Abstract
Background: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. Methods: A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (. N=. 2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (. N=. 1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4. Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios
| Original language | English |
|---|---|
| Pages (from-to) | 3360-3368 |
| Number of pages | 9 |
| Journal | Vaccine |
| Volume | 30 |
| Issue number | 23 |
| DOIs | |
| State | Published - May 14 2012 |
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All Science Journal Classification (ASJC) codes
- Immunology and Microbiology(all)
- Infectious Diseases
- Public Health, Environmental and Occupational Health
- veterinary(all)
- Molecular Medicine
Cite this
Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers : A randomized, controlled, open-label, multicenter study. / Chatterjee, Archana; O'Keefe, Catherine; Varman, Meera; Klein, Nicola P.; Luber, Stephen; Tomovici, Antigona; Noriega, Fernando.
In: Vaccine, Vol. 30, No. 23, 14.05.2012, p. 3360-3368.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers
T2 - A randomized, controlled, open-label, multicenter study
AU - Chatterjee, Archana
AU - O'Keefe, Catherine
AU - Varman, Meera
AU - Klein, Nicola P.
AU - Luber, Stephen
AU - Tomovici, Antigona
AU - Noriega, Fernando
PY - 2012/5/14
Y1 - 2012/5/14
N2 - Background: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. Methods: A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (. N=. 2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (. N=. 1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4. Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios
AB - Background: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. Methods: A randomized, controlled, open-label, 4-armed, multicenter study in healthy, full-term infants (42-89 days of age) was conducted in 38 centers across the United States. Participants were randomized 1:1:1:1 to a control vaccine group (3 doses DTaP, IPV, and Hib and at Dose 4 DTaP and Hib) and 3 combination vaccine groups: (1) 3 doses PENTA, then Dose 4 DTaP and Hib; (2) 4 QUAD doses and Hib; (3) 4 PENTA doses. Participants (. N=. 2167) were immunized at 2, 4, and 6 months of age, Dose 4 participants (. N=. 1832) at 15 months of age. Immunogenicity was assessed before Doses 1 and 4 and after Doses 3 and 4. Safety was assessed 30 days after each dose and through 180 days Post-Dose 4. Results: Antibody responses and geometric mean concentrations/geometric mean titers (GMCs/GMTs) elicited by each combination vaccine were noninferior (upper-bound 90% confidence interval of GMC/GMT ratios
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U2 - 10.1016/j.vaccine.2012.03.057
DO - 10.1016/j.vaccine.2012.03.057
M3 - Article
VL - 30
SP - 3360
EP - 3368
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 23
ER -