Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa® Concomitantly Administered with Prevenar® at 12 to 24 Months of Age in Healthy Latin American Infants

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004428-36-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1376

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 12 to 24 months on the day of inclusion
2) 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)
3) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
4) Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa at 2, 4 and 6 months of age according to protocol (both concomitantly administered with Prevenar [PCV7] and Rotarix)
Are the trial subjects under 18? yes
Number of subjects for this age range: 1376
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations
2) Planned participation in another clinical trial during the present trial period
3) Receipt of any vaccine in the 4 weeks preceding the booster vaccinations
4) Planned receipt of any vaccine in the 4 weeks following the trial vaccinations
5) Previous booster vaccination against pertussis, tetanus, diphtheria, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine
6) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
7) 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)
8) Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian
9) History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically
10) At high risk for opportunistic infection during the trial
11) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
12) History of contraindication to receipt of pertussis-containing vaccine:
• Encephalopathy
• Temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series
• Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series
• Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series
• Seizures with or without fever within 3 days following vaccine injection
13) Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating IM vaccination
14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
15) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
16) Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw
17) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified