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2 results on '"DTwP-HepB-Hib"'

1. Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants

Author

Mandeep S. Dhingra, Suresh Ravinuthala, Madhu Gupta, Leni G. Mathew, Sandeep B Bavdekar, Shiv D. Sharma, Mandyam Dhati Ravi, Arijit Sil, Dulari J. Gandhi, Ritabrata Kundu, Anand Prakash Dubey, Midde V. Jayanth, Sangappa M. Dhaded, Sanjay Lalwani, and Jugesh Chhatwal

Subjects
safety, Male, 0301 basic medicine, Pediatrics, medicine.medical_specialty, Haemophilus Infections, Whooping Cough, whole-cell pertussis, Immunology, Immunization, Secondary, India, Booster dose, immunogenicity, Antibodies, Viral, Pentavalent vaccine, 03 medical and health sciences, Immunogenicity, Vaccine, Immune system, Antigen, Humans, Immunology and Allergy, Medicine, lot-to-lot consistency, Hepatitis B Vaccines, Single-Blind Method, Vaccines, Combined, DtwP-HepB-Hib vaccine, Diphtheria-Tetanus-Pertussis Vaccine, Haemophilus Vaccines, pentavalent vaccine, Pharmacology, business.industry, Immunogenicity, Vaccination, Infant, Hepatitis B, Research Papers, Antibodies, Bacterial, 030112 virology, Immunization, Cohort, Female, business, DTwP-HepB-Hib
Abstract

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.

Published
2015
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2. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants.

Author

Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, and Lattanzi M

Subjects
Diphtheria-Tetanus-Pertussis Vaccine administration & dosage, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Erythema chemically induced, Erythema epidemiology, Female, Fever chemically induced, Fever epidemiology, Haemophilus Vaccines administration & dosage, Hepatitis B Vaccines administration & dosage, Humans, India, Infant, Male, Antibodies, Bacterial blood, Diphtheria-Tetanus-Pertussis Vaccine adverse effects, Diphtheria-Tetanus-Pertussis Vaccine immunology, Haemophilus Vaccines adverse effects, Haemophilus Vaccines immunology, Hepatitis B Antibodies blood, Hepatitis B Vaccines adverse effects, Hepatitis B Vaccines immunology, Vaccination adverse effects, Vaccination methods
Abstract

Compliance with recommended vaccinations for Indian infants is facilitated by using combination vaccines to minimize the number of required injections. The ready-to-use, preservative free, fully-liquid combination DTwP-HepB-Hib vaccine, Quinvaxem(®), offers convenience of administering five important vaccine antigens to infants in a single injection. This phase III, single-arm, multicenter study was designed to assess immunogenicity and safety of three doses of Quinvaxem(®) to Indian infants administered at 6, 10, and 14 weeks of age. Blood samples were taken prior to the first dose and at one month post last vaccination. Infants were observed clinically for any reaction approximately 30 min following each vaccination, and parents completed subject diaries for solicited local, systemic and any adverse events (AEs) following over a 5 d period. DTwP-HepB-Hib vaccine elicited strong immune responses that exceeded seroprotection/seroconversion thresholds against all vaccine antigens. At one month after third vaccination, percentages of infants achieving predefined protective antibody levels were 99% diphtheria; 100% tetanus; 98% Hepatitis B; 100% Hib short-term (≥ 0.15 µg/mL); 95% Hib long-term (≥ 1.0 µg/mL) protection; and relevant immune response was 99% for pertussis. The vaccine was well tolerated, with no vaccine-related serious AEs. Only one case of high fever (≥ 40 °C) was reported. The most frequently reported reactions were mild to moderate tenderness and erythema. Frequencies of all AEs declined with subsequent vaccinations. This study demonstrated that this convenient, fully-liquid DTwP-HepB-Hib vaccine is highly immunogenic and has a acceptable safety profile for use in Indian infants. ClinicalTrials.gov Identifier: NCT01470287. Clinical Trials Registry of India Number: CTRI/2011/11/002118.

Published
2013
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