Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Verified August 2014 by Sanofi
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: September 18, 2013
Last updated: August 26, 2014
Last verified: August 2014
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India.
- To evaluate the immunogenicity of the study vaccine in terms of seroprotection [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one month after the third dose.
- To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose.
- To describe the safety after each and any doses of the study vaccine.
Invasive Hib Infections
Biological: Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
Primary Outcome Measures:
- Summary of levels of antibodies to the vaccine antigens following 3 doses of DTaP-IPV-Hep B-PRP~T, Sanofi Pasteur's hexavalent vaccine [ Time Frame: Day 30 (post 3rd vaccination) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events after booster administration of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine. [ Time Frame: Day 0 to up to 3 months post-vaccination ] [ Designated as safety issue: No ]
Solicited injection site: Tenderness, Redness, and Swelling: Solicited Systemic Reactions: Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Unsolicited averse events including serious adverse events.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: Study Group
Participants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine (investigational vaccine) at 6, 10 and 14 weeks of age.
Biological: Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
Other Name: Hexaxim™
All participants will receive a total 4 doses of Hep B, i.e. one dose of Hep B monovalent vaccine given at birth followed by 3 doses of Sanofi Pasteur's hexavalent vaccine given at 6, 10 and 14 weeks of age in the context of the study. Participants and parents will attend four clinic visits; the expected participation in the study is approximately 3 months.
|Ages Eligible for Study:
||6 Weeks to 8 Weeks
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Aged between 42-56 days (6 to 8 weeks) on the day of inclusion
- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- Informed consent form signed by the parent(s) or any other legally acceptable representative
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during last trimester of pregnancy available)
- Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV) from birth as per national recommendations.
- Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacillus Calmette-Guerin [BCG] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another vaccine
- Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically)
- Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
- 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
- Known thrombocytopenia, as reported by the parent/legally acceptable representative
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- In an emergency setting, or hospitalized involuntarily
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided)
- Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
- History of seizures.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948193
|Ludhiana, Punjab, India, 141008 |
|Pune, India, 411043 |
Sanofi Pasteur, a Sanofi Company
||Sanofi Pasteur SA
No publications provided
||Sanofi ( Sanofi Pasteur, a Sanofi Company )
History of Changes
|Other Study ID Numbers:
||A3L33, U1111-1127-6936, CTRI/2013/09/003997
|Study First Received:
||September 18, 2013
||August 26, 2014
||India: Drugs Controller General of India
Keywords provided by Sanofi:
DTaP IPV-Hep B-PRP~T combined vaccine (Hexaxim™)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Gram-Positive Bacterial Infections
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Gram-Negative Bacterial Infections
Respiratory Tract Infections