent Hib conjugate vaccines; AE, adverse event; SAE, serious adverse event; NOCIs, new onset of chronic illnesses; ESFU, extended safety follow-up.Infants in Group 1 received one of three lots of DTaP-HBV-IPV/Hib, but these three groups were pooled for all analyses presented here. The final randomization scheme was (1:1:1):3:3.