A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01177722
First received: August 6, 2010
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.

Primary Objectives:

  • To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
  • To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

Secondary Objectives:

  • To describe in each group the immunogenicity parameters for all antigens for each vaccine
  • To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Condition Intervention Phase
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Biological: DTaP-Hep B-IPV vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of DTaP-IPV-Hep B-PRP-T Vaccine after primary vaccination. [ Time Frame: 1 month after 3rd dose of primary series ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of DTaP-IPV-Hep B-PRP-T Vaccine. [ Time Frame: 0-7 days and up to 12 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 1375
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DTaP-IPV-Hep B-PRP-T (Lot A) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Experimental: Group 2: DTaP-IPV-Hep B-PRP-T (Lot B) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Experimental: Group 3: DTaP-IPV-Hep B-PRP-T (Lot C) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Active Comparator: Group 4: Active Control Biological: DTaP-Hep B-IPV vaccine
0.5 mL, Intramuscular
Other Name: Infanrix hexa™

Detailed Description:

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.

All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

  Eligibility

Ages Eligible for Study:   42 Days to 81 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Two month old infants (42 to 81 days old) on the day of inclusion.
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
  • Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
  • Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
  • Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
  • Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
  • Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
  • Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
  • Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
  • History of seizures or encephalopathy.
  • Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177722

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

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01177722     History of Changes
Other Study ID Numbers: A3L24, UTN: U1111-1111-5801
Study First Received: August 6, 2010
Last Updated: December 12, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Costa Rica: Ministry of Health Costa Rica

Keywords provided by Sanofi:
Diphtheria
Tetanus
Whooping cough
Hepatitis B
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines

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 17, 2014