Key result
The hexavalent DTwP-IPV-HB-PRP~T vaccine was noninferior to separate vaccines for all antigens, with similar rates of solicited adverse events (99.1% vs 98.3%).
Why the study?
Does a fully liquid hexavalent DTwP-IPV-HB-PRP~T vaccine provide noninferior immunogenicity and similar safety compared to separate DTwP-HB-PRP~T, bOPV, and IPV vaccines in healthy infants?
RCT (n=459)
Open-label
randomized
Does a fully liquid hexavalent DTwP-IPV-HB-PRP~T vaccine provide noninferior immunogenicity and similar safety compared to separate DTwP-HB-PRP~T, bOPV, and IPV vaccines in healthy infants?
The fully liquid hexavalent DTwP-IPV-HB-PRP~T vaccine is highly immunogenic and safe when co-administered with rotavirus and PCV13 vaccines in infants.
Supports hexavalent vaccine adoption to simplify infant schedules; extends RCT evidence for co-administration with rotavirus and PCV13.
BACKGROUND: This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)- Haemophilus influenzae b (PRP-T) vaccine compared to licensed DTwP-HB-PRP~T, IPV, and bivalent oral poliovirus (bOPV) vaccines following co-administration with other pediatric vaccines [pneumococcal conjugate vaccine (PCV13) and rotavirus vaccine]. METHODS: Phase III, randomized, open-label study in Thailand. Healthy infants received DTwP-IPV-HB-PRP~T at 2, 4 and 6 months of age (N = 228), or DTwP-HB-PRP~T and bOPV (2, 4 and 6 months of age) and IPV (4 months of age) (N = 231). All participants received PCV13 (2, 4 and 6 months of age) and rotavirus vaccine (2 and 4 months of age). Immunogenicity for all antigens was assessed using validated assays, and noninferiority post-third dose was evaluated for anti-D, anti-T, anti-pertussis [anti-pertussis toxin (anti-PT) and anti-fimbriae 2/3 (anti-FIM)], anti-polio 1, 2, 3, anti-HB, and anti-PRP~T. Safety was assessed using parental reports. RESULTS: Noninferiority was demonstrated for each antigen, and overall noninferiority of DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV was concluded. Similarity in each group was observed for the GMC ratio for antirotavirus antibodies (20.9 and 17.3, respectively) and anti-PCV13 antibodies (range: 8.46-32.6 and 7.53-33.1, respectively). Two serious adverse events were related to DTwP-IPV-HB-PRP~T (febrile convulsion and acute febrile illness) and 1 was related to DTwP-HB-PRP~T+bOPV+IPV (febrile seizure), but overall there were no safety concerns with similar rates of participants experiencing solicited (99.1% and 98.3%) and unsolicited (19.3% and 19.5%) adverse events in each group. CONCLUSIONS: This study confirmed the suitability of DTwP-IPV-HB-PRP~T primary series vaccination in combination with rotavirus and PCV13 vaccines.
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Sanchez et al. (2023) conducted an RCT in Healthy infants (n=459). DTwP-IPV-HB-PRP~T vaccine vs. DTwP-HB-PRP~T, bOPV, and IPV vaccines was evaluated on Immunogenicity (anti-D, anti-T, anti-pertussis, anti-polio 1, 2, 3, anti-HB, and anti-PRP~T) post-third dose. The hexavalent DTwP-IPV-HB-PRP~T vaccine was noninferior to separate vaccines for all antigens, with similar rates of solicited adverse events (99.1% vs 98.3%).
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