Study of the Booster Effect of DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01444781
First received: September 29, 2011
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

  • To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
  • To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
  • To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Condition Intervention Phase
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Biological: DTaP-IPV-Hep B-PRP-T combined vaccine + Pneumococcal polysaccharide
Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide
Biological: DTaP-IPV-Hep B-PRP-T + Pneumococcal polysaccharide vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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: Day 0 (pre-vaccination) ] [ Designated as safety issue: No ]
  • The immunogenicity (for all valences) after the booster doses of DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ vaccine [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants reporting solicited and unsolicited adverse events after booster administration of DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ vaccine. [ Time Frame: Day 0 to up to 12 months post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site: Tenderness, Redness, Swelling, and Extensive swelling of vaccinated limb: Solicited Systemic Reactions: Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Unsolicited adverse events including serious adverse events and deaths


Enrollment: 1106
Study Start Date: September 2011
Study Completion Date: October 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Participants previously primed with DTaP-IPV-Hep B-PRP-T, will receive one dose of DTaP-IPV-Hep B-PRP-T vaccine + one dose of Prevenar™
Biological: DTaP-IPV-Hep B-PRP-T combined vaccine + Pneumococcal polysaccharide
0.5 mL, Intramuscular one left and right thigh
Other Names:
  • DTaP-IPV-Hep B-PRP-T vaccine
  • Prevenar™
Active Comparator: Study Group 2
Participants previously primed with DTaP-IPV-Hep B-PRP-T, will receive one dose of Infanrix hexa™ vaccine + one dose of Prevenar™
Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide
0.5 mL, Intramuscular each, on right and left thigh
Other Names:
  • Infanrix hexa™
  • Prevenar™
Experimental: Study Group 3
Participants previously primed with Infanrix hexa™ will receive one dose of DTaP-IPV-Hep B-PRP-T + one dose of Prevenar™.
Biological: DTaP-IPV-Hep B-PRP-T + Pneumococcal polysaccharide vaccine
0.5 mL (each), Intramuscular on right and left thigh
Other Names:
  • DTaP-IPV-Hep B-PRP-T combined vaccine
  • Prevenar™

Detailed Description:

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 12 to 24 months on the day of inclusion.
  • 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/guardian are able to attend all scheduled visits and to comply with all trial procedures.
  • 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™ and Rotarix™).

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations.
  • Planned participation in another clinical trial during the present trial period.
  • Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.
  • Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine.
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
  • 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).
  • 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.
  • History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically.
  • At high risk for opportunistic infection during the trial.
  • 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.
  • History of contraindication to receipt of pertussis-containing vaccine.
  • Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating Intramuscular vaccination.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • History of seizures .
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444781

Locations
Colombia
Cali, Colombia
Costa Rica
San José de Costa Rica, Costa Rica
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01444781     History of Changes
Other Study ID Numbers: A3L27, U1111-1112-8473
Study First Received: September 29, 2011
Last Updated: January 21, 2014
Health Authority: Colombia: National Institutes of Health
Costa Rica: Ministry of Health Costa Rica

Keywords provided by Sanofi:
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Pediatric combined vaccine
Invasive Hib infections

Additional relevant MeSH terms:
Cough
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Poliomyelitis
Tetanus
Tetany
Whooping Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases

ClinicalTrials.gov processed this record on April 20, 2014