None listed
Conditions
Interventions
Intervention1: Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (EasyfiveTM, Panacea Biotec Ltd.): 0.5 ml of vaccine at 2, 4, 6 months of age and a booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec
Sponsors
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants of 2 months (+2 weeks) of age whose parents/LAR 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. Infants who are not seroprotected against Diphtheria, tetanus, pertussis, Hepatitis B or H. influenzae type b by virtue of previous immunization and/or antigen exposure. â??Zero doseâ?? of Hepatitis B vaccine will be allowed for subjects who are enrolled in Thailand.
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. â??Zero doseâ?? of Hepatitis B vaccine will be allowed for subjects who are enrolled in Thailand. 3. Known HBsAg positivity in mother. 4. Presence of evolving or changing neurological disorder. 5. 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. Fever >= 38°C (Axillary temperature >= 37°C) in past 3 days. 7. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days. 8. Planned or elective surgery during the course of the study. 9. Infants born before the 37th week of gestation. 10. Birth weight less than 2.5 kg. 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. Any history suggestive of thrombocytopenia or a bleeding disorder. 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. Infants with any serious chronic disease such as cardiac, autoimmune disease or insulin dependent diabetes or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives. 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 |
|---|---|
| â?¢ Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, 1 month after three dose vaccination series of DTwP-HB-Hib vaccine in each of the two treatment groups.Timepoint: â?¢ Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, 1 month after three dose vaccination series of DTwP-HB-Hib vaccine in each of the two treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Proportion of subjects achieving seroprotection against all three serotypes of Polio one month after concomitant administration of tOPV vaccine at 2, 4 and 6 months of age. â?¢Seroprotection, GMT and maintenance of seroprotection at 18 months of age for Hepatitis B will be compared among the subjects who have received three doses versus four doses of Hepatitis B vaccine, as primary vaccination schedule. Timepoint: .Seroprotection against all three serotypes of Polio virus, one month after concomitantly administered tOPV vaccine (at 2, 4 and 6 months of age) will also be estimated at visit 1(prior to immunization) and visit 4 (one month after completion of primary immunization series). .Zero doseâ?? of Hepatitis B vaccine will be allowed for subjects who are enrolled in Thailand;â?¢Proportion of subjects achieving seroprotection against diphtheria, tetanus and Hib and seroresponsiveness against pertussis one month after booster vaccination. â?¢Mean Concentrations or Geometric Mean Titres (GMTs) for Anti-diphtheria, Anti-tetanus, Anti-PRP, anti-pertussis toxoid (anti-PT), and IgG Bordetella pertussis antibodies one month after booster vaccination. Timepoint: Blood sample will be collected at 1 month following booster immunization;Immunological Endpoint â?¢Mean Concentrations or Geometric Mean Titres (GMTs) for Anti-diphtheria, Anti-tetanus, Anti-HBs, Anti-PRP, anti-pertussis toxoid (anti-PT), and IgG Bordetella pertussis antibodies one month after completion of primary vaccination series. Timepoint: primary vaccination series comprises of vaccination at 2,4,6 months of age;Immunological Endpoint â?¢Proportion of subjects maintaining seroprotective levels of antibodies against diphtheria, tetanus, Hepatitis B and Hib and seroresponsiveness against pertussis, at 18 months of age (before booster vaccination) in the treatment groups.Timepoint: booster dose of DTwP-Hib (EasyfourTM, Panacea Biotec Ltd.)will be administered to all subjects at 18 months of age.; | — |
Countries
Chile, Egypt, Thailand
Contacts
Public ContactDr Arani Chatterjee
Panacea biotec ltd
Outcome results
None listed