Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

NCT ID: NCT01948193

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-06-30

Brief Summary

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 (Hexaximâ„¢) 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.

Primary Objective:

• 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.

Secondary Objectives:

• 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.

Detailed Description

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.

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Invasive Hib Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hexaximâ„¢: DTaP-IPV-Hep B-PRP~T combined vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Hexaximâ„¢: DTaP-IPV-Hep B-PRP~T combined vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Hexaximâ„¢

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur SA

Locations

Ludhiana, Punjab, India

Pune, , India

Countries

India

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1127-6936

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2013/09/003997

Identifier Type: REGISTRY

Identifier Source: secondary_id

A3L33

Identifier Type: -

Identifier Source: org_study_id