DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

Hepatitis B Clinical Trial

Official title:

Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094833
• Other study ID #: A3L31
• Secondary ID: U1111-1127-6896
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2014
• Last updated: April 25, 2017
• Start date: March 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative.

Primary Objective

• To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines.

Secondary Objectives:

• To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines.

• To study the safety after each and any dose of vaccines administered in the two vaccination schemes

Description:

Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 6 Months

Eligibility

Inclusion Criteria:

• Aged 30 to 40 days on the day of the first study visit

• Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg

• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative

• Participant 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 the maternal blood sample is available)

• Have received one documented dose of Hep B vaccine at birth according to the national recommendations.

Exclusion Criteria:

• Participation 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 any trial vaccination (except Bacille Calmette Guerin (BCG) vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination

• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either 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)

• Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity

• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically, serologically, or microbiologically

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of 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 (temperature = 38.0°C). A prospective participant 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 or employee with direct involvement in the proposed study

• History of seizures.

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b Infection
• Hepatitis
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DTaP-IPV-Hep B-PRP~T combined vaccine
0.5 mL, Intramuscular
• DTaP-IPV//PRP~T and Hepatitis B vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with anti-Diphtheria antibody concentrations = 0.01 International Units (IU)/mL	Anti-Diphtheria antibodies will be measured by a toxin neutralization test	1 month post third vaccination
Primary	Number of participants with anti-Tetanus antibody concentrations = 0.1 International unit (IU)/mL	Anti-Tetanus antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).	1 month post third vaccination
Primary	Number of participants with = 4 fold increase in anti-PT and anti-FHA antibody concentrations (EU/mL) from 1 month pre-dose 1 to 1 month post-dose 3	Anti-PT and anti-FHA antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).	I month post dose 3
Secondary	Number of participants with anti-Diphtheria antibody concentrations = 0.01 IU/mL and = 0.1 IU/mL International Units (IU)/mL	Anti-Diphtheria antibodies will be measured by a toxin neutralization test	Day 0 Pre-vaccination
Secondary	Number of participants with anti-Hepatitis B antibody concentrations = 10 mIU/mL international unit (IU)/mL	Anti-Hepatitis B antibodies will be measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System using chemiluminescence detection technology	Day 0 Pre-vaccination
Secondary	Number of participants with anti Diphtheria antibody concentrations = 0.1 IU/mL International Units (IU)/mL	Anti-Diphtheria antibodies will be measured by a toxin neutralization test	1 month post third vaccination
Secondary	Number of participants reporting solicited injection site and solicited systemic reactions, unsolicited adverse events, and serious adverse events following vaccination with either DTaP-IPV-Hep B-PRP~T combined vaccine or Pentaxim™ and Euvax B® vaccine	Solicited injection site reactions Tenderness, Erythema, and Swelling. Solicited systemic reactions Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.	Day 0 and up to Day 180 post-vaccination
Secondary	Number of participants with response to vaccine Pertussis toxoid (PT) and Filamentous Haemagglutinin (FHA) antigens	Vaccine response defined as: Post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL = 4 x Lower Limit of Quantitation (LLOQ) if pre-vaccination concentration is < 4 x LLOQ or = pre-vaccination concentration if pre-vaccination concentrations = 4 x LLOQ	1 month post third vaccination

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