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Safety, immunogenicity and non-interference of concomitant Typhoid Vi capsular polysaccharide-tetanus toxoid conjugate vaccine (Typbar-TCV®) and measles or measles-mumps-rubella vaccines in 8-9 months-old Indian children.
Vadrevu, Krishna Mohan; Dugyala, Raju; Mahantashetti, Niranjana Shamulinga; Khalatkar, Vasant; Murthy, Krishna; Mogre, Sandeep; Mitra, Monjori.
Afiliação
  • Vadrevu KM; Bharat Biotech International Ltd, Hyderabad, India.
  • Dugyala R; Bharat Biotech International Ltd, Hyderabad, India.
  • Mahantashetti NS; KLE Hospital, Belgaum, India.
  • Khalatkar V; Khalatkar Hospital, Nagpur, India.
  • Murthy K; Cheluvambha Hospital, Mysore, India.
  • Mogre S; Mogre Childrens Hospital, Nagpur, India.
  • Mitra M; Institute of Child Health, Kolkata, India.
Hum Vaccin Immunother ; 18(7): 2150030, 2022 12 30.
Article em En | MEDLINE | ID: mdl-36476258
ABSTRACT
We evaluated safety, reactogenicity, and immunogenicity when the WHO-prequalified single-dose Typhoid Vi-polysaccharide conjugate vaccine, Typbar-TCV®, was administered concomitantly with measles (MV) or measles-mumps-rubella (MMR) vaccines in 8- or 9-month-old children. We enrolled 493 children who were randomized 2111 to four groups to receive either TCV (0.5 mL intramuscularly) and MV (0.5 ml subcutaneously) concomitantly at 9 months of age (Group 1) with two subgroups given TCV booster 28 days (Group 1A) or 180 days (Group 1B) later, or MV on Day 0 and TCV on Day 28 (Group 2); or TCV at 8 months of age and MV 28 days later (Group 3), or MV only at 9 months of age (Group 4). All children received MMR at 15 months of age. We observed no statistically significant differences between group rates of solicited or unsolicited adverse events assessed throughout the study. Seroconversion rates for measles, mumps, and rubella antibodies were unaffected by concomitant administration with TCV, being similar in Groups 1, 2, and 3 and comparable to Group 4 (Control). IgG anti-Vi antibody titers were similar in all groups after primary Typbar-TCV® vaccination and were not increased by a second dose 28 days later. A small response to a booster dose of Typbar-TCV® given at 180 days did not achieve the high titers observed after the first dose, suggesting that booster vaccination may be more effective after a longer interval than 6 months. Typbar-TCV® can be safely co-administered with measles and MMR vaccines in children aged ≥9 months.Clinical trial registration number CTRI/2014/04/004532.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Febre Tifoide / Vacina contra Sarampo-Caxumba-Rubéola / Sarampo / Caxumba Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Febre Tifoide / Vacina contra Sarampo-Caxumba-Rubéola / Sarampo / Caxumba Idioma: En Ano de publicação: 2022 Tipo de documento: Article