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ABSTRACT
We conducted 3 phase III, randomized, open-label, clinical trials assessing the safety, reactogenicity (all studies), immunogenicity (Primary vaccination study) and persistence of immune responses (Booster study) to the combined diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Chinese infants and toddlers.
In the Pilot study (NCT00964028), 50 infants (randomized 1:1) received 3 doses of DTPa-IPV/Hib at 2–3–4 (Group A) or 3–4–5 months of age (Group B). In the Primary study (NCT01086423), 984 healthy infants (randomized 1:1:1) received 3 doses of DTPa-IPV/Hib at 2–3–4 (Group A) or 3–4–5 (Group B) months of age, or concomitant DTPa/Hib and poliomyelitis (IPV) vaccination at 2–3–4 months of age (Control group); 825 infants received a booster dose of DTPa/Hib and IPV at 18–24 months of age (Booster study; NCT01449812).
In the Pilot study, unsolicited symptoms were more frequent in Group A (16 versus 1 infant; mostly upper respiratory tract infection and pyrexia); this observation was attributed to an epidemic outbreak of viral infections. Non-inferiority of 3-dose primary vaccination with DTPa-IPV/Hib over separately administered DTPa/Hib and IPV was demonstrated for Group A (primary objective). Similar antibody concentrations were observed in all groups, except for anti-polyribosyl-ribitol phosphate and anti-poliovirus types 1–3 which were higher in DTPa-IPV/Hib recipients. Protective antibody levels against all vaccine antigens remained high until booster vaccination. Three-dose vaccination with DTPa-IPV/Hib had a clinically acceptable safety profile.
Abbreviations
| AE | = | adverse event |
| ATP | = | according-to-protocol |
| CI | = | confidence interval |
| DT | = | diphtheria toxoid |
| DTPa | = | combined diphtheria, tetanus and acellular pertussis vaccine |
| DTPa-IPV/Hib | = | combined pentavalent vaccine against diphtheria, tetanus, pertussis, poliomyelitis and Hib |
| ED | = | effective dose |
| ELISA | = | enzyme-linked immunosorbent assay |
| EPI | = | National Expanded Program on Immunization |
| FHA | = | filamentous hemagglutinin |
| GMC | = | geometric mean concentration |
| GMT | = | geometric mean titer |
| Hib | = | Haemophilus influenzae type b |
| IPV | = | inactivated poliovirus vaccine |
| IU | = | International units |
| OPV | = | oral poliovirus vaccine |
| PRN | = | pertactin |
| PRP | = | polyribosyl-ribitol phosphate |
| PT | = | pertussis toxoid |
| SAE | = | serious adverse event |
| TT | = | tetanus toxoid |
| TVC | = | total vaccinated cohort |
| UL | = | upper limit |
| WHO | = | World Health Organization |
Disclosure of potential conflicts of interest
NK, OVDM and NM are employees of GSK group of companies; HHH and DA are former employees of GSK group of companies. HHH, OVDM and NM report ownership of restricted shares. All other authors have no conflict of interest to disclose.
Acknowledgments
The authors would like to acknowledge Richard Zhao (GSK, Beijing, China) for critical review of the draft and support provided during manuscript development. The authors also acknowledge Priya D'Silva and Rashmi Jain (GSK, Bangalore, India) for their support in conducting the statistical analysis. Writing support was provided by Urszula Miecielica (XPE Pharma & Science C/O GSK group of companies) and editorial support and publication management was provided by Iudit-Hajnal Filip (XPE Pharma & Science C/O GSK group of companies).
Funding
GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analyses. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and publication of this manuscript.
Contributorship
OVDM and RCL were involved in conception and design of the work; OVDM, Yanping L, QY, Yanan L, XM, YPL, RCL, CL, HZ and XC were involved in data acquisition or assembling; HHH, OVDM, RCL, NK, DA and NM performed data interpretation and analysis. All authors reviewed the manuscript critically and approved the final version; all authors take accountability for all aspects of the work.