None listed
Conditions
Interventions
Intervention1: Pentavalent DTwP-HepB-Hib vaccine (Shan5): Dose: 0.5ml, 3 dose series (at 6-8, 10-12 and 14-16 weeks of age) in infants and Single dose (at 12 to 24 months of age) in Toddlers. Route:
Sponsors
Shantha Biotechnics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: For Infants (Stage 1): 1. Infants between 6-8 weeks of age on the day of enrollment. 2. Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg 3. Informed consent form signed by the parent or by the legally acceptable representative (LAR). 4. Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures. For Toddlers (Stage 2): 1. Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5�® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial. 2. Informed consent form signed by the parent or by the LAR. 3. Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period 2. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine). 3. Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV. 4. For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine. 5. For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine. 6. Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial. 7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy. 8. History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections. 9. Known personal or maternal history of HIV or hepatitis B seropositivity. 10. Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances. 11. Known thrombocytopenia. 12. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination. 13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. 14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion. 15. Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study. 16. Subject with definite seizure disorder and getting anticonvulsant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responsesTimepoint: Baseline; 28 days after Dose-3 in infants | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity in terms of Seroprotection/seroresponse rates/GMCs for D,T,wP,HepB and Hib antigensTimepoint: Baseline; 28 days post Dose-3 in infants and 28 days after single dose in toddlers;Safety after each and after any study vaccine dose, as applicable.Timepoint: Immediate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination. | — |
Countries
India
Contacts
Public ContactDr Naveena Aloysia Dcor
Shantha Biotechnics Pvt Ltd
Outcome results
None listed