Immunogenicity and safety study of a new DTaP–IPV–Hep B–PRP-T combined vaccine compared to a licensed DTaP–IPV–Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants

• Published in: International journal of infectious diseases Vol. 15; no. 4; pp. e249 - e256
• Main Authors: Kosalaraksa, Pope, Thisyakorn, Usa, Benjaponpitak, Suwat, Chokephaibulkit, Kulkanya, Santos-Lima, Eduardo
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01-04-2011
• Subjects: Antibodies, Bacterial - blood; Antibodies, Viral - blood; Co-administration; Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology; Drug Therapy, Combination; Haemophilus Vaccines - administration & dosage; Haemophilus Vaccines - adverse effects; Haemophilus Vaccines - immunology; Hepatitis B Vaccines - administration & dosage; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Heptavalent Pneumococcal Conjugate Vaccine; Hexavalent; Hexaxim; Humans; Immunization Schedule; Infant; Infectious Disease; Pediatric; Pneumococcal Vaccines - administration & dosage; Pneumococcal Vaccines - adverse effects; Pneumococcal Vaccines - immunology; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; Prevnar; Pulmonary/Respiratory; Thailand; Treatment Outcome; Vaccination; Vaccine; Vaccines, Combined - administration & dosage; Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology; Thailand; Co-administration; Vaccine; Hexaxim; Pediatric; Prevnar; Hexavalent
• ISSN: 1201-9712; 1878-3511
• DOI: 10.1016/j.ijid.2010.12.004

Summary Objective To assess a new, fully-liquid, hexavalent DTaP–IPV–Hep B–PRP-T vaccine (diphtheria toxoid (D), tetanus toxoid (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (Hep B), and Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (PRP-T) antigens) compared to a licensed DTaP–IPV–Hep B//PRP-T vaccine following primary series co-administration with a 7-valent pneumococcal conjugate vaccine (PCV7). Methods This was a randomized, phase III, observer-blind study in Thai infants ( N = 412), who received DTaP–IPV–Hep B–PRP-T or DTaP–IPV–Hep B//PRP-T at 2, 4, and 6 months of age, co-administered with PCV7. All received Hep B at birth. Non-inferiority for Hep B ≥10 mIU/ml and PRP ≥0.15 μg/ml was analyzed (DTaP–IPV–Hep B–PRP-T relative to DTaP–IPV–Hep B//PRP-T) at 1 month post-primary. Seroprotection/seroconversion and geometric mean titers (GMTs) were analyzed descriptively for all hexavalent components. Safety was evaluated from parental reports. Results Anti-Hep B and anti-PRP antibody seroprotection rates were high for DTaP–IPV–Hep B–PRP-T ( n = 189) and DTaP–IPV–Hep B//PRP-T ( n = 190), and non-inferiority was demonstrated. Anti-D and anti-T ≥0.01 IU/ml, anti-polio types 1, 2, and 3 ≥8 (1/dil), and anti-PT and anti-FHA seroconversion were high and similar in each group. For DTaP–IPV–Hep B–PRP-T and DTaP–IPV–Hep B//PRP-T, anti-Hep B ≥100 mIU/ml was 98.4% and 99.5% (GMTs 2477 and 2442 mIU/ml), respectively; anti-PRP ≥1.0 μg/ml was 85.2% and 71.1% (GMTs 5.07 and 2.41 μg/ml), respectively. Safety profiles were comparable. There were no vaccine-related serious adverse events. Conclusions Following co-administration with PCV7 the investigational DTaP–IPV–Hep B–PRP-T vaccine was safe and immunogenic. Non-inferiority to DTaP–IPV–Hep B//PRP-T was shown for Hep B and PRP.