None listed
Conditions
Interventions
Intervention1: Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (MyFiveTM, Panacea Biotec Ltd.): three doses (0.5 Ml each)at 6,10 and 14 weeks of age by intramuscular route
Control Intervention1: Pentav
Sponsors
PANACEA BIOTEC LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants of 6-10 weeks of age whose parents/LAR give written informed consent/oral witnessed consent prior to the study entry. 2. Infants with good health as determined by: ? Medical history ? Physical examination ? Clinical judgment of the investigator 3. Infants who are not seroprotected against Diptheria, tetanus, pertussis, Hepatitis B or H. influenzae type b by virtue of previous immunization and/or antigen exposure
Exclusion criteria
Exclusion criteria: 1. The parents or LAR are unwilling or unable to give written informed consent to participate in the study 2. Infants having history of previous immunization or infection with one of the vaccine constituents. 3. Known HBsAg positivity in mother. 4. 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. 5. Fever 38°C in past 3 days 6. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days. 7. Planned or elective surgery during the course of the study. 8. Infants who have presented a previous disease potentially related to any of the agents targeted by the DPT-Hep B-Hib vaccine 9. Infants born before the 37th week of gestation 10. Birth weight less than 2.5 kg at birth or weight 3.3Kg at the time of screening. 11. Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 12. Infants who have received any blood products, cytotoxic agents or radiotherapy. 13. Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. 14. Infants with 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 with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives. 15. Any evidence of thrombocytopenia or a bleeding disorder. 16. Infants who have participated in another trial of an investigational agent within 30 days of enrolment. 17. Infants whose families are planning to leave the area of the study site before the end of the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMTs and Seroprotection agaisnt diphtheria, tetanus, Hib,Hep B and seroresponsiveness against pertussisTimepoint: GMTs and Seroprotection agaisnt diphtheria, tetanus, Hib,Hep B and seroresponsiveness against pertussis | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of solicited adverse events within 3 days of each vaccine dose (day 0-3). â?¢ Incidence of unsolicited adverse events up to 4-5 weeks after last vaccination. â?¢ Incidence of SAE during the entire study period. â?¢ Seroconversion against each of the 3 polio serotypesTimepoint: .28 day (Day 0-28) follow-up period after each dose of study vaccine. 2.During the entire study period 3.During the 3 day follow-up period after each vaccine dose . â?¢ Seroconversion against each of the 3 polio serotypes prevaccination and 28 days post 3 dose vaccination | — |
Countries
India
Contacts
Public ContactArani Chatterjee
Outcome results
None listed