Study of Sanofi Pasteur's DTaP-IPV Hep B-PRP-T Combined Vaccine in Infants Who Previously Received Hepatitis B Vaccine

Hepatitis B Clinical Trial

Official title:

Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Three-Dose Primary Series at 2, 3, and 4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821195
• Other study ID #: 2015-A3L35-BR
• Secondary ID: U1111-1143-8177
• Status: Recruiting
• Phase: Phase 3
• First received: June 29, 2016
• Last updated: July 4, 2016
• Start date: April 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: Thiem D Vu, MD., PhD.
• Phone: 84913304649
• Email: vdt[@]nihe.org.vn
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Phase III, open, mono-center study in 177 infants who received a dose of Hep B vaccine at birth or within 1 month after birth.

Infants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine (study vaccine) at 2, 3, and 4 months of age.

All subjects will provide blood samples for immunogenicity assessment at baseline (pre-vaccination) and at 30 days following the third vaccination. Regarding safety, solicited reactions and unsolicited non-serious adverse events (AEs) will be collected up to 7 days and up to 30 days after each vaccination, respectively. Serious adverse events (SAEs) will be collected throughout the study trial (from Visit 1 to Visit 4)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 61 Days to 91 Days

Eligibility

Inclusion Criteria:

• Aged 61 to 91 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 (and by an independent witness if required by local regulations)

• Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures

• Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).

Exclusion Criteria:

• Participation in the 4 weeks preceding the first trial vaccination 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 or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion)

• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion)

• 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 Haemophilus influenzae type b 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 vaccine 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

• History of seizures

• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Vietnam	Thai Binh Preventive Medicine Center	Thai Binh

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Solicited Injection-site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial	Solicited injection-site reactions: Tenderness, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability	Day 0 up to Day 90 post-vaccination	Yes
Secondary	Number of participants with anti Pertussis toxoid and anti Filamentous Hemagglutinin antibody concentrations = Lower Limit of Quantitation (LLOQ) and = 4 x LLOQ at baseline		Day 0 (pre-vaccination)	No
Secondary	Number of participants with = 4-fold and = 2-fold increase in anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations (EU/mL) from pre-dose 1 to one month post-dose 3		Day 30 post-dose 3	No
Secondary	Number of participants with vaccine response for pertussis toxoid and Filamentous Hemagglutinin antigens	Vaccine response defined as post-third dose anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations = 4 x LLOQ if pre-vaccination concentration is <4 x LLOQ or = pre-vaccination concentration if pre- vaccination concentrations = 4 x LLOQ	Day 30 post-dose 3	No
Secondary	Number of participants with anti-Diphtheria antibody concentrations = 0.01 and = 0.1 IU/mL International Units (IU)/mL post-third dose vaccination		Day 30 post-dose 3	No