Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02428491
• Date of registration: 23/04/2015
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 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
• Scientific 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
• Date of first enrolment: April 20, 2015
• Target sample size: 354
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02428491
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur SA

Key inclusion & exclusion criteria

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.



Age minimum: 61 Days
Age maximum: 91 Days
Gender: All

Health Condition(s) or Problem(s) studied

Diphtheria

Haemophilus Influenzae Type b

Pertussis

Tetanus

Hepatitis B

Poliomyelitis

Intervention(s)

Biological: Hexaxim®

Primary Outcome(s)

Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions [Time Frame: Within 7 days after vaccination]

Secondary Outcome(s)

Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (NCT01105559) [Time Frame: Day 90 (1 month after third dose)]

Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1 [Time Frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)]

Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1 [Time Frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)]

Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1 [Time Frame: Day 90 (1 month after third dose)]

Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort [Time Frame: Day 90 (1 month after third dose)]

Secondary ID(s)

A3L35

U1111-1143-8177

Source(s) of Monetary Support

Please refer to primary and secondary sponsors