biostudies-literatureKumar PBill & Melinda Gates FoundationBill &amp;amp; Melinda Gates Foundation609https://www.ebi.ac.uk/biostudies/studies/S-EPMC11209613biostudies-literatureUnknown12(6)Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated with Alhydrogel^® adjuvant, AH) combined with a mock multidose formulation of a pediatric pentavalent vaccine used in LMICs. This complex formulation contained (1) vaccine antigens (i.e., whole-cell pertussis (wP), diphtheria (D), tetanus (T), <i>Haemophilus influenza</i> (Hib), and hepatitis B (HepB), (2) a mixture of aluminum-salt adjuvants (AH and Adju-Phos^®, AP), and (3) a preservative (thimerosal, THVaccinesEvaluating the Compatibility of New Recombinant Protein Antigens (Trivalent NRRV) with a Mock Pentavalent Combination Vaccine Containing Whole-Cell Pertussis: Analytical and Formulation Challenges.PMC11209613INV-009301OPP1212920Saleh-Birdjandi SVolkin DBSecrist KJoshi SBDotson BAdewunmi YTaskar PHolland DAMantis NJKumar PDoering JfalseEvaluating the Compatibility of New Recombinant Protein Antigens (Trivalent NRRV) with a Mock Pentavalent Combination Vaccine Containing Whole-Cell Pertussis: Analytical and Formulation Challenges.Introducing new recombinant protein antigens to existing pediatric combination vaccines is important in improving coverage and affordability, especially in low- and middle-income countries (LMICs). This case-study highlights the analytical and formulation challenges encountered with three recombinant non-replicating rotavirus vaccine (NRRV) antigens (t-NRRV formulated with Alhydrogel^® adjuvant, AH) combined with a mock multidose formulation of a pediatric pentavalent vaccine used in LMICs. This complex formulation contained (1) vaccine antigens (i.e., whole-cell pertussis (wP), diphtheria (D), tetanus (T), <i>Haemophilus influenza</i> (Hib), and hepatitis B (HepB), (2) a mixture of aluminum-salt adjuvants (AH and Adju-Phos^®, AP), and (3) a preservative (thimerosal, TH2024-01-01T00:00:00Z2024 Jun2026-05-05T03:21:19.304Z2025-04-04T21:22:41.512ZS-EPMC112096133893233810.3390/vaccines12060609