A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants

ABSTRACT

An open-label, randomized, multi-center trial was conducted to compare the immunogenicity and safety of an indigenously developed tetravalent DTwP-Hib vaccine, Easyfour®-TT with a commercially available vaccine, Quadrovax®. A total of 244 infants in good health, aged 6–10 weeks, were randomized in a 1:1 allocation to receive three doses of the test or comparator vaccine. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody response against the vaccine antigens; safety was evaluated in terms of local and systemic reactions (solicited and unsolicited) reported during the trial. Similar levels of seroprotection/seroresponse were achieved, 4 weeks after receiving 3 doses of Easyfour®-TT and Quadrovax®, and the antibody response of Easyfour®-TT was found non-inferior to Quadrovax®, against all four vaccine antigens. Both vaccines were well tolerated and had similar reactogenicity profiles, with a significantly lower occurrence of local (redness at injection site) and systemic reactions (irritability post-vaccination) with Easyfour®-TT vaccine as compared to Quadrovax® (p < 0.05). All adverse events resolved completely with no sequelae. All through the study, only one serious adverse event was observed that completely resolved upon treatment and was deemed unrelated to the vaccine administered. This study demonstrated that Easyfour®-TT vaccine was safe and immunogenic.

Clinical trial registration number: CTRI/2014/12/005326 (registered with the Clinical Trial Registry of India (CTRI)).

KEYWORDS:

• combination
• DTwP-Hib
• Easyfour®-TT
• seroprotection
• tetravalent
• vaccine

Disclosure of potential conflicts of interest

LM, AS, SK, CP, BB, AG, DC and SP are employees of Panacea Biotec. Drs. PV, AD, TKS, SKL had no financial interests in the vaccine or the manufacturer but received research funding to undertake the study. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Acknowledgments

The authors would like to thank the volunteers who participated in the trial and their families for their support Satyender Kumar, member of clinical data management team, principal investigators and their staff who oversaw the conduct of the study at their respective sites: P. Venugopal, King George Hospital, Visakhapatnam, Ashish Dhongade, Sant Dnyaneshwar Medical Education Research Centre, Pune, Tapas Kumar Sabui, Calcutta Medical College, Kolkata, Sanjay Kewalchand Lalwani, Bharti Vidyapeeth Medical College and Hospital, Pune.

Funding

This work was funded by Panacea Biotec Limited.

Author contributions

LM, SS, SP and CP conceived and designed the study. LM, AS, BB, SK and CP contributed to the analysis and interpretation of data. All the authors were involved in the initial drafting of the manuscript. LM, AS, SS and BB were involved in the finalization of the manuscript.