A Phase 3 clinical study of 6-in-1 vaccine (SHAN6â?¢) to check immunity equivalence of 3 different batches and immunity non-inferiority to 5-in-1 vaccine (SHAN 5Â®) PLUS SHANIPVâ?¢, when given as 3 doses schedule at 6-8, 10-12 and 14-16 weeks of age along with Oral Rotavirus Vaccine

Immune Lot-to-Lot Consistency and Non-Inferiority of SHAN6â?¢ Vaccine in Comparison to SHAN 5Â® + SHANIPVâ?¢ When Administered as Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants, Concomitantly with Oral Rotavirus Vaccine

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017155

Enrollment

1280

Registered

2019-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SHAN6â?¢ (DTwP-HepB-Hib-IPV): 0.5 mL administered intramuscularly, 3 doses at an interval of 4 weeks in between Control Intervention1: SHAN 5Â® (DTwP-HepB-Hib): 0.5 mL administered int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants between 6-8 weeks of age (42 to 56 days, both days inclusive) 2. Infants, born at full term of pregnancy (>= 37 weeks) with a birth Weight >= 2.5 kg. 3. Infants who have received the birth dose of Oral Polio Vaccine (OPV), Hep B vaccine and Bacillus Calmette-GuÃ©rin vaccine (BCG) vaccine. 4. Informed consent form (ICF) signed by one or both parents or by the LAR as per local requirements. 5. Subjects and parents/LAR are able to attend all scheduled visits

Exclusion criteria

Exclusion criteria: 1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion. 2. Known systemic hypersensitivity to any of the vaccine components 3. Chronic illness at a stage that could interfere with trial conduct or completion, 4. Blood or blood-derived products received in the 30 days 5. Documented history of diphtheria, pertussis, tetanus, Haemophilus influenzae type b invasive disease, hepatitis B, poliomyelitis or rotavirus infection. 6. Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity. 7. Known thrombocytopenia 8. Bleeding disorder or receipt of anticoagulants 9. Moderate or severe acute illness/infection on the day of vaccination 10. Identified as a natural or adopted child of the Investigator, relatives or employee. 11. History of seizures or encephalopathy. 12. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, 13. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. 14. Planned receipt of any other vaccine within the period from 7 days before to 7 days after each trial vaccination. 15. Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) disease, Haemophilus influenzae type b infection poliomyelitis (except the OPV) or rotavirus, apart from trial vaccines 16. History of intussusception.

Design outcomes

Primary

Measure	Time frame
Immunogenicity (Seroprotection rates/ GMCs)Timepoint: Baseline and 28 days post-Dose 3	—

Secondary

Measure	Time frame
Immunogenicity (Descriptive)Timepoint: Baseline and 28 days post-Dose 3;SafetyTimepoint: Immediate systemic adverse events with in 30 min, Solicited reactions with in 7 days and unsolicited events within 28 days of each vaccination, SAEs and AESI through out the subject participation	—

Countries

India

Contacts

Public ContactDr Somnath Mangarule

Shantha Biotechnics Pvt Limited(a Sanofi Company)

Somnath.Mangarule@sanofi.com04066301502

Outcome results