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

NCT01948193 | Completed Phase 3 Results

• 3 other identifiers: A3L33U1111-1127-6936CTRI/2013/09/003997
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

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 (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. 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.

Conditions

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

Keywords

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; DTaP IPV-Hep B-PRP~T combined vaccine (Hexaxim™)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

  Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.

  Pre-dose 1 to one month post-dose 3

• Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

  Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was \< 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.

  Pre-dose 1 to one month post-dose 3

Secondary Outcomes (4)

• Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

  Pre-dose 1 to one month post-dose 3

• Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

  Pre-dose 1 to one month post-dose 3

• Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth

  Pre-dose 1 to one month post-dose 3

• Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth

  Within 7 days after each vaccine injection

Study Arms (1)

Study Group

EXPERIMENTAL

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

Interventions

Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Hexaxim™

Study Group

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
• History of seizures.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Ludhiana, Punjab, 141008, India

Location

Unknown Facility

Pune, 411043, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Interventions

DTaP-IPV-HB-PRP-T vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 20, 2015
• Results First Posted: September 25, 2015

Record last verified: 2015-09

Locations

IN (2)