An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib-IPV vaccine (EasyfourPolTM, Panacea Biotec Ltd.) with QuadrovaxTM (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Panacea Biotec Ltd
- Enrollment
- 244
- Locations
- 4
- Primary Endpoint
- Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-Hib-IPV vaccine in the two treatment groups.
Study Overview
Brief Summary
The study will enroll Infants 6-10 weeks of age. Subjects will be randomized to receive either 3-dose primary vaccination series of Fully liquid pentavalent DTwP-Hib-IPV vaccine EasyfourPolTM, Panacea Biotec Ltd.) of Panacea Biotec Ltd. as a single intramuscular injection or QuadrovaxTM (Tetravalent DTwP /Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) as two separate injections intramuscularly. The vaccinations will be done at 0, 4 and 8 weeks of enrolment. Local and systemic reactions will be observed on each vaccination day (up to 30 minutes) and on 4 subsequent days (day 0-3) after each dose. Adverse reactions will also be monitored for 28 days after each vaccination. Blood sample will be obtained from subjects at visit 1(before first vaccination and at visit 4 (Follow up visit) for estimation of Anti-diphtheria, Anti-tetanus, Anti-PRP, Anti-pertussis, Anti pertussis toxin antibodies and neutralizing antibodies against Polio. The samples will be sent to Panacea’s central laboratory for analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 42.00 Day(s) to 70.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Infants 6-10 weeks of age, whose parents/LAR are willing to give written informed consent prior to the study entry.
- •2.Infants with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator 3.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
Exclusion Criteria
- •1.Infants weighing  3.3 Kg at the time of enrollment.
- •2.Infants less than 6 weeks or more than 10 weeks of age.
- •3.Infants having history of immunization with vaccine other than zero polio, BCG and birth dose of HepB.
- •4.Infants with history of infection potentially related to any of the agents targeted by the DPT-Hib-IPV vaccine 5.Presence of evolving or changing neurological disorder or Infants with history of seizures before receiving the vaccine.
- •Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
- •6.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
- •Fever >38o C in past 3 days 8.Any evidence of acute illness or infection within past 7 days.
- •9.Planned or elective surgery during the course of the study.
- •10.Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 11.Infants who have received any blood products, cytotoxic agents or radiotherapy.
- •12.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •13.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) or major congenital defects, such that it would endanger the volunteer’s well being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •14.Any evidence of thrombocytopenia or a bleeding disorder.
- •15.Infants who have participated in another trial or received of an investigational agent within 30 days of enrolment.
Outcomes
Primary Outcomes
Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-Hib-IPV vaccine in the two treatment groups.
Time Frame: Day 0 and Day 84
Secondary Outcomes
- •Incidence of solicited local and systemic reactions during 4 days of each vaccine dose (day 0-3).(•Incidence of unsolicited adverse events up to 4)