Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: September 18, 2013
Last updated: March 1, 2015
Last verified: March 2015
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:
| 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.
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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
||March 1, 2015
||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 March 31, 2015
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
DNA Virus Infections
Digestive System Diseases
Gram-Negative Bacterial Infections
Hepatitis, Viral, Human
Nervous System Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Spinal Cord Diseases