Key result
The DTaP-IPV//PRP~T vaccine given at 6, 10, and 14 weeks was highly immunogenic, achieving 100% seroprotection for diphtheria, tetanus, and poliovirus, and 94.6% for Haemophilus influenzae type b.
Why the study?
Does the DTaP-IPV//PRP~T combined vaccine given concomitantly with hepatitis B vaccine improve seroprotection and seroconversion rates in healthy infants?
Does the DTaP-IPV//PRP~T combined vaccine given concomitantly with hepatitis B vaccine improve seroprotection and seroconversion rates in healthy infants?
Absolute Event Rate: 94.6% vs 98%
The DTaP-IPV//PRP~T combined vaccine administered at 6, 10, and 14 weeks of age is highly immunogenic and well-tolerated in South African infants.
High seroprotection supports DTaP-IPV//PRP~T schedule evaluation in South African infants; leaves open randomized efficacy and durability data.
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.
No takes yet. Share an insight, caveat, or question.
Madhi et al. (2011) studied Healthy infants (n=212). DTaP-IPV//PRP~T combined vaccine (Pentaxim) and monovalent hepatitis B vaccine vs. Historical reference (same vaccine at 2, 3, and 4 months of age) was evaluated on Seroprotection rate for Haemophilus influenzae type b (anti-PRP ≥0.15 µg/ml) 1 month after the third dose (95% CI 90.6-97.3). The DTaP-IPV//PRP~T vaccine given at 6, 10, and 14 weeks was highly immunogenic, achieving 100% seroprotection for diphtheria, tetanus, and poliovirus, and 94.6% for Haemophilus influenzae type b.
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: