Related Experiment Video
Updated: May 23, 2026
Evaluation of Host-Pathogen Responses and Vaccine Efficacy in Mice
Published on: February 22, 2019
Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a
Archana Chatterjee1, Catherine O'Keefe, Meera Varman
1Creighton University School of Medicine, Omaha, NE 68131, USA. achatter@creighton.edu
Insights
Pentavalent (PENTA) and quadrivalent (QUAD) vaccines showed similar safety and immunogenicity to control vaccines in infants. These combination vaccines offer flexibility for use based on local preference or availability.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Investigated interchangeability of pentavalent (PENTA) and quadrivalent (QUAD) combination vaccines from the same manufacturer.
- Assessed suitability for tailoring vaccine use to local preference or availability.
Purpose of the Study:
- To compare the immunogenicity and safety of PENTA and QUAD vaccines against control vaccines in infants.
- To determine if PENTA and QUAD vaccines are interchangeable for infant immunization schedules.
Main Methods:
- Conducted a randomized, controlled, open-label, 4-armed, multicenter study in 2167 healthy infants across the US.
- Administered PENTA, QUAD, and control vaccines at 2, 4, and 6 months, with a fourth dose at 15 months.
- Assessed immunogenicity via antibody responses and safety through adverse event monitoring post-vaccination.
Main Results:
- Combination vaccines demonstrated noninferior antibody responses compared to controls, except for lower pertactin GMCs with PENTA.
- Fever rates were noninferior across groups, though slightly higher with QUAD and Hib compared to control.
- No clinically significant differences in immunogenicity or safety profiles were observed between PENTA, QUAD, and control vaccines.
Conclusions:
- Pentavalent (PENTA) and quadrivalent (QUAD) vaccines exhibit comparable safety and immunogenicity to separately administered control vaccines.
- These findings support the interchangeability of PENTA and QUAD vaccines, allowing for flexible use in infant immunization programs.
- Study registered on ClinicalTrials.gov (NCT ID: NCT00255047).
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 <1.5) to control vaccines except pertactin GMCs were higher after 4 control DTaP doses (157.46 EU/mL) than after Dose 4 with DTaP and Hib (after a PENTA infant series) (111.70 EU/mL) and after 4 PENTA doses (98.00 EU/mL). Fever rates in the combination vaccine groups were noninferior (upper bound 95% CI of combination vaccine group fever rate minus control vaccine group fever rate <10%) to the control vaccine group except the rate after 4 QUAD and Hib doses (23.5%) was higher than after 4 control DTaP doses (13.9%).
Conclusions:
PENTA and QUAD had similar safety profiles and no clinically important differences in immunogenicity compared with separately administered control vaccines. ClinicalTrials.gov (NCT ID: NCT00255047).
More Related Videos
13:47Opsono-Adherence Assay to Evaluate Functional Antibodies in Vaccine Development Against Bacillus anthracis and Other Encapsulated Pathogens
Published on: May 19, 2020
05:44A Rapid, Simple, and Standardized Homogenization Method to Prepare Antigen/Adjuvant Emulsions for Inducing Experimental Autoimmune Encephalomyelitis
Published on: December 9, 2022
Related Concept Videos
01:21Vaccines
01:51Vaccinations