Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT01983540
• Date of registration: 07/11/2013
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
• Scientific title: Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
• Date of first enrolment: October 2013
• Target sample size: 558
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01983540
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Colombia, Costa Rica

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit

- Informed consent form has been signed and dated by the parent(s) or other legally
acceptable representative (and by independent witness/es 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

- Receipt of primary vaccination with 3 doses of investigational vaccines during the
primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa,
concomitantly administered with Prevenar [PCV7] and Rotarix) and a booster dose
during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly
administered with Prevenar [PCV7]).

Exclusion Criteria:

- Participation at the time of study enrollment (or in the 4 weeks preceding the first
trial visit) or planned participation during the present trial period in another
clinical trial investigating a vaccine, drug, medical device, or medical procedure

- Incomplete primary and booster immunization at trial A3L24 and A3L27

- Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned
receipt of any vaccine in the 4 weeks preceding the second trial visit

- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis
B, or Haemophilus influenzae type b infections with other vaccine(s) after completion
of A3L27 study

- Receipt of immune globulins, blood or blood-derived products in the past 3 months

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 3 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus
influenzae type b infection(s), confirmed either clinically, serologically, or
microbiologically after completion of trial A3L27

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating blood drawn

- Acute or chronic illness that, in the opinion of the Investigator, is at a stage
where it might interfere with trial conduct or completion.



Age minimum: 42 Months
Age maximum: 54 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Haemophilus Influenzae Type b

Tetanus

Poliomyelitis

Hepatitis B

Whooping Cough

Diphtheria

Intervention(s)

Biological: DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine

Biological: DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine

Biological: Infanrix hexa + Prevenar + Rotarix vaccine

Primary Outcome(s)

Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine [Time Frame: Up to 60 days following enrollment]

Secondary Outcome(s)

Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine [Time Frame: Up to 12 months following enrollment]

Secondary ID(s)

U1111-1122-2457

A3L28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors