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Immunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine.
J Pediatr. 2007 Jul; 151(1):43-9, 49.e1-2.JPed

Abstract

OBJECTIVE

To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7.

STUDY DESIGN

At 2, 4, and 6 months of age, infants received either DTaP-HepB-IPV plus PCV-7 and Hib (n = 199), separate vaccines (n = 188), or DTaP-HepB-IPV plus Hib with PCV-7 administered 2 weeks later (n = 188). Blood was drawn before and after vaccination. Parents reported symptoms for 4 days after each dose and adverse events throughout the entire study.

RESULTS

Immunogenicity in the Combination Vaccine Group was noninferior to that of the Separate and Staggered Vaccine Groups with respect to seroprotective rates for diphtheria, tetanus, and poliovirus and to geometric mean concentrations for pertussis. Seroprotective rates for HepB and Hib were not different between groups. Seropositivity for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever > or = 100.4 degrees F (38.0 degrees C) and some local symptoms compared with separate vaccines (exploratory P < .05). No group differences were observed in rates of symptoms for which parents sought medical advice.

CONCLUSIONS

DTaP-HepB-IPV was highly immunogenic and well tolerated when coadministered with Hib and PCV-7 at 2, 4, and 6 months of age.

Authors+Show Affiliations

University of Rochester Medical Center, Rochester, New York 14642, USA. michael_pichichero@urmc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17586189

Citation

Pichichero, Michael E., et al. "Immunogenicity and Safety of a Combination Diphtheria, Tetanus Toxoid, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus Vaccine Coadministered With a 7-valent Pneumococcal Conjugate Vaccine and a Haemophilus Influenzae Type B Conjugate Vaccine." The Journal of Pediatrics, vol. 151, no. 1, 2007, pp. 43-9, 49.e1-2.
Pichichero ME, Bernstein H, Blatter MM, et al. Immunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. J Pediatr. 2007;151(1):43-9, 49.e1-2.
Pichichero, M. E., Bernstein, H., Blatter, M. M., Schuerman, L., Cheuvart, B., & Holmes, S. J. (2007). Immunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. The Journal of Pediatrics, 151(1), 43-9, e1-2.
Pichichero ME, et al. Immunogenicity and Safety of a Combination Diphtheria, Tetanus Toxoid, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus Vaccine Coadministered With a 7-valent Pneumococcal Conjugate Vaccine and a Haemophilus Influenzae Type B Conjugate Vaccine. J Pediatr. 2007;151(1):43-9, 49.e1-2. PubMed PMID: 17586189.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. AU - Pichichero,Michael E, AU - Bernstein,Henry, AU - Blatter,Mark M, AU - Schuerman,Lode, AU - Cheuvart,Brigitte, AU - Holmes,Sandra J, AU - ,, PY - 2006/08/04/received PY - 2006/11/28/revised PY - 2007/02/02/accepted PY - 2007/6/26/pubmed PY - 2007/7/24/medline PY - 2007/6/26/entrez SP - 43-9, 49.e1-2 JF - The Journal of pediatrics JO - J Pediatr VL - 151 IS - 1 N2 - OBJECTIVE: To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7. STUDY DESIGN: At 2, 4, and 6 months of age, infants received either DTaP-HepB-IPV plus PCV-7 and Hib (n = 199), separate vaccines (n = 188), or DTaP-HepB-IPV plus Hib with PCV-7 administered 2 weeks later (n = 188). Blood was drawn before and after vaccination. Parents reported symptoms for 4 days after each dose and adverse events throughout the entire study. RESULTS: Immunogenicity in the Combination Vaccine Group was noninferior to that of the Separate and Staggered Vaccine Groups with respect to seroprotective rates for diphtheria, tetanus, and poliovirus and to geometric mean concentrations for pertussis. Seroprotective rates for HepB and Hib were not different between groups. Seropositivity for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever > or = 100.4 degrees F (38.0 degrees C) and some local symptoms compared with separate vaccines (exploratory P < .05). No group differences were observed in rates of symptoms for which parents sought medical advice. CONCLUSIONS: DTaP-HepB-IPV was highly immunogenic and well tolerated when coadministered with Hib and PCV-7 at 2, 4, and 6 months of age. SN - 1097-6833 UR - https://www.unboundmedicine.com/medline/citation/17586189/Immunogenicity_and_safety_of_a_combination_diphtheria_tetanus_toxoid_acellular_pertussis_hepatitis_B_and_inactivated_poliovirus_vaccine_coadministered_with_a_7_valent_pneumococcal_conjugate_vaccine_and_a_Haemophilus_influenzae_type_b_conjugate_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(07)00132-1 DB - PRIME DP - Unbound Medicine ER -