Overview

This trial is active, not recruiting.

Conditions diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, haemophilus influenzae type b
Treatments dtap-ipv-hep b-prp-t combined vaccine (hexaxim™)
Phase phase 3
Sponsor Sanofi Pasteur, a Sanofi Company
Collaborator National Institute of Hygiene and Epidemiology, Vietnam
Start date April 2015
End date September 2016
Trial size 354 participants
Trial identifier NCT02428491, A3L35, NCT02821195, U1111-1143-8177

Summary

The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth.

Primary Objective:

- To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers

Secondary Objective:

- To evaluate the immunogenicity of the study vaccine one month after the third dose primary series.

- To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3 dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam

- To describe the persistence of all antibodies before receipt of the booster vaccination.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants will receive the primary series vaccinations at 2, 3, and 4 months of age and evaluated for safety and immunogenicity post vaccination.
dtap-ipv-hep b-prp-t combined vaccine (hexaxim™) Hexaxim™
0.5 mL, Intramuscular
(Experimental)
Participants will receive the primary series vaccinations at 2, 3, and 4 months of age and will be evaluated for safety only.
dtap-ipv-hep b-prp-t combined vaccine (hexaxim™) Hexaxim™
0.5 mL, Intramuscular

Primary Outcomes

Measure
Number of Participants Reporting Solicited Injection-site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
time frame: Day 0 up to Day 90 post-vaccination

Secondary Outcomes

Measure
Number of participants with anti Pertussis toxoid and anti Filamentous Hemagglutinin antibody concentrations ≥ Lower Limit of Quantitation (LLOQ) and ≥ 4 x LLOQ at baseline
time frame: Day 0 (pre-vaccination)
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
time frame: Day 21 post-dose 3
Number of participants with vaccine response for pertussis toxoid and Filamentous Hemagglutinin antigens
time frame: Day 21 post-dose 3
Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 and ≥ 0.1 IU/mL International Units (IU)/mL post-third dose vaccination
time frame: Day 21 post-dose 3

Eligibility Criteria

Male or female participants from 61 days up to 91 days old.

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.

Additional Information

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
Description Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's hexavalent vaccine given at 2, 3, and 4 months of age (Primary Series) and then (at 16 to 17 months of age [booster]) to comply with Vietnamese vaccination recommendations.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sanofi.