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Objective: To assess the immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Hib polysaccharide-conjugate vaccine booster., Design, Setting and Participants: A DTaP-IPV//PRP~T vaccine (Pentaxim, a Sanofi Pasteur AcXim family vaccine) was given to 182 healthy children in South Africa at 18 - 19 months of age following priming with the same vaccine plus a monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age. Outcome measures. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titres (GMTs) and concentrations (GMCs) were assessed before, and 1 month after, the booster dose. Safety was assessed using parental reports., Results: One month after primary vaccination, at least 94.3% of participants were seroprotected against tetanus (≥ 0.01 IU/ml), diphtheria (≥ 0.01 IU/ml), poliovirus (≥ 8 1/dil) and Haemophilus influenzae type b (Hib) infection (≥ 0.15 µg/ml). Before the booster dose, the SP rates ranged from 65.7% to 100%. One month after the booster dose, SP rates were 97.7% for Hib (anti-PRP titre 1.0 μg/ml), 100.0% for diphtheria (≥ 0.1 IU/ml) and 100% for tetanus (≥ 0.1 IU/ml) and poliovirus types 1, 2, 3 (≥ 8 1/dil). At least 95.7% of participants had 4 fold post-booster increases in anti-pertussis antibody titres. GMTs increased from 11.21 to 465.51 EU/ml and from 12.89 to 520.35 EU/ml for anti-PT and anti-FHA respectively. Anti-PRP GMT increased from 0.35 to 47.01 μg/ml. The DTaP-IPV//PRP~T vaccine booster was well tolerated, with fever ≥ 39.0°C in only 1.7% of participants., Conclusions: Antibody persistence following priming was satisfactory. The pentavalent DTaP-IPV//PRP~T vaccine booster was highly immunogenic and well tolerated.

Objective: To assess the immunogenicity and safety data for a pentavalent combination vaccine containing acellular pertussis, inactivated poliovirus, and Haemophilus influenzae (Hib) polysaccharide-conjugate antigens., Methods: A DTaP-IPV//PRP T vaccine (Pentaxim) was given at 6, 10 and 14 weeks of age to 212 infants in South Africa. Monovalent hepatitis B vaccine was given concomitantly. Immunogenicity was assessed using seroprotection and seroconversion rates; safety was assessed by monitoring for solicited injection site and systemic adverse events, and follow-up monitoring for unsolicited adverse events and serious adverse events., Results: Immunogenicity was high for each vaccine antigen, and similar to a reference study done in France using a similar (2, 3 and 4 months of age) administration schedule. After the third dose, 94.6% of participants had anti-PRP > or = 0.15 microg/ml. The anti-PRP geometric mean antibody titre (GMT) was 2.0 microg/ml. The seroprotection rates for diphtheria and tetanus (> or = 0.01 IU/ml), poliovirus types 1, 2 and 3 (> or = 8 1/dil U) and hepatitis B were all 100%. Anti-polio GMTs were very high, 1 453, 1 699 and 2 398 (1/dil U) for types 1, 2 and 3, respectively. The seroconversion/vaccine response rates to pertussis antigens (4-fold increase in antibody concentration) were 97.5% for PT and 83.9% for FHA., Conclusions: The DTaP-IPV//PRP T vaccine was highly immunogenic at 6, 10 and 14 weeks of age in infants in South Africa, was compatible with the monovalent hepatitis B vaccine, and was well tolerated.