None listed
Conditions
Interventions
Intervention1: new fully liquid hexavalent DTwP-HepB-Hib-IPV vaccine (EasysixTM, Panacea Biotec Ltd.): Three doses(0.5 ml each) at 6, 10 and 14 weeks of age.
Control Intervention1: pentavalent DTwP-He
sanofi pasteur India Pvt. Ltd.): Three doses at 6, 10 and 14 weeks of age.
Sponsors
Panacea Biotec Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newborn infants (subject age upto 27 days) whose parents/LAR are willing to give written informed consent prior to the study entry. 2. Born at full term pregnancy (more than equal to 37 weeks) with a birth weight more than equal to 2.5 Kg. 3. Infants with good health as determined by Medical history, Physical examination and Clinical judgment of the investigator 4. Infants who are not seroprotected against diphtheria, tetanus, pertussis, Hepatitis B, H. influenzae type b or Polio by virtue of previous immunization and/or antigen exposure. 5. Judged to be able to attend all scheduled study visits and to comply with trial procedures.
Exclusion criteria
Exclusion criteria: 1. Parents or legal guardians are unwilling or unable to give written informed consent for infant's participation in the study. 2. Newborns requiring hospitalization for more than 1 day. 3. Known history of HBsAg positivity in mother. 4. History of immunization with zero dose of OPV, or Hepatitis B. 5. Subject is less than 6 weeks or more than 7 weeks of age. 6. Infants having history of previous immunization or infection with one of the vaccine constituents. 7. 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. 8. History of household contact and/or intimate exposure to an individual with suspected poliomyelitis. 9. Fever > 38°C in past 3 days 10. Any evidence of acute illness or infection within past 7 days. 11. Planned or elective surgery during the course of the study. 12. Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or received immunosuppressive therapy within 1 month prior to study entry (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 13. Infants who have received any blood products, cytotoxic agents or radiotherapy. 14. Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. 15. 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) 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. 16. Any evidence of thrombocytopenia or a bleeding disorder. 17. Infants who have participated in another trial of an investigational agent within 30 days of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMTs and seroprotection against diphtheria, tetanus, Hepatitis B, Hib, and Polio virus type 1, type 2 and type 3 and seroresponsiveness against pertussisTimepoint: Serum Antibody titres pre vaccination and one month after completion of three dose primary vaccination series. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Events (SAEs)Timepoint: during the entire study period;Solicited symptoms (local and general)Timepoint: During the 3 day follow-up period after each vaccine dose;unsolicited adverse events (AEs)Timepoint: 28 day (Day 0-28) follow-up period after each dose of study vaccine | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Panacea Biotec Limited
Outcome results
None listed